Conditions: Graft-versus-host Disease Hematopoietic Stem Cell Transplantation
Keywords: Graft-versus-host disease GVHD Maraviroc non-myeloablative allogeneic stem-cell transplantation Hematopoietic stem cell transplantation
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 38
Healthy volunteers: no

Brief summary:
This study investigates the effectiveness and safety of Maraviroc (an oral medication given twice daily given in addition to the standard GVHD prophylaxis) in preventing Graft versus Host Disease (GVHD) in patients undergoing non-myeloablative allogeneic stem-cell transplantation (SCT). Subjects will receive Maraviroc bid (in addition to standard GVHD prophylaxis) beginning after the last dose of the chemotherapy conditioning regimen until day 30 after stem-cell infusion.

Detailed description:

Arms:
arm 1: 150mg twice daily arm 2: 300mg twice daily arm 3: 300mg twice daily

Interventions: intervention 1: Maraviroc 150 MG intervention 2: Maraviroc 300 mg intervention 3: Maraviroc 300 mg Phase II
Intervention descriptions: intervention 1: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion. intervention 2: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion. intervention 3: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.

Protocol document: