At a glance
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Phase I/II Study of Pentostatin Combined With Tacrolimus and Mini-Methotrexate for GVHD Prevention After Matched-Unrelated Donor Blood and Marrow Transplantation
In Brief
A Phase 2 clinical trial evaluating Pentostatin, Tacrolimus, and 1 other intervention for Leukemia and Lymphoma. Completed, enrolled 150 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Given intravenously on days +8, +15, +22 and +30 post transplant: Group 2 - Pentostatin 0.5 mg/m\^2 Group 3 - Pentostatin 1 mg/m\^2 Group 4 - Pentostatin 1.5 mg/m\^2 Group 5 - Pentostatin 2 mg/m\^2
Given intravenously from day -2, and will be switched to oral dosing when tolerated.
Given intravenously on days +1, +3, and +6 at the dose of 5 mg/m2.