Clinical Trial

Biomarker-Guided Ruxolitinib for the Prevention of Chronic Graft Versus Host Disease After Allogeneic Hematopoietic Cell Transplantation

Recruiting Phase 1
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Summary
This phase I trial studies how well biomarker-guided ruxolitinib works for the prevention of chronic graft versus host disease (GVHD) in patients that have undergone allogeneic hematopoietic cell transplant (HCT). Allogeneic HCT is the most effective therapy for patients with high-risk blood and bone marrow malignancies. GVHD is a disease caused when cells from a donated stem cell graft attack the normal tissue of the transplant patient. Symptoms include jaundice, skin rash or blisters, a dry mouth, or dry eyes. In chronic GVHD (cGVHD), symptoms occur more than three months after transplantation. Despite significant advances in how allogeneic HCTs are conducted, cGHVD remains a major limitation to the long-term success of the transplant and can impact patients' quality of life post-transplant. Checking GVHD biomarkers in patients' blood after allogeneic HCT may help doctors predict how likely the patient is to develop cGVHD. This information can be used to help guide patients with high levels to receive cGVHD preventative therapy with ruxolitinib. Ruxolitinib works by blocking some of the enzymes that are needed for the development of cGVHD, which may be an effective way to prevent cGVHD in patients with high levels of GVHD biomarkers.
Protocol Amendment History 2 changes
notable Primary completion moved earlier: 2029-06-22 -> 2028-06-22 2026-04-21
minor Completion moved earlier: 2029-06-22 -> 2028-06-22 2026-04-21
Trial Details
NCT Number NCT07025538
Lead Sponsor City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Conditions Hematopoietic and Lymphatic System Neoplasm
Enrollment 42 participants
Start Date 2026-04-29
Primary Completion 2028-06-22 (estimated)
Study Completion 2028-06-22 (estimated)
Updated on ClinicalTrials.gov 2026-07-13