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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02193880
Recruitment Status : Completed
First Posted : July 18, 2014
Results First Posted : January 8, 2019
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Ayman Saad, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Hematologic Neoplasms Graft-Versus-Host Disease Device: Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide. Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety of Post-transplant Alpha-beta Depleted T-cell Infusion Following Haploidentical Stem Cell Transplant (Haplo SCT)
Actual Study Start Date : October 9, 2014
Actual Primary Completion Date : March 13, 2018
Actual Study Completion Date : March 13, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02193880


Locations
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United States, Alabama
UAB Medical Center (University of Alabama at Birmingham)
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
Ayman Saad
Investigators
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Principal Investigator: Ayman Saad, MD University of Alabama at Birmingham
  Study Documents (Full-Text)

Documents provided by Ayman Saad, University of Alabama at Birmingham:
Additional Information:
Publications:
Kaplan, EL, Meier, P. Nonparametric estimation from incomplete observations. Journal of the American Statistical Association 53(282): 457-481, 1958.
Gray, RJ. A class of K-sample tests for comparing the cumulative incidence of a competing risk. The Annals of Statistics, 1141-1154, 1988.

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Responsible Party: Ayman Saad, Assoc Prof Medicine M.D., University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02193880    
Other Study ID Numbers: UAB 1397
First Posted: July 18, 2014    Key Record Dates
Results First Posted: January 8, 2019
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Ayman Saad, University of Alabama at Birmingham:
stem cell transplant
Additional relevant MeSH terms:
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Hematologic Neoplasms
Graft vs Host Disease
Immune System Diseases
Neoplasms by Site
Neoplasms
Hematologic Diseases
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists