Evaluating Vimseltinib for Chronic Graft-Versus-Host Disease in Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the safety, tolerability, and effectiveness of vimseltinib in treating adults with active moderate to severe chronic graft-versus-host disease (cGVHD). Participants will receive vimseltinib in 28-day treatment cycles over a period of approximately two years. The study focuses on individuals who have previously undergone allogeneic hematopoietic stem cell transplantation and have not responded to at least two prior systemic therapies. The goal is to improve treatment outcomes for patients suffering from this challenging condition.

Why it matters

Who can join: the full rules

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.

Where it's running

• City of Hope National Medical Center
  Duarte, California, United States Recruiting
• Ronald Regan UCLA Medical Center
  Los Angeles, California, United States Recruiting
• University of California Irvine Health
  Orange, California, United States Recruiting
• AdventHealth Orlando
  Orlando, Florida, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• Emory University Winship Cancer Institute
  Atlanta, Georgia, United States Recruiting

Study contacts

• Study coordinator: Clinical Team
• Email: clinicaltrials@deciphera.com
• Phone: 888-724-3274

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Comparing Ruxolitinib and Prednisone for treating chronic GVHD

  This study is testing whether Ruxolitinib works better than Prednisone for adults with chronic graft-versus-host disease who need treatment.

  Recruiting at 6 sites Phase 2 H. Lee Moffitt Cancer Center and Research Institute · Miami, Florida and 5 other locations · NCT06660355

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.