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

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.

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Key information

Conditions

Hematologic Neoplasms Graft vs Host Disease Graft-Versus-Host Disease Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Neoplasms Neoplasms by Site

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UAB Medical Center (University of Alabama at Birmingham)

Birmingham, Alabama, 35233, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.

Device

Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.

Primary outcomes

Number of Participants That Experience Acute Haploidentical Alpha Beta Depleted Transplant (aGVHD)

Time frame: 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)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ayman Saad

Other

Registry information

Acronym: ABD

Important dates

Study start: 2014
Primary completion: 2018
Study completion: 2018
First posted: Jul 18, 2014
Registry last updated: Apr 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed