RECRUITINGPhase 2INTERVENTIONAL
A Study to Evaluate Vimseltinib in Adults With Active Chronic Graft-Versus-Host Disease (cGVHD)
A Phase 2, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, PK, and Efficacy of Vimseltinib in Adults With Active Chronic GVHD After Failure of Prior Systemic Therapy
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.
Who May Be Eligible (Plain English)
Who May Qualify:
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.
Who Should NOT Join This Trial:
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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Vimseltinib
Administered orally
Locations (20)
City of Hope National Medical Center
Duarte, California, United States
Ronald Regan UCLA Medical Center
Los Angeles, California, United States
University of California Irvine Health
Orange, California, United States
AdventHealth Orlando
Orlando, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Emory University Winship Cancer Institute
Atlanta, Georgia, United States
University of Illinois Medical Center - Hematology & Oncology
Chicago, Illinois, United States
University of Kansas Cancer Center-Westwood
Westwood, Kansas, United States
University of Kentucky Markey Cancer Center
Lexington, Kentucky, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Cancer Institute
Detroit, Michigan, United States
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Duke University Hospital
Durham, North Carolina, United States
Oncology Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States