Abatacept Extended Dosing Compared to Abatacept Short-Term Dosing for the Prevention of Graft versus Host Disease, ABA3 Study

Active:	Yes
Cancer Type:	Hematopoietic Malignancies	NCT ID:	NCT04380740
Trial Phases:	Phase II	Protocol IDs:	20-227 (primary) NCI-2022-03010
Eligibility:	2 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Dana-Farber Harvard Cancer Center
NCI Full Details:	http://clinicaltrials.gov/show/NCT04380740

Summary

This phase II trial compares the effect of extended abatacept dose to short term abatacept dose given in combination with a calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate in preventing graft versus host disease (GVHD) after bone marrow transplant in patients with blood cancers. Sometimes the transplanted cells from a donor can attack the body's normal cells (called graft versus host disease). Abatacept is a immunomodulator drug that works to decrease the body's immune response by blocking the activation of T-cells (immune cells) to prevent bone marrow rejection and GVHD. Tacrolimus, cyclosporine, and methotrexate are standard of care drugs given after transplant to help prevent GVHD. Tacrolimus and cyclosporine are in a class of medications called immunosupressants. They work by decreasing the activity of the immune system to prevent it from attacking the transplant. Methotrexate is in a class of medications called antimetabolites. Methotrexate may help prevent GVHD by decreasing the activity of the immune system. Giving abatacept in combination with a calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate after the transplant may help prevent graft versus host disease.

Objectives

PRIMARY OBJECTIVE:
I. To determine whether an 8-dose regimen of abatacept will improve the rate of severe (grade III-IV) acute GVHD (AGVHD)-free, severe chronic GVHD (CGVHD)-free, relapse-free survival (‘SGRFS’) compared to a 4-dose regimen, during human leukocyte antigen unrelated-donor hematopoietic stem cell transplantation (HCT) for patients with hematologic malignancies.

OUTLINE: Patients are randomized into 1 of 5 groups.

GROUP A: Patients receive abatacept intravenously (IV) on days 1, 5, 14 and 28, and placebo IV on days 60, 90, 120, 150. Patients also receive methotrexate IV on days 1, 3, 6 and 11, and either tacrolimus or cyclosporine on days -2 to 180.

GROUP B: Patients receive abatacept IV on days 1, 5, 14, 28, 60, 90, 120, and 150. Patients also receive methotrexate IV on days 1, 3, 6 and 11, and either tacrolimus or cyclosporine on days -2 to 180.

GROUP C: Patients receive abatacept IV on days 1,5,14 and 28. Patients also receive methotrexate IV on days 1, 3, 6 and 11, and either tacrolimus or cyclosporine on days -2 to 180.

GROUP D: Patients receive abatacept IV on days 1,5,14 and 28 and receive placebo IV on days 60, 90, 120 and 150. Patients also receive methotrexate IV on days 1, 3, 6 and 11, and either tacrolimus or cyclosporine on days -2 to 180.

GROUP E: Patients receive abatacept IV on days 1,5,14, 28, 60, 90, 120 and 150. Patients also receive methotrexate IV on days 1, 3, 6 and 11, and either tacrolimus or cyclosporine on days -2 to 180.

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