Conditions: Acute Graft Versus Host Disease
Keywords: Acute Graft Versus Host Disease (aGVHD) GVHD graft-versus-host disease tacrolimus sirolimus methotrexate combination therapy GVHD prophylaxis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 74
Healthy volunteers: no

Brief 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).

Detailed description:
All drugs used in this study have been used in the prevention of graft-versus-host-disease after allogeneic hematopoietic cell transplant. Tacrolimus and Methotrexate used in combination are currently used as standard of care in the prevention of graft-versus-host-disease after allogeneic hematopoietic cell transplant. Tacrolimus and Rapamycin is a newer combination we are testing to see if it would be better than Tacrolimus and Methotrexate.

Arms:
arm 1: Tacrolimus: beginning 3 days before transplant and given for at least 50 days.

Rapamycin: given the day before transplant and continued daily for at least one year. arm 2: Tacrolimus: beginning 3 days before transplant and given for at least 50 days.

Methotrexate: given on days 1, 3, 6 and 11, after transplant.

Interventions: intervention 1: Tacrolimus (TAC) intervention 2: Methotrexate (MTX) intervention 3: Rapamycin (RAPA)
Intervention descriptions: intervention 1: Tacrolimus: administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3. intervention 2: 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. intervention 3: Rapamycin: initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily.

Protocol document: