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

NCT02193880 | Completed Results DMC FDA Device

• 1 other identifier: UAB 1397
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematologic Neoplasms; Graft-Versus-Host Disease

Keywords

stem cell transplant

Outcome Measures

Primary Outcomes (2)

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

  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)

  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.

Study Arms (1)

Alpha-beta depleted T-cell infusion

OTHER

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

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

Interventions

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

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

Alpha-beta depleted T-cell infusion

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Ayman Saad: lead

Study Sites (1)

UAB Medical Center (University of Alabama at Birmingham)

Birmingham, Alabama, 35233, United States

Location

Related Publications (35)

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Related Links

• Click here for more information about the Bone Marrow Transplantation and Cell Therapy Program at the University of Alabama at Birmingham.

MeSH Terms

Conditions

Hematologic Neoplasms; Graft vs Host Disease

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases

Results Point of Contact

• Title: Tiffany D Hill
• Organization: University of Alabama at Birmingham

tiffanydhill@uabmc.edu

205-996-8023

Study Officials

• Ayman Saad, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc Prof Medicine M.D.

Study Record Dates

• First Submitted: July 14, 2014
• First Posted: July 18, 2014
• Study Start: October 9, 2014
• Primary Completion: March 13, 2018
• Study Completion: March 13, 2018
• Last Updated: April 25, 2019
• Results First Posted: January 8, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)