At a glance
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Phase II Trial of Tacrolimus and Rapamycin vs. Tacrolimus and Methotrexate as GVHD Prophylaxis After Allogeneic Peripheral Blood Hematopoietic Cell Transplantation
In Brief
A Phase 2 clinical trial evaluating Tacrolimus (TAC), Methotrexate (MTX), and 1 other intervention for Acute Graft Versus Host Disease. Completed, enrolled 74 participants across 1 site.
Detailed Summary
The purpose of this research is to compare the effectiveness of Tacrolimus and Rapamycin to Tacrolimus and Methotrexate in the prevention of severe graft-versus-host-disease. Graft-versus-host-disease (GVHD) is a risk associated with allogeneic hematopoietic cell transplants (HCT). An allogeneic hematopoietic cell transplant is a transplant using bone marrow and blood cells that come from someone other than the patient (a donor).
Study Details
Timeline
Interventions
Tacrolimus: administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.
Methotrexate: administered on day 1 at dose of 15 mg/m\^2, and a dose of 10 mg/m\^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance.
Rapamycin: initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily.