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A Study to Evaluate Vimseltinib in Adults With Active Chronic Graft-Versus-Host Disease (cGVHD)

NCT06619561 · Deciphera Pharmaceuticals, LLC
In plain English

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Official title
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
About this study
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 criteria
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 aGVHD without manifestations of cGVHD. 2. Prior use of colony-stimulating factor 1 receptor (CSF1R) inhibitor for cGVHD. 3. History or other evidence of severe illness, uncontrolled infection, or any other conditions that would make the participant unsuitable for the study. All wounds must be healed and free of infection or dehiscence. 4. History of malignancy except for: 1. Underlying malignancy for which the transplant was performed 2. Malignancy treated with curative intent and with no evidence of active disease present for more than 3 years prior to enrollment and felt to be at low risk for recurrence. 5. Malabsorption syndrome or other illness that could affect oral absorption.
Study design
Enrollment target: 48 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-11-21
Estimated completion: 2029-10
Last updated: 2025-12-15
Interventions
Drug: Vimseltinib
Primary outcomes
  • Number of Participants with Dose-Limiting Toxicities (DLTs) (Cycle 1 (28 Days))
  • Number of Participants with Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs) (Baseline to Study Completion (Estimated up to 24 months))
Sponsor
Deciphera Pharmaceuticals, LLC · industry
Contacts & investigators
ContactClinical Team · contact · clinicaltrials@deciphera.com · 888-724-3274
InvestigatorClinical Team · study_director, Deciphera Pharmaceuticals, LLC
All locations (26)
City of Hope National Medical CenterRecruiting
Duarte, California, United States
Ronald Regan UCLA Medical CenterRecruiting
Los Angeles, California, United States
University of California Irvine HealthRecruiting
Orange, California, United States
AdventHealth OrlandoRecruiting
Orlando, Florida, United States
Moffitt Cancer CenterRecruiting
Tampa, Florida, United States
Emory University Winship Cancer InstituteRecruiting
Atlanta, Georgia, United States
University of Illinois Medical Center - Hematology & OncologyRecruiting
Chicago, Illinois, United States
University of Kansas Cancer Center-WestwoodRecruiting
Westwood, Kansas, United States
University of Kentucky Markey Cancer CenterRecruiting
Lexington, Kentucky, United States
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Henry Ford Cancer InstituteRecruiting
Detroit, Michigan, United States
Washington University School of Medicine - Siteman Cancer CenterRecruiting
St Louis, Missouri, United States
Levine Cancer InstituteRecruiting
Charlotte, North Carolina, United States
Duke University HospitalRecruiting
Durham, North Carolina, United States
Oncology Hematology Care Clinical Trials, LLCRecruiting
Cincinnati, Ohio, United States
Cleveland ClinicRecruiting
Cleveland, Ohio, United States
The Ohio State University Comprehensive Cancer CenterRecruiting
Columbus, Ohio, United States
Oregon Health and Science UniversityRecruiting
Portland, Oregon, United States
UPMC Hillman Cancer CenterRecruiting
Pittsburgh, Pennsylvania, United States
Avera Cancer InstituteRecruiting
Sioux Falls, South Dakota, United States
Tristar Bone Marrow TransplantRecruiting
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer CenterRecruiting
Nashville, Tennessee, United States
St. David's South Austin Medical CenterRecruiting
Austin, Texas, United States
UT Southwestern Medical CenterRecruiting
Dallas, Texas, United States
Intermountain HealthRecruiting
Salt Lake City, Utah, United States
Virginia Commonwealth UniversityRecruiting
Richmond, Virginia, United States
A Study to Evaluate Vimseltinib in Adults With Active Chronic Graft-Versus-Host Disease (cGVHD) · TrialPath