Trial Outcomes & Findings for T-cell Depleted Hematopoietic Stem Cell Boosts Without Conditioning for Poor Marrow Graft Function Following Allogeneic Hematopoietic Stem Cell Transplantation (NCT NCT02350777)
NCT ID: NCT02350777
Last Updated: 2018-10-09
Results Overview
will be documented by CBC checks every 2 weeks. Response will be defined by stable blood counts (ANC\>1000, Hb\>8 with absolute reticulocyte count\>20x10\^9/L ,and Plt\>50,000) without support of blood product transfusions and/or growth factors.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
1 year
Results posted on
2018-10-09
Participant Flow
Participant milestones
| Measure |
No Active Infection and/or Organ Compromise or GVHD.
This protocol includes two single-arm phase II trials to assess the efficacy and confirm the safety of administration of TCD stem cell boost or bone marrow (BM) HPC (M) boost from the original donor for patients with poor graft function after allogeneic hematopoietic stem cell transplantation.
|
Active Infection, Active or Controlled GVHD &/or Organ Compro
This protocol includes two single-arm phase II trials to assess the efficacy and confirm the safety of administration of TCD stem cell boost or bone marrow (BM) HPC (M) boost from the original donor for patients with poor graft function after allogeneic hematopoietic stem cell transplantation.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
T-cell Depleted Hematopoietic Stem Cell Boosts Without Conditioning for Poor Marrow Graft Function Following Allogeneic Hematopoietic Stem Cell Transplantation
Baseline characteristics by cohort
| Measure |
No Active Infection and/or Organ Compromise or GVHD.
n=2 Participants
This protocol includes two single-arm phase II trials to assess the efficacy and confirm the safety of administration of TCD stem cell boost or bone marrow (BM) HPC (M) boost from the original donor for patients with poor graft function after allogeneic hematopoietic stem cell transplantation.
|
Active Infection, Active or Controlled GVHD &/or Organ Compro
n=2 Participants
This protocol includes two single-arm phase II trials to assess the efficacy and confirm the safety of administration of TCD stem cell boost or bone marrow (BM) HPC (M) boost from the original donor for patients with poor graft function after allogeneic hematopoietic stem cell transplantation.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54 years
n=99 Participants
|
50 years
n=107 Participants
|
52 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: No data were collected
will be documented by CBC checks every 2 weeks. Response will be defined by stable blood counts (ANC\>1000, Hb\>8 with absolute reticulocyte count\>20x10\^9/L ,and Plt\>50,000) without support of blood product transfusions and/or growth factors.
Outcome measures
Outcome data not reported
Adverse Events
No Active Infection and/or Organ Compromise or GVHD.
Serious events: 2 serious events
Other events: 2 other events
Deaths: 1 deaths
Active Infection, Active or Controlled GVHD &/or Organ Compro
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
No Active Infection and/or Organ Compromise or GVHD.
n=2 participants at risk
This protocol includes two single-arm phase II trials to assess the efficacy and confirm the safety of administration of TCD stem cell boost or bone marrow (BM) HPC (M) boost from the original donor for patients with poor graft function after allogeneic hematopoietic stem cell transplantation.
|
Active Infection, Active or Controlled GVHD &/or Organ Compro
n=2 participants at risk
This protocol includes two single-arm phase II trials to assess the efficacy and confirm the safety of administration of TCD stem cell boost or bone marrow (BM) HPC (M) boost from the original donor for patients with poor graft function after allogeneic hematopoietic stem cell transplantation.
|
|---|---|---|
|
Cardiac disorders
Pericardial tamponade
|
50.0%
1/2 • 1 year
|
0.00%
0/2 • 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
1/2 • 1 year
|
0.00%
0/2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
50.0%
1/2 • 1 year
|
0.00%
0/2 • 1 year
|
|
Infections and infestations
Lung infection
|
50.0%
1/2 • 1 year
|
0.00%
0/2 • 1 year
|
|
Vascular disorders
Hematoma
|
50.0%
1/2 • 1 year
|
0.00%
0/2 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • 1 year
|
50.0%
1/2 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • 1 year
|
50.0%
1/2 • 1 year
|
Other adverse events
| Measure |
No Active Infection and/or Organ Compromise or GVHD.
n=2 participants at risk
This protocol includes two single-arm phase II trials to assess the efficacy and confirm the safety of administration of TCD stem cell boost or bone marrow (BM) HPC (M) boost from the original donor for patients with poor graft function after allogeneic hematopoietic stem cell transplantation.
|
Active Infection, Active or Controlled GVHD &/or Organ Compro
n=2 participants at risk
This protocol includes two single-arm phase II trials to assess the efficacy and confirm the safety of administration of TCD stem cell boost or bone marrow (BM) HPC (M) boost from the original donor for patients with poor graft function after allogeneic hematopoietic stem cell transplantation.
|
|---|---|---|
|
Investigations
Creatinine increased
|
100.0%
2/2 • Number of events 6 • 1 year
|
0.00%
0/2 • 1 year
|
|
Cardiac disorders
Pericardial tamponade
|
50.0%
1/2 • 1 year
|
0.00%
0/2 • 1 year
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/2 • 1 year
|
50.0%
1/2 • Number of events 2 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
1/2 • Number of events 3 • 1 year
|
0.00%
0/2 • 1 year
|
Additional Information
Dr. Roni Tamari, MD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-5987
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place