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

April 11, 2019 updated by: Ayman Saad
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • UAB Medical Center (University of Alabama at Birmingham)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Alpha-beta depleted T-cell infusion
Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.
Device: Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.
Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline and before day +100 of transplant.
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.
From baseline and before day +100 of transplant.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ayman Saad

Investigators

  • Principal Investigator: Ayman Saad, MD, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2014

Primary Completion (Actual)

March 13, 2018

Study Completion (Actual)

March 13, 2018

Study Registration Dates

First Submitted

July 14, 2014

First Submitted That Met QC Criteria

July 16, 2014

First Posted (Estimate)

July 18, 2014

Study Record Updates

Last Update Posted (Actual)

April 25, 2019

Last Update Submitted That Met QC Criteria

April 11, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UAB 1397

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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