Clinical trial NCT05421299: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stem Cell Transplantation
Keywords: Abatacept
Orencia
Hematopoietic Stem Cell Transplantation (HSCT)
aGVHD Prophylaxis
Unrelated Donor
Mismatched Donor
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-06-16
Enrollment: 378
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study uses data routinely collected into the Center for International Blood and Marrow Transplant Research (CIBMTR) database. From the patterns of use analysis of the CIBMTR database, the majority of participants who received calcineurin inhibitor (CNI) plus methotrexate (MTX) plus abatacept were treated between 2011 and 2018. The study population has been selected to approximate the inclusion and exclusion criteria of the ABA2 clinical trial as closely as possible.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Overall Survival in 7/8 HLA-matched Participants Treated with Study Therapy
timeFrame: Up to 180 days post transplant
Secondary outcomes:
measure: Overall Survival in Participants Treated with Study Therapy
timeFrame: Up to 180 days post transplant
measure: Overall Survival in Participants Treated with Study Therapy Plus Tacrolimus
timeFrame: Up to 180 days post transplant
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Local Institution
state: New Jersey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: