Study Comparing Ruxolitinib and Standard Treatment to Prevent Graft-Versus-Host Disease After Stem Cell Transplant in Adults With Blood Cancers

What this Trial Is About

Researchers are evaluating two different approaches to prevent chronic graft-versus-host disease GVHD in people with blood cancers who are receiving allogeneic hematopoietic stem cell transplantation allo-HCT. The study aims to determine which prevention method is more effective at reducing chronic GVHD up to one year after transplantation. This is a phase 2 clinical trial focused on prevention in this patient population. Participants will receive one of two regimens an experimental group receiving an intermediate dose of post-transplant cyclophosphamide PTCY combined with tacrolimus, mycophenolate mofetil MMF, and the drug ruxolitinib taken twice daily or a standard group receiving a full dose of PTCY with tacrolimus and MMF. Tacrolimus dosing starts on day 5 after transplant, with tapering schedules depending on the group. MMF is given from day 5 to day 35. The study compares these two approaches for preventing chronic GVHD. During the study, participants will be monitored up to one year after transplant to assess chronic GVHD-free survival as the primary outcome. Researchers will also track the incidence of moderate to severe infections over one year. Safety, treatment adherence, and clinical responses will be evaluated through routine medical visits and assessments during this period. The total participation time spans the transplant procedure and one year of follow-up.

A Study of Ruxolitinib for Preventing Graft-Versus-Host Disease in People With a Hematologic Malignancy Who Will Receive a Stem Cell Transplant