Trial Outcomes & Findings for Safety of Post-transplant Alpha-beta Depleted T-cell Infusion Following Haploidentical Stem Cell Transplant (Haplo SCT) (NCT NCT02193880)
NCT ID: NCT02193880
Last Updated: 2019-04-25
Results Overview
Patients will be monitored for Grade IV aGVHD and organ toxicity. Acute assessment will be done using the modified Keystone (Glucksberg) consensus criteria.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
From baseline and before day +100 of transplant.
Results posted on
2019-04-25
Participant Flow
Participant milestones
| Measure |
Alpha-beta Depleted T-cell Infusion
Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.
Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.: Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Alpha-beta Depleted T-cell Infusion
Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.
Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.: Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.
|
|---|---|
|
Overall Study
patients did not collect enough HPC
|
3
|
Baseline Characteristics
we report data on 4 patients who received the actual therapy. The other 3 patients did not receive the experimental therapy for NOT collecting enough T cells.
Baseline characteristics by cohort
| Measure |
Alpha-beta Depleted T-cell Infusion
n=4 Participants
Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.
Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.: Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.
|
|---|---|
|
Age, Continuous
|
48 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants • we report data on 4 patients who received the actual therapy. The other 3 patients did not receive the experimental therapy for NOT collecting enough T cells.
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants • we report data on 4 patients who received the actual therapy. The other 3 patients did not receive the experimental therapy for NOT collecting enough T cells.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline and before day +100 of transplant.Population: we report data on 4 patients who received the actual therapy. The other 3 patients did not receive the experimental therapy for NOT collecting enough CD34 HSCT..
Patients will be monitored for Grade IV aGVHD and organ toxicity. Acute assessment will be done using the modified Keystone (Glucksberg) consensus criteria.
Outcome measures
| Measure |
Alpha-beta Depleted T-cell Infusion
n=4 Participants
Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.
Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.: Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.
|
|---|---|
|
Number of Participants That Experience Acute Haploidentical Alpha Beta Depleted Transplant (aGVHD)
|
0 Participants
|
PRIMARY outcome
Timeframe: From baseline and before day +100 of transplant.Population: we report data on 4 patients who received the actual therapy. The other 3 patients did not receive the experimental therapy for NOT collecting enough CD34 HSCT.
Patients will be monitored for Grade IV cGVHD and organ toxicity. Chronic assessment will be done using the conventional criteria.
Outcome measures
| Measure |
Alpha-beta Depleted T-cell Infusion
n=4 Participants
Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.
Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.: Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.
|
|---|---|
|
Number of Participants That Experience Chronic Haploidentical Alpha Beta Depleted Transplant (cGVHD)
|
0 Participants
|
Adverse Events
Alpha-beta Depleted T-cell Infusion
Serious events: 2 serious events
Other events: 2 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Alpha-beta Depleted T-cell Infusion
n=4 participants at risk
Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.
Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.: Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.
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|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Graft Failure (not related to study)
|
50.0%
2/4 • Number of events 2 • Baseline through one year.
|
Other adverse events
| Measure |
Alpha-beta Depleted T-cell Infusion
n=4 participants at risk
Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.
Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.: Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.
|
|---|---|
|
Infections and infestations
Infection
|
50.0%
2/4 • Number of events 2 • Baseline through one year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place