Biomarker-Guided Ruxolitinib for the Prevention of Chronic Graft Versus Host Disease After
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 malignancie
| Condition(s) | Hematopoietic and Lymphatic System Neoplasm |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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-transpl |
| Who can participate | Inclusion Criteria: * PRE-SCREENING: Documented informed consent of the participant and/or legally authorized representative * Assent, when appropriate, will be obtained per institutional guidelines * PRE-SCREENING: Agreement to allow the use of archival tissue from diagnostic tumor biopsies * If unavailable, exceptions may be granted with study principal investigator (PI) approval * PRE-SCREENING: Age: ≥ 18 years * PRE-SCREENING: Karnofsky performance status ≥ 80 * PRE-SCREENING: Patients must have undergone allogeneic hematopoietic cell transplantation with peripheral blood stem cells as graft source. Note: Patients receiving manipulated graft are not included * PRE-SCREENING: Morphologic remission per day +30 bone marrow * PRE-SCREENING: Any conditioning regimen (myeloablative, reduce i |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | City of Hope Medical Center |
| Locations | Duarte, California, United States |
| Start date | 2026-06-01 |
| NCT ID | NCT07025538 |
| Official listing | https://clinicaltrials.gov/study/NCT07025538 |