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

RecruitingPhase 2Ages 18 Years - anyAllDeciphera Pharmaceuticals, LLC
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ60. 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.
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What it tests

  • Vimseltinib
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Where

26 sites
City of Hope National Medical Center
Duarte, United States
Ronald Regan UCLA Medical Center
Los Angeles, United States
University of California Irvine Health
Orange, United States
AdventHealth Orlando
Orlando, United States
Moffitt Cancer Center
Tampa, United States
Emory University Winship Cancer Institute
Atlanta, United States
University of Illinois Medical Center - Hematology & Oncology
Chicago, United States
University of Kansas Cancer Center-Westwood
Westwood, United States

โ€ฆand 18 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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