NCT01188798

Methotrexate or Pentostatin for Graft-versus-host Disease Prophylaxis in Risk-adapted Allogeneic Bone Marrow Transplantation for Hematologic Malignancies

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: St. Jude Children's Research Hospital · Academic / Other
• Sex: All
• Age: 18 Months – 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Lymphoblastic Leukemia
• Acute Myelocytic Leukemia
• Chronic Myelocytic Leukemia
• Hodgkin's Disease
• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	Methotrexate	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.
DRUG	Pentostatin	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.

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2010-08-25
• Last updated: 2013-03-21
• Results posted: 2013-03-14

Locations

1 site across 1 country: United States