Trial Outcomes & Findings for Targeting the IPA and Matching for the Non-Inherited Maternal Antigen for Haplo-Cord Transplantation (NCT NCT01810588)
NCT ID: NCT01810588
Last Updated: 2025-09-02
Results Overview
We aim to identify the lowest threshold of umbilical cord total nucleated cell (TNC) dose that can be utilized assure durable umbilical cord blood engraftment in the haplo-cord transplants. The threshold will be defined as the lowest dose which assures cord blood engraftment occurs in at least 80% of subjects.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
270 participants
Primary outcome timeframe
100 days
Results posted on
2025-09-02
Participant Flow
Participant milestones
| Measure |
Cohort 1 - Minimum Cell Dose 2 x 10^7 TNC/kg
All subjects in this cohort will receive a minimal cell dose of 2 x 10\^7 total nucleated cells (TNC)/kilogram (kg) for the umbilical cord blood unit.
Haplo-cord transplantation:
All subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past.
For the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products.
In addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.
|
Cohort 2 - Minimum Cell Dose 1 x 10^7 TNC/kg
All subjects in this cohort will receive a minimal cell dose of 1 x 10\^7 total nucleated cells (TNC)/kilogram (kg) for the umbilical cord blood unit.
Haplo-cord transplantation:
All subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past.
For the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products.
In addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.
|
Cohort 3 - Minimum Cell Dose 0.5 x 10^7 TNC/kg
All subjects in this cohort will receive a minimal cell dose of 0.5 x 10\^7 total nucleated cells (TNC)/kilogram (kg) for the umbilical cord blood unit.
Haplo-cord transplantation:
All subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past.
For the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products.
In addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.
|
Cohort 4
All subjects in this cohort will receive the minimum required cell dose that is determined following the dose de-escalation portion of the study (cohorts 1 through 3)
Haplo-cord transplantation:
All subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past.
For the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products.
In addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.
|
|---|---|---|---|---|
|
Cohort 1 - Minimum Cell Dose 2 x 10^7 TN
STARTED
|
15
|
0
|
0
|
0
|
|
Cohort 1 - Minimum Cell Dose 2 x 10^7 TN
COMPLETED
|
15
|
0
|
0
|
0
|
|
Cohort 1 - Minimum Cell Dose 2 x 10^7 TN
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Cohort 2 - Minimum Cell Dose 1 x 10^7 TN
STARTED
|
0
|
20
|
0
|
0
|
|
Cohort 2 - Minimum Cell Dose 1 x 10^7 TN
COMPLETED
|
0
|
20
|
0
|
0
|
|
Cohort 2 - Minimum Cell Dose 1 x 10^7 TN
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Cohort 3 - Minimum Cell Dose 0.5 x 10^7
STARTED
|
0
|
0
|
25
|
0
|
|
Cohort 3 - Minimum Cell Dose 0.5 x 10^7
COMPLETED
|
0
|
0
|
25
|
0
|
|
Cohort 3 - Minimum Cell Dose 0.5 x 10^7
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Cohort 4
STARTED
|
0
|
0
|
0
|
210
|
|
Cohort 4
COMPLETED
|
0
|
0
|
0
|
210
|
|
Cohort 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Targeting the IPA and Matching for the Non-Inherited Maternal Antigen for Haplo-Cord Transplantation
Baseline characteristics by cohort
| Measure |
Cohort 1 - Minimum Cell Dose 2 x 10^7 TNC/kg
n=15 Participants
All subjects in this cohort will receive a minimal cell dose of 2 x 10\^7 total nucleated cells (TNC)/kilogram (kg) for the umbilical cord blood unit.
Haplo-cord transplantation:
All subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past.
For the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products.
In addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.
|
Cohort 2 - Minimum Cell Dose 1 x 10^7 TNC/kg
n=20 Participants
All subjects in this cohort will receive a minimal cell dose of 1 x 10\^7 total nucleated cells (TNC)/kilogram (kg) for the umbilical cord blood unit.
Haplo-cord transplantation:
All subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past.
For the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products.
In addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.
|
Cohort 3 - Minimum Cell Dose 0.5 x 10^7 TNC/kg
n=25 Participants
All subjects in this cohort will receive a minimal cell dose of 0.5 x 10\^7 total nucleated cells (TNC)/kilogram (kg) for the umbilical cord blood unit.
Haplo-cord transplantation:
All subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past.
For the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products.
In addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.
|
Cohort 4
n=210 Participants
All subjects in this cohort will receive the minimum required cell dose that is determined following the dose de-escalation portion of the study (cohorts 1 through 3)
Haplo-cord transplantation:
All subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past.
For the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products.
In addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.
|
Total
n=270 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
164 Participants
n=7 Participants
|
203 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
46 Participants
n=7 Participants
|
67 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
94 Participants
n=7 Participants
|
119 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
116 Participants
n=7 Participants
|
151 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
20 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
124 Participants
n=7 Participants
|
159 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
70 Participants
n=7 Participants
|
91 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
34 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
37 Participants
n=7 Participants
|
45 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
79 Participants
n=7 Participants
|
106 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
64 Participants
n=7 Participants
|
84 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
210 Participants
n=7 Participants
|
270 Participants
n=31 Participants
|
|
Primary Disease
Acute Myeloid Leukemia
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
109 Participants
n=7 Participants
|
144 Participants
n=31 Participants
|
|
Primary Disease
Acute Lymphoblastic Leukemia
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
23 Participants
n=31 Participants
|
|
Primary Disease
Chronic Myelogenous Leukemia
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Primary Disease
Hodgkin's Lymphoma
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
|
Primary Disease
Non-Hodgkin's Lymphoma
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
28 Participants
n=31 Participants
|
|
Primary Disease
Myelodysplastic Syndrome
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
44 Participants
n=7 Participants
|
50 Participants
n=31 Participants
|
|
Primary Disease
Myeloproliferative Neoplasm
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Primary Disease
Other Acute Leukemia
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Primary Disease
Other Leukemia (including Chronic Lymphocytic Leukemia)
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Primary Disease
Severe Aplastic Anemia
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 100 daysPopulation: A subset of participants were assessed to analyze the lowest threshold of umbilical cord total nucleated cell (TNC) dose. Once the lowest threshold was established, the remaining participants on study were treated based on that threshold.
We aim to identify the lowest threshold of umbilical cord total nucleated cell (TNC) dose that can be utilized assure durable umbilical cord blood engraftment in the haplo-cord transplants. The threshold will be defined as the lowest dose which assures cord blood engraftment occurs in at least 80% of subjects.
Outcome measures
| Measure |
All Patients
n=60 Participants
Haplo-cord transplantation:
For the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products.
In addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor).
|
|---|---|
|
Number of Subjects Who Achieved Engraftment With De-Escalating Umbilical Cord Total Nucleated Cell (TNC) Dose
Participants Achieving Engraftment with Minimum TNC of 2 x 10^5/kg
|
15 participants
|
|
Number of Subjects Who Achieved Engraftment With De-Escalating Umbilical Cord Total Nucleated Cell (TNC) Dose
Participants Achieving Engraftment with Minimum TNC of 1 x 10^5/kg in umbilical cord blood unit
|
18 participants
|
|
Number of Subjects Who Achieved Engraftment With De-Escalating Umbilical Cord Total Nucleated Cell (TNC) Dose
Participants Achieving Engraftment with Minimum TNC of 0.5 x 10^5/kg
|
20 participants
|
SECONDARY outcome
Timeframe: 5 years after transplantEvaluate the long term outcome of subjects undergoing haplo cord transplants using an optimally matched umbilical cord blood (UCB) graft (i.e. Survival, profession-free survival (PFS), Relapse, transplant-related mortality (TRM), toxicities, infections and GVHD)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 years from transplantationAs much as possible, UCB units will be chosen to be IPA targeted. This is not always possible. We will therefore also retrospectively analyze transplant outcomes and correlate with IPA status.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 years from transplantationAs much as possible, UCB units will be chosen to be NIMA matched. This is not always possible. We will therefore also retrospectively analyze transplant outcomes and correlate with NIMA status.
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1 - Minimum Cell Dose 2 x 10^7 TNC/kg
Serious events: 7 serious events
Other events: 6 other events
Deaths: 6 deaths
Cohort 2 - Minimum Cell Dose 1 x 10^7 TNC/kg
Serious events: 9 serious events
Other events: 6 other events
Deaths: 6 deaths
Cohort 3 - Minimum Cell Dose 0.5 x 10^7 TNC/kg
Serious events: 14 serious events
Other events: 12 other events
Deaths: 11 deaths
Cohort 4
Serious events: 156 serious events
Other events: 93 other events
Deaths: 79 deaths
Serious adverse events
| Measure |
Cohort 1 - Minimum Cell Dose 2 x 10^7 TNC/kg
n=15 participants at risk
All subjects in this cohort will receive a minimal cell dose of 2 x 10\^7 total nucleated cells (TNC)/kilogram (kg) for the umbilical cord blood unit.
Haplo-cord transplantation:
All subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past.
For the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products.
In addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.
|
Cohort 2 - Minimum Cell Dose 1 x 10^7 TNC/kg
n=20 participants at risk
All subjects in this cohort will receive a minimal cell dose of 1 x 10\^7 total nucleated cells (TNC)/kilogram (kg) for the umbilical cord blood unit.
Haplo-cord transplantation:
All subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past.
For the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products.
In addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.
|
Cohort 3 - Minimum Cell Dose 0.5 x 10^7 TNC/kg
n=25 participants at risk
All subjects in this cohort will receive a minimal cell dose of 0.5 x 10\^7 total nucleated cells (TNC)/kilogram (kg) for the umbilical cord blood unit.
Haplo-cord transplantation:
All subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past.
For the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products.
In addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.
|
Cohort 4
n=210 participants at risk
All subjects in this cohort will receive the minimum required cell dose that is determined following the dose de-escalation portion of the study (cohorts 1 through 3)
Haplo-cord transplantation:
All subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past.
For the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products.
In addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.
|
|---|---|---|---|---|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
2.9%
6/210 • Number of events 7 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Renal and urinary disorders
Acute Renal Failure
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Infectious Colitis
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
2.9%
6/210 • Number of events 6 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Adenovirus Viremia
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
3.8%
8/210 • Number of events 9 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Nervous system disorders
Altered Mental Status
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.95%
2/210 • Number of events 2 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Gastrointestinal disorders
Anal Fistula
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.95%
2/210 • Number of events 2 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
1.4%
3/210 • Number of events 3 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/210 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma Exacerbation
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.95%
2/210 • Number of events 2 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Blood and lymphatic system disorders
Atypical hemolytic uremic syndrome
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 2 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Bacteremia
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
3.8%
8/210 • Number of events 8 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Cardiac disorders
Cardiac disorders, other - Junctional rhythym
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/210 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.95%
2/210 • Number of events 2 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
1.9%
4/210 • Number of events 4 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Nervous system disorders
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Cardiac disorders
Congestive Heart Failure
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 2 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Investigations
Cord blood unit clot
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Investigations
Cord colitis
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
COVID-19 Infection
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
3.3%
7/210 • Number of events 7 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
1.4%
3/210 • Number of events 3 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Cytomegalovirus meningoencephalitis
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Cytomegalovirus pneumonitis
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 2 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Cytomegalovirus Retinitis
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Cytomegalovirus Viremia
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
5.2%
11/210 • Number of events 11 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/210 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
1/15 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
5.2%
11/210 • Number of events 11 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.3%
2/15 • Number of events 2 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
2.4%
5/210 • Number of events 5 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Nervous system disorders
Encephalitis
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
1.4%
3/210 • Number of events 3 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Epstein-Barr Virus Viremia
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.95%
2/210 • Number of events 2 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
General disorders
Failure to Thrive
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
3.8%
8/210 • Number of events 8 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
5.2%
11/210 • Number of events 11 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Investigations
Fever
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
1.9%
4/210 • Number of events 5 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Fungal Pneumonia
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.95%
2/210 • Number of events 2 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Fungal sinusitis
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.95%
2/210 • Number of events 2 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Gastrointestinal disorders
Gastrointestinal bleed
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
1.4%
3/210 • Number of events 3 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Nervous system disorders
Headache
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.95%
2/210 • Number of events 2 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Blood and lymphatic system disorders
Hemolytic Anemia
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.95%
2/210 • Number of events 2 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Herpes Simplex Virus Infection
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Human Herpes Virus 6 Infection
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.95%
2/210 • Number of events 2 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Vascular disorders
Hypertension
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.95%
2/210 • Number of events 2 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Vascular disorders
Hypotension
|
6.7%
1/15 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
8.0%
2/25 • Number of events 2 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
2.4%
5/210 • Number of events 5 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
3.3%
7/210 • Number of events 8 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
General disorders
Infusion-related Reaction
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/210 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Nervous system disorders
Intracranial Hemorrhage
|
33.3%
5/15 • Number of events 7 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
2.4%
5/210 • Number of events 7 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
JC Virus Infection
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mucoepidermoid carcinoma
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
General disorders
Multi-organ Failure
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
8.0%
2/25 • Number of events 2 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/210 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.95%
2/210 • Number of events 2 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Musculoskeletal and connective tissue disorders
Osteomyelitis
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Odynophagia
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
1.4%
3/210 • Number of events 4 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Cardiac disorders
Pericardial Tamponade
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.95%
2/210 • Number of events 2 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.95%
2/210 • Number of events 2 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.95%
2/210 • Number of events 2 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Pneumonia
|
13.3%
2/15 • Number of events 2 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
14.8%
31/210 • Number of events 33 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Injury, poisoning and procedural complications
Post-operative hemorrhage
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Blood and lymphatic system disorders
Post-transplant Lymphoproliferative Disorder
|
13.3%
2/15 • Number of events 2 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
4.3%
9/210 • Number of events 9 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Vascular disorders
Pulmonary embolism
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
1.4%
3/210 • Number of events 3 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hemorrhage
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
6.7%
1/15 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary veno-occlusive disease
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.7%
1/15 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
6.7%
1/15 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
10.0%
2/20 • Number of events 2 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
20.0%
5/25 • Number of events 6 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
7.1%
15/210 • Number of events 16 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Sepsis
|
20.0%
3/15 • Number of events 3 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
10.0%
2/20 • Number of events 2 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
10.0%
21/210 • Number of events 22 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Gastrointestinal disorders
Small bowel obstruction
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Nervous system disorders
Stroke
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
1.4%
3/210 • Number of events 3 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Skin and subcutaneous tissue disorders
Sweet's Syndrome
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Nervous system disorders
Syncope
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Blood and lymphatic system disorders
Thrombotic Microangiopathy
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Toxoplasmosis infection
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Upper Respiratory Infection
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
2.9%
6/210 • Number of events 7 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Varicella zoster infection
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
3.3%
7/210 • Number of events 7 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
1.4%
3/210 • Number of events 3 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Hepatobiliary disorders
Veno-occlusive disease
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Investigations
Acute Graft-versus-Host Disease
|
13.3%
2/15 • Number of events 2 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
8.6%
18/210 • Number of events 18 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Investigations
Chronic Graft-versus-Host Disease
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.95%
2/210 • Number of events 2 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Investigations
Graft Failure
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
12.0%
3/25 • Number of events 3 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
4.8%
10/210 • Number of events 10 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
Other adverse events
| Measure |
Cohort 1 - Minimum Cell Dose 2 x 10^7 TNC/kg
n=15 participants at risk
All subjects in this cohort will receive a minimal cell dose of 2 x 10\^7 total nucleated cells (TNC)/kilogram (kg) for the umbilical cord blood unit.
Haplo-cord transplantation:
All subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past.
For the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products.
In addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.
|
Cohort 2 - Minimum Cell Dose 1 x 10^7 TNC/kg
n=20 participants at risk
All subjects in this cohort will receive a minimal cell dose of 1 x 10\^7 total nucleated cells (TNC)/kilogram (kg) for the umbilical cord blood unit.
Haplo-cord transplantation:
All subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past.
For the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products.
In addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.
|
Cohort 3 - Minimum Cell Dose 0.5 x 10^7 TNC/kg
n=25 participants at risk
All subjects in this cohort will receive a minimal cell dose of 0.5 x 10\^7 total nucleated cells (TNC)/kilogram (kg) for the umbilical cord blood unit.
Haplo-cord transplantation:
All subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past.
For the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products.
In addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.
|
Cohort 4
n=210 participants at risk
All subjects in this cohort will receive the minimum required cell dose that is determined following the dose de-escalation portion of the study (cohorts 1 through 3)
Haplo-cord transplantation:
All subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past.
For the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products.
In addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.
|
|---|---|---|---|---|
|
Infections and infestations
Cytomegalovirus viremia
|
13.3%
2/15 • Number of events 2 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
10.0%
2/20 • Number of events 2 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
16.0%
4/25 • Number of events 4 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
14.3%
30/210 • Number of events 31 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Bacteremia
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
C. difficile colitis
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
15.0%
3/20 • Number of events 3 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
12.0%
3/25 • Number of events 3 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
14.3%
30/210 • Number of events 33 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Candida esophagitis
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
1.4%
3/210 • Number of events 3 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Catheter Related Infection
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Cellulitis
|
6.7%
1/15 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
1.9%
4/210 • Number of events 4 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
General disorders
Fever
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/210 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Hepatitis B Reactivation
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/210 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Human Herpes Virus 6 Infection
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
1.4%
3/210 • Number of events 3 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Herpes Simplex Virus Infection
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
1.9%
4/210 • Number of events 4 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Infectious Diarrhea
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
6.7%
14/210 • Number of events 14 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
5.2%
11/210 • Number of events 11 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Otitis media
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.95%
2/210 • Number of events 2 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.95%
2/210 • Number of events 2 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.95%
2/210 • Number of events 2 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Vaginal yeast infection
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/20 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.48%
1/210 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/15 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
5.0%
1/20 • Number of events 2 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
0.00%
0/25 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
4.3%
9/210 • Number of events 9 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
|
Infections and infestations
Upper Respiratory Infection
|
26.7%
4/15 • Number of events 4 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
20.0%
5/25 • Number of events 6 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
12.4%
26/210 • Number of events 33 • Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place