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

Stem Cell Transplantation Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05421299
• Other study ID #: IM101-841
• Status: Completed
• Start date: September 16, 2019
• Est. completion date: February 15, 2021

Study information

• Verified date: June 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 378
• Est. completion date: February 15, 2021
• Est. primary completion date: February 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Stem Cell Transplantation

Locations

Country	Name	City	State
United States	Local Institution	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival in 7/8 HLA-matched Participants Treated with Study Therapy		Up to 180 days post transplant
Secondary	Overall Survival in Participants Treated with Study Therapy		Up to 180 days post transplant
Secondary	Overall Survival in Participants Treated with Study Therapy Plus Tacrolimus		Up to 180 days post transplant

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form