Overview

Phase I/II Study of Pentostatin Combined With Tacrolimus and Mini-Methotrexate for GVHD Prevention After MUD BMT

Status:
Completed
Trial end date:
2009-11-01
Target enrollment:
Participant gender:
Summary
Primary Objective: 1. To determine efficacy of escalating doses of pentostatin in combination with tacrolimus and methotrexate for the prevention of acute graft-versus-host disease (GVHD) in the context of unrelated donor and one antigen mismatched related donor transplantation. Secondary Objectives: 1. To determine safety of escalating doses of pentostatin in combination with tacrolimus and methotrexate. 2. To reduce the incidence of acute GVHD following transplants with unrelated donor to 40%. 3. To document blood levels of tacrolimus when combined with pentostatin.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborators:
Astex Pharmaceuticals
Astex Pharmaceuticals, Inc.
Treatments:
Methotrexate
Pentostatin
Tacrolimus