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 Overview
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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.

Official Title
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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

Conditions
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Stem Cell Transplantation

Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Abatacept Group<br>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<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival in 7/8 HLA-matched Participants Treated with Study Therapy |  | Up to 180 days post transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abatacept, Orencia, Hematopoietic Stem Cell Transplantation (HSCT), aGVHD Prophylaxis, Unrelated Donor, Mismatched Donor