Phase II Study of Ruxolitinib to Prevent Relapse and Graft-Versus-Host Disease After Stem Cell Transplant in Adults with T-Cell Lymphoma

What this Trial Is About

Researchers are evaluating ruxolitinib as a maintenance treatment to prevent relapse and graft-versus-host disease GVHD in patients with T-cell lymphoma who have undergone stem cell transplantation. GVHD occurs when donor blood cells attack the recipients tissues after transplant. Ruxolitinib is a Janus kinase JAK inhibitor that may reduce immune responses and block cancer cell growth by targeting the JAK2 gene. This phase II trial aims to assess the drugs effects on relapse and GVHD outcomes at one year post-transplant. Starting between 35 and 120 days after stem cell transplant, participants take ruxolitinib orally twice daily for 30 days per cycle, repeating cycles every 30 days for one year unless disease progresses or side effects become unacceptable. Throughout the study, patients undergo PET-CT scans, blood sample collections, and may have bone marrow or tissue biopsies, especially if disease progresses. After completing treatment, patients are followed up at 18 and 24 months, then annually up to five years. Participants will be regularly assessed with imaging and laboratory tests to monitor disease status, immune function, and side effects. The primary outcomes include relapse rates and GVHD-free survival at one year. Secondary measures track progression-free and overall survival, incidence of acute and chronic GVHD, non-relapse mortality, adverse events, and treatment completion rates. This comprehensive monitoring helps evaluate the safety and feasibility of ruxolitinib maintenance after stem cell transplant.

Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma