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NCT06619561PHASE2Recruiting

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

Deciphera Pharmaceuticals, LLC

Start Date

11/21/2024

Completion Date

10/1/2029

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

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Vimseltinib

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Conditions

Chronic Graft-Versus-Host Disease (cGVHD)

Locations

City of Hope National Medical Center

Duarte, California 91010

United States

Ronald Regan UCLA Medical Center

Los Angeles, California 90095

United States

University of California Irvine Health

Orange, California 92868-3201

United States

AdventHealth Orlando

Orlando, Florida 32804

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

Emory University Winship Cancer Institute

Atlanta, Georgia 30322

United States

University of Illinois Medical Center - Hematology & Oncology

Chicago, Illinois 60612

United States

University of Kansas Cancer Center-Westwood

Westwood, Kansas 66205

United States

University of Kentucky Markey Cancer Center

Lexington, Kentucky 40536

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215

United States

Henry Ford Cancer Institute

Detroit, Michigan 48202

United States

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri 63108

United States

Levine Cancer Institute

Charlotte, North Carolina 28204

United States

Duke University Hospital

Durham, North Carolina 27705

United States

Oncology Hematology Care Clinical Trials, LLC

Cincinnati, Ohio 45242

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio 43210

United States

Oregon Health and Science University

Portland, Oregon 97239

United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania 15232

United States

Avera Cancer Institute

Sioux Falls, South Dakota 57105

United States

Tristar Bone Marrow Transplant

Nashville, Tennessee 37203

United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee 37232

United States

St. David's South Austin Medical Center

Austin, Texas 78704

United States

UT Southwestern Medical Center

Dallas, Texas 75390

United States

Intermountain Health

Salt Lake City, Utah 84143

United States

Virginia Commonwealth University

Richmond, Virginia 23298

United States