N/A
Completed N=7
Safety of Post-transplant Alpha-beta Depleted T-cell Infusion Following Haploidentical Stem Cell Transplant (Haplo SCT)
Hematologic Neoplasms · graft-versus-host disease
Source: ClinicalTrials.gov NCT02193880 ↗
Enrolled (actual)
7
Serious AEs
50.0%
Results posted
Jan 2019
Primary outcomePrimary: Number of Participants That Experience Acute Haploidentical Alpha Beta Depleted Transplant (aGVHD) — 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Experience Acute Haploidentical Alpha Beta Depleted Transplant (aGVHD) |
— | — |
| PRIMARY Number of Participants That Experience Chronic Haploidentical Alpha Beta Depleted Transplant (cGVHD) |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02193880). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.