Trial Outcomes & Findings for Expanded Access of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies (NCT NCT04260698)
NCT ID: NCT04260698
Last Updated: 2026-06-22
Results Overview
Neutrophil engraftment was defined as achieving an absolute neutrophil count (ANC) greater than or equal to 0.5 x 10\^9/L on 3 consecutive measurements by Day 42 post-transplant inclusive. The first day of the three measurements was designated the day of neutrophil engraftment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
36 participants
Primary outcome timeframe
by day 42 post-transplant inclusive
Results posted on
2026-06-22
Participant Flow
Participant milestones
| Measure |
Omidubicel
Received omidubicel
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Omidubicel
Received omidubicel
|
|---|---|
|
Overall Study
Screen-failure
|
2
|
|
Overall Study
Relapse prior to treatment
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Not approved for transplant by site committee
|
1
|
|
Overall Study
Protocol logistics
|
1
|
|
Overall Study
Production failure
|
1
|
Baseline Characteristics
Expanded Access of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies
Baseline characteristics by cohort
| Measure |
Omidubicel
n=29 Participants
Received omidubicel
|
|---|---|
|
Sex: Female, Male
Female
|
11 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=20 Participants
|
|
Age, Customized
Age at CBU shipment · 12-17 years
|
0 Participants
n=20 Participants
|
|
Age, Customized
Age at CBU shipment · 18-39 years
|
15 Participants
n=20 Participants
|
|
Age, Customized
Age at CBU shipment · 40-59 years
|
11 Participants
n=20 Participants
|
|
Age, Customized
Age at CBU shipment · 60-65 years
|
0 Participants
n=20 Participants
|
|
Age, Customized
Age at CBU shipment · >65 years
|
3 Participants
n=20 Participants
|
|
Primary diagnosis
Acute Myelogenous Leukemia (AML)
|
11 Participants
n=20 Participants
|
|
Primary diagnosis
Acute Lymphoblastic Leukemia (ALL)
|
8 Participants
n=20 Participants
|
|
Primary diagnosis
Myelodysplastic Syndrome (MDS) / Chronic Myelomonocytic Leukemia (CMML/CMMoL)
|
6 Participants
n=20 Participants
|
|
Primary diagnosis
Adult T-Cell Leukemia/Lymphoma
|
2 Participants
n=20 Participants
|
|
Primary diagnosis
Chronic Myelogenous Leukemia (CML)
|
1 Participants
n=20 Participants
|
|
Primary diagnosis
Lymphoma
|
1 Participants
n=20 Participants
|
|
HLA match (/6)
4/6
|
14 Participants
n=20 Participants
|
|
HLA match (/6)
5/6
|
13 Participants
n=20 Participants
|
|
HLA match (/6)
6/6
|
2 Participants
n=20 Participants
|
|
HLA match (/8)
4/8
|
4 Participants
n=20 Participants
|
|
HLA match (/8)
5/8
|
14 Participants
n=20 Participants
|
|
HLA match (/8)
6/8
|
7 Participants
n=20 Participants
|
|
HLA match (/8)
7/8
|
3 Participants
n=20 Participants
|
|
HLA match (/8)
8/8
|
1 Participants
n=20 Participants
|
|
Age, Continuous
|
39.0 Years
n=20 Participants
|
PRIMARY outcome
Timeframe: by day 42 post-transplant inclusivePopulation: Analysis among engrafters
Neutrophil engraftment was defined as achieving an absolute neutrophil count (ANC) greater than or equal to 0.5 x 10\^9/L on 3 consecutive measurements by Day 42 post-transplant inclusive. The first day of the three measurements was designated the day of neutrophil engraftment.
Outcome measures
| Measure |
Omidubicel
n=26 Participants
Received omidubicel
|
|---|---|
|
Time From Transplant to Neutrophil Engraftment
|
11.5 Days
Interval 7.0 to 35.0
|
PRIMARY outcome
Timeframe: by day 42 post-transplant inclusiveDeath, second transplant, and relapse were competing risks at the time they occur if they occur prior to neutrophil engraftment, and no transplant was a competing risk at Day 0. If the patient failed to achieve neutrophil engraftment, they were considered to have a competing risk at Day 43.
Outcome measures
| Measure |
Omidubicel
n=29 Participants
Received omidubicel
|
|---|---|
|
Cumulative Incidence of Neutrophil Engraftment
|
0.90 Proportion of Participants
Interval 0.68 to 0.97
|
SECONDARY outcome
Timeframe: By Day 42 and Day 180 post-transplantOutcome measures
| Measure |
Omidubicel
n=29 Participants
Received omidubicel
|
|---|---|
|
Cumulative Incidence of Platelet Engraftment >20,000 Cells/uL
Cumulative incidence by Day 42
|
0.72 Proportion of participants
Interval 0.51 to 0.86
|
|
Cumulative Incidence of Platelet Engraftment >20,000 Cells/uL
Cumulative incidence by Day 180
|
0.90 Proportion of participants
Interval 0.67 to 0.97
|
SECONDARY outcome
Timeframe: By Day 730 post-transplantTime to platelet engraftment \>20,000 cells/ul was defined as the number of days from transplant to the first day of a minimum of 3 consecutive measurements on different days in which the platelet count is 20,000 cells/ul or higher with no platelet transfusion within the previous 7 days (count day of engraftment as one of the preceding 7 days) was calculated. The first day of the three measurements was designated the day of platelet engraftment.
Outcome measures
| Measure |
Omidubicel
n=29 Participants
Received omidubicel
|
|---|---|
|
Time to Platelet Engraftment >20,000 Cells/uL
|
33 Days
Interval 24.0 to 58.0
|
SECONDARY outcome
Timeframe: By Day 42 and Day 180 post-transplantPopulation: Analysis among engrafters
Outcome measures
| Measure |
Omidubicel
n=29 Participants
Received omidubicel
|
|---|---|
|
Cumulative Incidence of Platelet Engraftment >50,000 Cells/uL
Cumulative incidence by Day 42 post-transplant
|
0.48 Proportion of participants
Interval 0.29 to 0.65
|
|
Cumulative Incidence of Platelet Engraftment >50,000 Cells/uL
Cumulative incidence by Day 180 post-transplant
|
0.83 Proportion of participants
Interval 0.61 to 0.93
|
SECONDARY outcome
Timeframe: By Day 730 post-transplantTime to platelet engraftment \>50,000 cells/ul was defined as the number of days from transplant to the first day of a minimum of 3 consecutive measurements on different days in which the platelet count is 50,000 cells/ul or higher with no platelet transfusion within the previous 7 days (count day of engraftment as one of the preceding 7 days) was calculated. The first day of the three measurements was designated the day of platelet engraftment.
Outcome measures
| Measure |
Omidubicel
n=29 Participants
Received omidubicel
|
|---|---|
|
Time to Platelet Engraftment >50,000 Cells/uL
|
41 Days
Interval 27.0 to 239.0
|
SECONDARY outcome
Timeframe: By Day 180, Day 365 and Day 730 post-transplantNon-relapse mortality was defined as any death not preceded by relapse.
Outcome measures
| Measure |
Omidubicel
n=29 Participants
Received omidubicel
|
|---|---|
|
Non-relapse Mortality
Cumulative incidence by Day 180 post-transplant
|
0.03 Proportion of participants
Interval 0.0 to 0.15
|
|
Non-relapse Mortality
Cumulative incidence by Day 365 post-transplant
|
0.07 Proportion of participants
Interval 0.01 to 0.2
|
|
Non-relapse Mortality
Cumulative incidence by Day 730 post-transplant
|
0.10 Proportion of participants
Interval 0.03 to 0.25
|
SECONDARY outcome
Timeframe: By Day 180, Day 365 and Day 730 post-transplantOS probability was defined as the probability of participants remaining alive at specified time points following transplantation, estimated using Kaplan-Meier methods.
Outcome measures
| Measure |
Omidubicel
n=29 Participants
Received omidubicel
|
|---|---|
|
Overall Survival (OS)
OS probability by Day 180 post-transplant
|
0.93 Proportion probability
Interval 0.75 to 0.98
|
|
Overall Survival (OS)
OS probability by Day 365 post-transplant
|
0.86 Proportion probability
Interval 0.67 to 0.95
|
|
Overall Survival (OS)
OS probability by Day 730 post-transplant
|
0.79 Proportion probability
Interval 0.6 to 0.9
|
SECONDARY outcome
Timeframe: By Day 365 and Day 730 post-transplantDisease-free survival was defined as the survival without disease relapse or death from any cause, whichever came first.
Outcome measures
| Measure |
Omidubicel
n=29 Participants
Received omidubicel
|
|---|---|
|
Disease Free Survival (DFS)
DFS probability by Day 365 post-transplant
|
0.79 Proportion probability
Interval 0.6 to 0.9
|
|
Disease Free Survival (DFS)
DFS probability by Day 730 post-transplant
|
0.76 Proportion probability
Interval 0.56 to 0.88
|
SECONDARY outcome
Timeframe: By day 100 and Day 730 post-transplantPatients considered to have donor chimerism when they had at least 95% donor chimerism
Outcome measures
| Measure |
Omidubicel
n=29 Participants
Received omidubicel
|
|---|---|
|
Donor Chimerism
KM of Donor Chimerism by Day 100
|
0.96 Proportion Probability
|
|
Donor Chimerism
KM of Donor Chimerism by Day 730
|
0.96 Proportion Probability
|
SECONDARY outcome
Timeframe: By Day 730 post-transplantOutcome measures
| Measure |
Omidubicel
n=29 Participants
Received omidubicel
|
|---|---|
|
Secondary Graft Failure (SGF)
|
0.00 Proportion of Participants
|
SECONDARY outcome
Timeframe: By Day 365 and Day 730 post-transplantOutcome measures
| Measure |
Omidubicel
n=29 Participants
Received omidubicel
|
|---|---|
|
Disease Relapse
Cumulative incidence of disease relapse by Day 365 post-transplant
|
0.14 Proportion of Participants
Interval 0.04 to 0.29
|
|
Disease Relapse
Cumulative incidence of disease relapse by Day 730 post-transplant
|
0.14 Proportion of Participants
Interval 0.04 to 0.29
|
SECONDARY outcome
Timeframe: By Day 100 post-transplantDeath, failure to achieve neutrophil engraftment, secondary graft failure, and relapse were considered competing events.
Outcome measures
| Measure |
Omidubicel
n=29 Participants
Received omidubicel
|
|---|---|
|
Cumulative Incidence of Acute GvHD Grade II-IV
|
0.55 Proportion of Participants
Interval 0.35 to 0.71
|
SECONDARY outcome
Timeframe: By Day 100 post-transplantDeath, failure to achieve neutrophil engraftment, secondary graft failure, and relapse were considered competing events.
Outcome measures
| Measure |
Omidubicel
n=29 Participants
Received omidubicel
|
|---|---|
|
Cumulative Incidence of aGvHD Grade III-IV
|
0.17 Proportion of Participants
Interval 0.06 to 0.33
|
SECONDARY outcome
Timeframe: By Day 180 and Day 730 post-transplantDeath, failure to achieve neutrophil engraftment, secondary graft failure, and relapse were considered competing events.
Outcome measures
| Measure |
Omidubicel
n=29 Participants
Received omidubicel
|
|---|---|
|
Cumulative Incidence of Chronic GvHD
Cumulative Incidence at Day 180
|
0.07 Proportion of Patients
Interval 0.01 to 0.2
|
|
Cumulative Incidence of Chronic GvHD
Cumulative Incidence at Day 730
|
0.21 Proportion of Patients
Interval 0.08 to 0.37
|
SECONDARY outcome
Timeframe: By Day 365 and Day 730 post-transplantChronic graft versus host disease-free, relapse-free survival (cGRFS) was defined as chronic GvHD, relapse, or death by any cause.
Outcome measures
| Measure |
Omidubicel
n=29 Participants
Received omidubicel
|
|---|---|
|
Chronic GvHD-free Relapse-free Survival (cGRFS)
KM of cGRFS by Day 365
|
0.66 Proportion Probability
|
|
Chronic GvHD-free Relapse-free Survival (cGRFS)
KM of cGRFS by Day 730
|
0.55 Proportion Probability
|
SECONDARY outcome
Timeframe: By Day 365 and Day 730 post-transplantGraft versus host disease-free, relapse-free survival (GRFS) was defined as acute GvHD Grade III-IV, chronic GvHD, relapse, or death by any cause
Outcome measures
| Measure |
Omidubicel
n=29 Participants
Received omidubicel
|
|---|---|
|
GvHD-free Relapse-free Survival (GRFS)
KM of GRFS by Day 365
|
0.48 Proportion Probability
|
|
GvHD-free Relapse-free Survival (GRFS)
KM of GRFS by Day 730
|
0.41 Proportion Probability
|
Adverse Events
Omidubicel
Serious events: 21 serious events
Other events: 29 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Omidubicel
n=29 participants at risk
Omidubicel is a cryopreserved stem/progenitor cell based product comprised of:
1. Ex vivo expanded, umbilical cord blood-derived hematopoietic CD34+ progenitor cells (cultured fraction (CF))
2. the non-cultured cell fraction of the same Cord Blood Unit (CBU) (Non-cultured Fraction (NF)) consisting of mature myeloid and lymphoid cells.
Both fractions, i.e. CF and NF, will be kept frozen until they are thawed and infused on the day of transplantation.
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
10.3%
3/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
General disorders
Pyrexia
|
6.9%
2/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Infections and infestations
BK virus infection
|
3.4%
1/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Infections and infestations
Bacteremia
|
3.4%
1/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Infections and infestations
Covid-19
|
3.4%
1/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Infections and infestations
Clostrodium difficile colitis
|
3.4%
1/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Infections and infestations
Clostrodium Difficile infection
|
3.4%
1/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Infections and infestations
Cytomegalovirus enteritis
|
3.4%
1/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Infections and infestations
Herpes simplex
|
3.4%
1/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Infections and infestations
Pneumonia
|
3.4%
1/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Infections and infestations
Covid-19 pneumonia
|
3.4%
1/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Infections and infestations
Staphylococcal infection
|
3.4%
1/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Infections and infestations
Urinary tract infection
|
3.4%
1/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
General disorders
Death
|
3.4%
1/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
General disorders
Multiple organ disfunction syndrome
|
3.4%
1/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
General disorders
Non-cardiac chest pain
|
3.4%
1/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Cardiac disorders
Acute myocardial infarction
|
3.4%
1/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Cardiac disorders
Atrial flutter
|
3.4%
1/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Cardiac disorders
Cardiomyopathy
|
3.4%
1/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Cardiac disorders
Pericardial effusion
|
3.4%
1/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Injury, poisoning and procedural complications
Transplant failure
|
3.4%
1/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Injury, poisoning and procedural complications
Refractoriness to platelet transfusion
|
3.4%
1/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Injury, poisoning and procedural complications
Tendon injury
|
3.4%
1/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Metabolism and nutrition disorders
Failure to thrive
|
3.4%
1/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.4%
1/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Metabolism and nutrition disorders
Hypervolemia
|
3.4%
1/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukemia recurrent
|
3.4%
1/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukemia recurrent
|
3.4%
1/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Post transplant lymphoproliferative disorder
|
3.4%
1/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Renal and urinary disorders
Acute kidney injury
|
3.4%
1/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Renal and urinary disorders
Cystitis hemorrhagic
|
3.4%
1/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
3.4%
1/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.4%
1/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.4%
1/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
3.4%
1/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
3.4%
1/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Nervous system disorders
Syncope
|
3.4%
1/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Vascular disorders
Venoocclusive disease
|
3.4%
1/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
Other adverse events
| Measure |
Omidubicel
n=29 participants at risk
Omidubicel is a cryopreserved stem/progenitor cell based product comprised of:
1. Ex vivo expanded, umbilical cord blood-derived hematopoietic CD34+ progenitor cells (cultured fraction (CF))
2. the non-cultured cell fraction of the same Cord Blood Unit (CBU) (Non-cultured Fraction (NF)) consisting of mature myeloid and lymphoid cells.
Both fractions, i.e. CF and NF, will be kept frozen until they are thawed and infused on the day of transplantation.
|
|---|---|
|
General disorders
Fatigue
|
82.8%
24/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
General disorders
Mucosal inflammation
|
69.0%
20/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
General disorders
Edema
|
62.1%
18/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
General disorders
Pain
|
62.1%
18/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
General disorders
Chills
|
34.5%
10/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
General disorders
Pyrexia
|
6.9%
2/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
82.8%
24/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
69.0%
20/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Metabolism and nutrition disorders
Hypokalemia
|
65.5%
19/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
58.6%
17/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
44.8%
13/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
44.8%
13/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Metabolism and nutrition disorders
Dehydration
|
10.3%
3/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Metabolism and nutrition disorders
Hypervolemia
|
10.3%
3/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
82.8%
24/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Gastrointestinal disorders
Diarrhea
|
69.0%
20/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Gastrointestinal disorders
Vomiting
|
48.3%
14/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Gastrointestinal disorders
Dyspepsia
|
31.0%
9/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Gastrointestinal disorders
Dysphagia
|
31.0%
9/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Gastrointestinal disorders
Oesophagitis
|
24.1%
7/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Gastrointestinal disorders
Constipation
|
17.2%
5/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Gastrointestinal disorders
Abdominal distension
|
10.3%
3/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Gastrointestinal disorders
Hemorrhoids
|
6.9%
2/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Investigations
Blood sodium abnormal
|
69.0%
20/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Investigations
Blood bilirubin increased
|
44.8%
13/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Investigations
Blood creatinine increased
|
44.8%
13/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Investigations
Transaminases increased
|
34.5%
10/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Investigations
Blood alkaline phosphatase increased
|
31.0%
9/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Investigations
Weight decreased
|
31.0%
9/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
82.8%
24/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Nervous system disorders
Dizziness
|
41.4%
12/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Nervous system disorders
Dysgeusia
|
34.5%
10/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Nervous system disorders
Headache
|
13.8%
4/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Nervous system disorders
Somnolence
|
6.9%
2/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Nervous system disorders
Tremor
|
6.9%
2/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Vascular disorders
Hypertension
|
69.0%
20/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Vascular disorders
Hemorrhage
|
37.9%
11/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Vascular disorders
Hypotension
|
17.2%
5/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Vascular disorders
Venoocclusive disease
|
6.9%
2/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
34.5%
10/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
31.0%
9/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.6%
8/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
27.6%
8/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
20.7%
6/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
6.9%
2/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Skin and subcutaneous tissue disorders
Rash
|
58.6%
17/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
34.5%
10/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.7%
6/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
13.8%
4/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
6.9%
2/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Psychiatric disorders
Insomnia
|
31.0%
9/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Psychiatric disorders
Anxiety
|
20.7%
6/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Cardiac disorders
Arrhythmia
|
37.9%
11/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Infections and infestations
Cystitis
|
6.9%
2/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Renal and urinary disorders
Dysuria
|
31.0%
9/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Renal and urinary disorders
Acute kidney injury
|
6.9%
2/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
31.0%
9/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Eye disorders
Dry eye
|
24.1%
7/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
20.7%
6/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Injury, poisoning and procedural complications
Contusion
|
6.9%
2/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Injury, poisoning and procedural complications
Transplant failure
|
6.9%
2/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
|
Immune system disorders
Hypersensitivity
|
10.3%
3/29 • Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place