Phase 2 Study of Ruxolitinib-Based Treatment for Acute Graft-versus-Host Disease After Bone Marrow Transplant

What this Trial Is About

Researchers are evaluating ruxolitinib-based treatments for acute graft-versus-host disease GVHD that occurs after allogeneic hematopoietic cell transplant. Acute GVHD happens when donor cells attack the recipients healthy tissues, causing symptoms like skin rash, jaundice, nausea, vomiting, and diarrhea. Standard treatment involves high-dose steroids, but responses can be insufficient or temporary, and steroids may cause serious complications. This phase 2 trial uses the Minnesota risk system to classify patients into standard or high risk groups based on their GVHD symptoms, aiming to test new ruxolitinib dosing strategies and combinations to improve outcomes. Participants are assigned to one of three treatment groups based on their risk status. Patients with standard risk receive either a lower or higher dose of oral ruxolitinib twice daily for 56 days followed by tapering doses if no progression or toxicity occurs. High risk patients receive the higher dose of ruxolitinib along with systemic corticosteroids methylprednisolone or similar starting at 2 mgkgday for at least three days before tapering. Researchers aim to identify the dose that balances effectiveness with fewer side effects such as blood or infection-related toxicities. During the study, participants are monitored for treatment response at day 28 and other outcomes including steroid-refractory GVHD at 28 days, durable response at 56 days, GVHD flares, corticosteroid use, chronic GVHD requiring steroids, overall survival, non-relapse mortality, and relapse over one year. Assessments include clinical evaluations and ongoing safety monitoring. The study lasts at least one year to observe long-term effects and survival, with careful follow-up to evaluate the impact of ruxolitinib-based therapies on acute GVHD.

MAGIC Ruxolitinib for aGVHD