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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

378 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-16

Study Completion Date

2021-02-15

Brief Summary

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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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Detailed Description

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Conditions

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Stem Cell Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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)

Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No