NCT06619561 A Study to Evaluate Vimseltinib in Adults With Active Chronic Graft-Versus-Host Disease (cGVHD)
| NCT ID | NCT06619561 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Deciphera Pharmaceuticals, LLC |
| Condition | Chronic Graft-Versus-Host Disease (cGVHD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2024-11-21 |
| Primary Completion | 2029-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 48 participants in total. It began in 2024-11-21 with a primary completion date of 2029-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Clinical Team
STUDY DIRECTOR
Deciphera Pharmaceuticals, LLC
Frequently Asked Questions
Who can join the NCT06619561 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Graft-Versus-Host Disease (cGVHD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06619561 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06619561 currently recruiting?
Yes, NCT06619561 is actively recruiting participants. Contact the research team at clinicaltrials@deciphera.com for enrollment information.
Where is the NCT06619561 trial being conducted?
This trial is being conducted at Duarte, United States, Los Angeles, United States, Orange, United States, Orlando, United States and 11 additional locations.
Who is sponsoring the NCT06619561 clinical trial?
NCT06619561 is sponsored by Deciphera Pharmaceuticals, LLC. The principal investigator is Clinical Team at Deciphera Pharmaceuticals, LLC. The trial plans to enroll 48 participants.