Graft-Versus-Host Disease, Hematologic Neoplasms
Conditions
Keywords
stem cell transplant
Brief summary
The purpose of this study is to determine the safety and efficacy of post-transplant cyclophosphamide and a post-transplant infusion of donor cells, that have been specially processed to remove alpha beta t-cells, in patients undergoing a haploidentical allogeneic stem cell transplant to help reduce the risk of relapse without increasing the risk of graft-versus-host disease.
Detailed description
Transplant patients participating in this clinical trial will receive one of 3 standard pre-transplant chemotherapy preparative regimens as appropriate for their specific disease. They will then receive a standard non-manipulated donor stem cell infusion on transplant day (day 0) followed by cyclophosphamide (days +3 and +4) and an alpha-beta t-cell reduced donor stem cell infusion on day +7.
Interventions
DEVICEAlpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.
Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.
Sponsors
Ayman Saad
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Neoplastic hematological disorder with indication of allogeneic transplant * No available suitable HLA-matched donor * Adequate cardiac, pulmonary, renal, and hepatic function * Karnofsky performance status score greater than or equal to 70%
Exclusion criteria
* Medication non-compliance * No appropriate caregiver identified * Uncontrolled medical or psychiatric disorder * Active central nervous system (CNS) neoplastic involvement * Known allergy to Dimethyl Sulfoxide * HIV1 or HIV2 positive * Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Experience Acute Haploidentical Alpha Beta Depleted Transplant (aGVHD) | From baseline and before day +100 of transplant. | Patients will be monitored for Grade IV aGVHD and organ toxicity. Acute assessment will be done using the modified Keystone (Glucksberg) consensus criteria. |
| Number of Participants That Experience Chronic Haploidentical Alpha Beta Depleted Transplant (cGVHD) | From baseline and before day +100 of transplant. | Patients will be monitored for Grade IV cGVHD and organ toxicity. Chronic assessment will be done using the conventional criteria. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | patients did not collect enough HPC | 3 |
Baseline characteristics
| Characteristic | Alpha-beta Depleted T-cell Infusion |
|---|---|
| Age, Continuous | 48 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 4 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 4 |
| other Total, other adverse events | 2 / 4 |
| serious Total, serious adverse events | 2 / 4 |
Outcome results
Primary
Number of Participants That Experience Acute Haploidentical Alpha Beta Depleted Transplant (aGVHD)
Patients will be monitored for Grade IV aGVHD and organ toxicity. Acute assessment will be done using the modified Keystone (Glucksberg) consensus criteria.
Time frame: 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..
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Alpha-beta Depleted T-cell Infusion | Number of Participants That Experience Acute Haploidentical Alpha Beta Depleted Transplant (aGVHD) | 0 Participants |
Primary
Number of Participants That Experience Chronic Haploidentical Alpha Beta Depleted Transplant (cGVHD)
Patients will be monitored for Grade IV cGVHD and organ toxicity. Chronic assessment will be done using the conventional criteria.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Alpha-beta Depleted T-cell Infusion | Number of Participants That Experience Chronic Haploidentical Alpha Beta Depleted Transplant (cGVHD) | 0 Participants |