drugset / Trial / NCT02528877

Ruxolitinib Phosphate, Tacrolimus and Sirolimus in Preventing Acute Graft-versus-Host Disease During Reduced Intensity Donor Hematopoietic Cell Transplant in Patients With Myelofibrosis

NCT02528877

NaSingle-groupOpen-labelSupportive care

Summary

This phase I trial studies the side effects and best dose of ruxolitinib phosphate when given together with tacrolimus and sirolimus in preventing acute graft-versus-host disease during reduced intensity donor hematopoietic cell transplant in patients with myelofibrosis. Sometimes transplanted cells from a donor can attack the normal tissue of the transplant patient called graft-versus-host disease. Ruxolitinib phosphate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It may also reduce graft-versus-host disease by reducing inflammation and immune modulation. Giving ruxolitinib phosphate together with tacrolimus and sirolimus after transplant may prevent graft-versus-host disease.

Timeline

Start
2015-11
Primary completion
2016-09
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Ruxolitinib Small molecule Oral
Background Fludarabine Small molecule Intravenous
Background Melphalan Small molecule Intravenous
Background Sirolimus Small molecule Oral
Background Tacrolimus Small molecule Intravenous