Acute Lymphoblastic Leukemia Clinical Trial
Official title:
Methotrexate or Pentostatin for Graft-versus-host Disease Prophylaxis in Risk-adapted Allogeneic Bone Marrow Transplantation for Hematologic Malignancies
The purpose of the study is to determine if participants who receive the GVHD prophylaxis medication pentostatin will have less severe hepatic toxicities than those receiving MTX. The study is estimated to have sufficient statistical power to ascertain at least a 20% improvement in day 42 NCI CTC grade 2 or above hepatic toxicity-free survival in pentostatin recipients.
Participants will be randomized to receive either methotrexate (MTX) or pentostatin for
graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow
transplant from an HLA-matched related or unrelated donor. All participants will receive a
standard backbone GVHD prophylaxis regimen (tacrolimus and sirolimus) and conditioning
(cyclophosphamide/TBI). A risk-adapted approach will be used during conditioning to further
minimize the risk of leukemia relapse based on two factors:
1. Lymphoid versus myeloid primary disease.
2. KIR compatibility between donor and host.
;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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