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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT05421299

Collaborator

(none)

378

Enrollment

Location

Actual Duration (Months)

22.2

Patients Per Site Per Month

Study Details

Study Description

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). Participants were included if their donors were unrelated and had 1-allele mismatched human leukocyte antigen (HLA) status.

Condition or Disease	Intervention/Treatment	Phase
Stem Cell Transplantation

Study Design

Study Type:

Observational

Actual Enrollment :

378 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Overall Survival in 7/8 HLA-Matched Hematopoietic Stem Cell Transplantation Patients Treated With Abatacept Combined With a Calcineurin Inhibitor and Methotrexate- An Analysis of the Center for International Blood and Marrow Transplant Research (CIBMTR) Database

Actual Study Start Date :

Sep 16, 2019

Actual Primary Completion Date :

Feb 15, 2021

Actual Study Completion Date :

Feb 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Abatacept Group Participants with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myelogenous leukemia (CML), myelodysplastic syndromes (MDS), hodgkin lymphoma (HL), or non-hodgkin lymphoma (NHL) who have a bone marrow (BM) or peripheral blood (PB) stem cell donor who is HLA-matched at 7/8 loci (A, B, C, DRB1) who received abatacept.
Comparator Group Participants with AML, ALL, CML, MDS, HL, or NHL who have a BM or PB stem cell donor who is HLA-matched at 7/8 loci (A, B, C, DRB1) who did not receive abatacept.

Outcome Measures

Primary Outcome Measures

Overall Survival in 7/8 HLA-matched Participants Treated with Study Therapy [Up to 180 days post transplant]

Secondary Outcome Measures

Overall Survival in Participants Treated with Study Therapy [Up to 180 days post transplant]
Overall Survival in Participants Treated with Study Therapy Plus Tacrolimus [Up to 180 days post transplant]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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)