Status:
ACTIVE_NOT_RECRUITING
The Safety and Efficacy of Alpha-1 Antitrypsin (AAT) for the Prevention of Graft-versus-host Disease (GVHD) in Patients Receiving Hematopoietic Cell Transplant
Lead Sponsor:
CSL Behring
Conditions:
Acute-graft-versus-host Disease
Eligibility:
All Genders
12+ years
Phase:
PHASE2
PHASE3
Brief Summary
This study is a phase 2 / 3 prospective, double-blind, randomized, multicenter, placebo-controlled study for prevention of acute GVHD (aGVHD) in participants undergoing an unrelated (matched or single...
Eligibility Criteria
Inclusion
- • Male or female participants, \>=12 years of age (\>= 18 years of age for participants at German sites only), undergoing HCT for hematological malignancies, including leukemia, lymphoma, multiple myeloma, myelodysplastic syndrome, and myeloproliferative neoplasms.
- • Planned myeloablative conditioning regimen.
- • Participants must have a related or unrelated donor as follows:
- \- Related donor must be a 6 / 6 match for human leukocyte antigen (HLA)-A, -B, at intermediate (or higher) resolution, and -DR beta 1 (DRB1) at high resolution using deoxyribonucleic acid (DNA)-based typing.
- \- Unrelated donor must be 7 / 8 or 8 / 8 match for HLA-A, -B, and -C at intermediate (or higher) resolution, and -DRB1 at high resolution using DNA-based typing.
Exclusion
- • Prior autologous or allogeneic HCT.
- • T cell depleted transplant or planned use of anti-T cell antibody therapy either ex vivo or in vivo (ie, anti thymocyte globulin \[ATG\], alemtuzumab) for GVHD prophylaxis.
- • Planned umbilical cord blood transplant.
- • Planned use of cyclophosphamide after HCT for GVHD prophylaxis.
- • Planned haploidentical donor.
Key Trial Info
Start Date :
March 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2026
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT03805789
Start Date
March 27 2019
End Date
March 31 2026
Last Update
November 4 2025
Active Locations (34)
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1
HonorHealth Scottsdale Shea Medical Center
Scottsdale, Arizona, United States, 85258
2
Johns Hopkins Hospital
St. Petersburg, Florida, United States, 33701
3
Emory University
Atlanta, Georgia, United States, 30322
4
University of Kansas Cancer Center
Westwood, Kansas, United States, 66205