NCT06619561 · Deciphera Pharmaceuticals, LLC
A Study to Evaluate Vimseltinib in Adults With Active Chronic Graft-Versus-Host Disease (cGVHD)
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Vimseltinib
Administered orally
Primary outcome measures
Number of Participants with Dose-Limiting Toxicities (DLTs)
Time frame: Cycle 1 (28 Days)
DLTs assessed for each dose level.
Number of Participants with Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs)
Time frame: Baseline to Study Completion (Estimated up to 24 months)
AEs and SAEs assessed for each dose level.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Must be allogeneic hematopoietic stem cell transplant (HSCT) recipients with moderate to severe cGVHD requiring systemic immune suppression. a. May have persistent active 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
- 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 ot
Where
- Duarte, California
- Los Angeles, California
- Orange, California
- Orlando, Florida
- Tampa, Florida
- Atlanta, Georgia
- Chicago, Illinois
- Westwood, Kansas
- Lexington, Kentucky
- Boston, Massachusetts
- Detroit, Michigan
- St Louis, Missouri
And 13 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 15, 2025 · Source of record for eligibility and locations