A Study to Evaluate Vimseltinib in Adults With Active Chronic Graft-Versus-Host Disease (c
The purpose of this study is to determine if vimseltinib is safe, tolerable and works effectively to treat adults with active moderate to severe cGVHD. Participants will be treated with vimseltinib in 28-day treatment cycles for approximately 2 years.
| Condition(s) | Chronic Graft-Versus-Host Disease (cGVHD) |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | The purpose of this study is to determine if vimseltinib is safe, tolerable and works effectively to treat adults with active moderate to severe cGVHD. Participants will be treated with vimseltinib in 28-day treatment cycles for approximately 2 years. |
| Who can participate | Inclusion Criteria: 1. Must be allogeneic hematopoietic stem cell transplant (HSCT) recipients with moderate to severe cGVHD requiring systemic immune suppression. a. May have persistent active acute GVHD (aGVHD) and chronic GVHD (cGVHD) manifestations (overlap syndrome). 2. Participants with active cGVHD who have received and failed at least 2 prior lines of systemic therapy. 3. Stable dose of systemic corticosteroids is permitted but not required. If being taken, participants should be on a stable dose of corticosteroids for at least 2 weeks prior to starting study drug treatment. 4. Adequate organ and bone marrow functions. 5. Participants of reproductive potential agree to follow the contraception requirements. 6. Karnofsky Performance Scale (KPS) of ≥60. Exclusion Criteria: 1. Has aGV |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Deciphera Pharmaceuticals, LLC |
| Locations | Duarte, California, United States; Los Angeles, California, United States; Orange, California, United States; Orlando, Florida, United States; Tampa, Florida, United States; Atlanta, Georgia, United States (+20 more sites) |
| Start date | 2024-11-21 |
| NCT ID | NCT06619561 |
| Official listing | https://clinicaltrials.gov/study/NCT06619561 |