A Phase 2, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, PK, and Efficacy of Vimseltinib in Adults With Active Chronic GVHD After Failure of Prior Systemic Therapy
Deciphera Pharmaceuticals, LLC
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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. Ad…
Interventions
- DrugVimseltinib
Administered orally
Locations (26)
- City of Hope National Medical CenterDuarte, California
- Ronald Regan UCLA Medical CenterLos Angeles, California
- University of California Irvine HealthOrange, California
- AdventHealth OrlandoOrlando, Florida
- Moffitt Cancer CenterTampa, Florida
- Emory University Winship Cancer InstituteAtlanta, Georgia