Safety of Post-transplant Alpha-beta Depleted T-cell Infusion Following Haploidentical Stem Cell Transplant (Haplo SCT)



Status:Active, not recruiting
Conditions:Blood Cancer, Orthopedic, Hematology
Therapuetic Areas:Hematology, Oncology, Orthopedics / Podiatry
Healthy:No
Age Range:19 - 65
Updated:1/10/2019
Start Date:October 9, 2014
End Date:March 2019

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Trial Summary
Trial Overview
Inclusion Criteria
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.

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.

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
We found this trial at
1
site
UAB Medical Center (University of Alabama at Birmingham)
Birmingham, Alabama 35233
Principal Investigator: Ayman Saad, MD
Phone: 205-934-0066
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mi
from
Birmingham, AL
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