Safety of Post-transplant Alpha-beta Depleted T-cell Infusion Following Haploidentical Stem Cell Transplant (Haplo SCT)
NCT ID: NCT02193880
Last Updated: 2019-04-25
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
7 participants
Study Classification
INTERVENTIONAL
Study Start Date
2014-10-09
Study Completion Date
2018-03-13
Brief Summary
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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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Detailed Description
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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.
Conditions
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Hematologic Neoplasms
Graft-Versus-Host Disease
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Alpha-beta depleted T-cell infusion
Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.
Group Type
OTHER
Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.
Intervention Type
DEVICE
Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.
Interventions
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Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.
Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.
Intervention Type
DEVICE
Eligibility Criteria
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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%
* 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
* 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
Minimum Eligible Age
19 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Ayman Saad
OTHER
Sponsor Role
lead
Responsible Party
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Ayman Saad
Assoc Prof Medicine M.D.
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Ayman Saad, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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UAB Medical Center (University of Alabama at Birmingham)
Birmingham, Alabama, United States
Site Status
Countries
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United States
References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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http://www.uab.edu/medicine/bonemarrow/
Click here for more information about the Bone Marrow Transplantation and Cell Therapy Program at the University of Alabama at Birmingham.
Other Identifiers
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UAB 1397
Identifier Type: -
Identifier Source: org_study_id
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