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

NCT05421299 | Completed DMC

• 1 other identifier: IM101-841
• Study Type: observational
• Target: 378
• Locations: 1 country
• Sites: 1

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.

Conditions

Stem Cell Transplantation

Keywords

Abatacept; Orencia; Hematopoietic Stem Cell Transplantation (HSCT); aGVHD Prophylaxis; Unrelated Donor; Mismatched Donor

Outcome Measures

Primary Outcomes (1)

• Overall Survival in 7/8 HLA-matched Participants Treated with Study Therapy

  Up to 180 days post transplant

Secondary Outcomes (2)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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%)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution

Princeton, New Jersey, 08540, United States

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls
• Investigator Inquiry Form

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 16, 2022
• Study Start: September 16, 2019
• Primary Completion: February 15, 2021
• Study Completion: February 15, 2021
• Last Updated: June 16, 2022

Record last verified: 2022-06

Locations

US (1)