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Completed

NCT Number: 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

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.

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Key information

Conditions

Stem Cell Transplantation

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Princeton, New Jersey, 08540, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

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

    Time frame: Up to 180 days post transplant

Secondary outcomes

  1. Overall Survival in Participants Treated with Study Therapy

    Time frame: Up to 180 days post transplant

  2. Overall Survival in Participants Treated with Study Therapy Plus Tacrolimus

    Time frame: Up to 180 days post transplant

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 16, 2022
Registry last updated
Jun 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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