Status:
COMPLETED
A Study to Assess 7/8 HLA-matched Hematopoietic Stem Cell Transplantation Participants Treated With or Without Abatacept in Combination With a Calcineurin Inhibitor and Methotrexate
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Stem Cell Transplantation
Eligibility:
All Genders
6+ years
Brief Summary
The purpose of this study is to estimate overall survival (OS) for participants treated with abatacept versus those not treated with abatacept prior to hematopoietic stem cell transplantation (HSCT). ...
Eligibility Criteria
Inclusion
- Participants who underwent first allogenic transplant in the US
- Participants with an unrelated donor who are HLA-matched at 7/8 loci (A, B, C, DRB1)
- Participants at least 6 years old with weight at least 20 kilograms
- Participants with a Karnofsky/Lansky Performance Score ≥80%
- Participants whose first allogeneic transplant occurred from January 1, 2011 to December 31, 2018
- Participants with any of the following diseases: AML, ALL, CML, MDS, HL, NHL
- Participants with any of the following graft versus host disease (GVHD) prophylaxis treatments:
- CNI plus MTX (with or without ATG and with or without abatacept); or
- Post-transplant cyclophosphamide (PT-Cy) without antithymocyte globulin (ATG)
- Participants treated with any of the following conditioning regiments: total body irradiation (TBI)/cyclophosphamide (Cy), busulfan (Bu)/Cy, Bu/fludarabine (flu), Flu/Melphalan (MEL)
Exclusion
- Participants with missing information on ATG (yes/no)
- Participants receiving alemtuzumab (Campath)
- Participants with cord blood grafts
- Participants with non-MDS myeloproliferative disorders (NOTE: Participants with chronic myelomonocytic leukemia \[CMMoL\] will be included)
- Participants who did not consent to participate in research
- Participants treated at embargoed centers for research
- Participants treated with abatacept and ATG
- Among non-abatacept treated participants, participants transplanted at centers with abatacept trial participants
- Participants with any of the following missing propensity score variables:
- Disease status at transplantation (early, intermediate, advanced HL and NHL-chemosensitive)
- Age
- Gender (male, female)
- HSCT graft source (bone marrow \[BM\], peripheral blood \[PB\])
- Conditioning intensity (myeloablative, non-myeloablative / reduced intensity)
- Karnofsky/Lansky Performance Score (80%, 90-100%)
- CNI type (tacrolimus, CsA)
Key Trial Info
Start Date :
September 16 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 15 2021
Estimated Enrollment :
378 Patients enrolled
Trial Details
Trial ID
NCT05421299
Start Date
September 16 2019
End Date
February 15 2021
Last Update
June 16 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Local Institution
Princeton, New Jersey, United States, 08540