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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05421299

Enrollment

378

Registered

2022-06-16

Start date

2019-09-16

Completion date

2021-02-15

Last updated

2022-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stem Cell Transplantation

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

Measure	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

Countries

United States

Outcome results