A Study to Evaluate Vimseltinib in Adults With Active Chronic Graft-Versus-Host Disease (cGVHD)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDeciphera Pharmaceuticals, LLC
About this trial
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
Qualifiers
Must be allogeneic hematopoietic stem cell transplant (HSCT) recipients with moderate to severe cGVHD requiring systemic immune suppression.
Participants with active cGVHD who have received and failed at least 2 prior lines of systemic therapy.
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.
Adequate organ and bone marrow functions.
Disqualifiers
Has aGVHD without manifestations of cGVHD.
Prior use of colony-stimulating factor 1 receptor (CSF1R) inhibitor for cGVHD.
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.
Underlying malignancy for which the transplant was performed
Trial design
Treatments tested in this trial
- Vimseltinib
Treatment groups
48 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov