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

Status
Active
Cancer Type
Hematopoietic Malignancies
Trial Phase
Phase II
Eligibility
2 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04380740
Protocol IDs
20-227 (primary)
NCI-2022-03010
Study Sponsor
Dana-Farber Harvard Cancer Center

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 (HLA)-mismatched unrelated-donor hematopoietic stem cell transplantation (HCT) for patients with hematologic malignancies.

OUTLINE: Patients are randomized into 1 of 2 groups.

GROUP A: Patients receive abatacept intravenously (IV) over 60 minutes on days 1, 5, 15 and 28, and placebo IV over 60 minutes 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 over 60 minutes on days 1, 5, 15, 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.

After completion of study treatment, patients are followed up at 164, 180, 208, 236, 270, 292, and 365 days, and at 2 years from date of transplant.

Eligibility

  1. Must be at least 2 years old and weigh 10 kg.
  2. Must have a willing unrelated adult donor (bone marrow or peripheral blood). Donors may have a single mismatch (i.e. be a 7/8) and this mismatch may be at the allele or antigen level; however, donors with allele level disparity should be given preference over those with antigen level disparity. Patients for whom a donor is available with disparity only in the host versus graft direction (because of recipient homozygosity), will not be eligible, since this mismatching does not increase the risk for GVHD. Centers may perform extended typing (e.g. DQB1 and DPB1) according to institutional practices and use these results in selecting donors; however, it is recommended that this extending typing be used only to select between donors who are equally well matched with the recipient at the A, B, C and DRB1.
  3. All patients and/or their parents or legal guardians must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.
  4. Must have a hematologic malignancy treatable by HCT (except for those stipulated below under study exclusion criteria), which is in remission by standard testing (no patients in relapse will be included).
  5. Patients with an inherited predisposition to leukemia or otherwise hematologic malignancies that have not been associated with predisposition to transplant morbidities or non- hematologic cancers.
  6. Karnofsky performance score or Lansky Play-Performance Scale score >= 80.
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