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

Recruiting now · Phase 2

Conditions studied: Chronic Graft-Versus-Host Disease (cGVHD)

In brief

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.

Key facts

Study ID

NCT06619561

Run by

Deciphera Pharmaceuticals, LLC

People needed

48

Starts

2024-11-21

Expected to finish

2029-10-01

Last updated by the study team

2025-12-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).
• 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.
• Participants of reproductive potential agree to follow the contraception requirements.
• Karnofsky Performance Scale (KPS) of ≥60.

You may not qualify if…

• 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.
• History of malignancy except for:
• Underlying malignancy for which the transplant was performed
• 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.
• Malabsorption syndrome or other illness that could affect oral absorption.

Where it is running

• City of Hope National Medical Center — Duarte, California, United States (enrolling)
• Ronald Regan UCLA Medical Center — Los Angeles, California, United States (enrolling)
• University of California Irvine Health — Orange, California, United States (enrolling)
• AdventHealth Orlando — Orlando, Florida, United States (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• Emory University Winship Cancer Institute — Atlanta, Georgia, United States (enrolling)
• University of Illinois Medical Center - Hematology & Oncology — Chicago, Illinois, United States (enrolling)
• University of Kansas Cancer Center-Westwood — Westwood, Kansas, United States (enrolling)
• University of Kentucky Markey Cancer Center — Lexington, Kentucky, United States (enrolling)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Henry Ford Cancer Institute — Detroit, Michigan, United States (enrolling)
• Washington University School of Medicine - Siteman Cancer Center — St Louis, Missouri, United States (enrolling)
• Levine Cancer Institute — Charlotte, North Carolina, United States (enrolling)
• Duke University Hospital — Durham, North Carolina, United States (enrolling)
• Oncology Hematology Care Clinical Trials, LLC — Cincinnati, Ohio, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (enrolling)
• Oregon Health and Science University — Portland, Oregon, United States (enrolling)
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (enrolling)
• Avera Cancer Institute — Sioux Falls, South Dakota, United States (enrolling)
• Tristar Bone Marrow Transplant — Nashville, Tennessee, United States (enrolling)
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States (enrolling)
• St. David's South Austin Medical Center — Austin, Texas, United States (enrolling)
• UT Southwestern Medical Center — Dallas, Texas, United States (enrolling)
• Intermountain Health — Salt Lake City, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

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