Methotrexate or Pentostatin for Graft-versus-host Disease Prophylaxis in Risk-adapted Allogeneic Bone Marrow Transplantation for Hematologic Malignancies
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
Determining Whether the Hepatic Adverse Event-free (NCI Grades II-IV) Survival at Day 42 After an HLA-matched Transplant for Hematologic Malignancy Can be Improved by Using a GVHD Prophylaxis Regimen That Includes Pentostatin Rather Than MTX.
The hypothesis was that individuals receiving the drug pentostatin as GVHD prophylaxis would experience less severe hepatic toxicity than those receiving methotrexate as GVHD prophylaxis. The study is estimated to have sufficient statistical power to ascertain at least a 20% improvement in day 42 grade 2 or above hepatic toxicity-free survival in pentostatin recipients
42 days post-transplant
Asha Pillai, MD
St. Jude Children's Research Hospital
United States: Institutional Review Board
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