Non Hodgkin Lymphoma Clinical Trial

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

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.

View Eligibility Criteria

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)

Study is for people with:

Non Hodgkin Lymphoma

Estimated Enrollment:

378

Study ID:

NCT05421299

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There is 1 Location for this study

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Local Institution
Princeton New Jersey, 08540, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Estimated Enrollment:

378

Study ID:

NCT05421299

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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