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

Not Applicable

Completed

• Conditions: Hematologic Neoplasms; Graft-Versus-Host Disease
• Interventions: Device: Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.

• Registration Number: NCT02193880
• Lead Sponsor: Ayman Saad

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.

Study Timeline

• Study First Submitted: 2014-07-14
• Study First Submitted QC: 2014-07-16
• Study First Posted: 2014-07-18
• Study Start: 2014-10-09
• Primary Completion: 2018-03-13
• Study Completion: 2018-03-13
• Results First Submitted: 2018-12-17
• Results First Submitted QC: 2018-12-17
• Results First Posted: 2019-01-08
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-11
• Last Update Posted: 2019-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Alpha-beta depleted T-cell infusion	Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.	Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

UAB Medical Center (University of Alabama at Birmingham); 🇺🇸 Birmingham, Alabama, United States