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

Last updated: April 15, 2025
Sponsor: Deciphera Pharmaceuticals, LLC
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Vimseltinib

Clinical Study ID

NCT06619561
DCC-3014-02-001
  • Ages > 18
  • All Genders

Study 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

Inclusion

Inclusion Criteria:

  1. Must be allogeneic hematopoietic stem cell transplant (HSCT) recipients withmoderate to severe cGVHD requiring systemic immune suppression. a. May have persistent active GVHD (aGVHD) and chronic GVHD (cGVHD) manifestations (overlap syndrome).

  2. Participants with active cGVHD who have received and failed at least 2 prior linesof systemic therapy.

  3. Stable dose of systemic corticosteroids is permitted but not required. If beingtaken, participants should be on a stable dose of corticosteroids for at least 2weeks prior to starting study drug treatment.

  4. Adequate organ and bone marrow functions.

  5. Participants of reproductive potential agree to follow the contraceptionrequirements.

  6. Karnofsky Performance Scale (KPS) of ≥60.

Exclusion

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 otherconditions that would make the participant unsuitable for the study.

  4. History of malignancy except for:

  5. Underlying malignancy for which the transplant was performed

  6. Malignancy treated with curative intent and with no evidence of active diseasepresent for more than 3 years prior to enrollment and felt to be at low riskfor recurrence.

  7. Malabsorption syndrome or other illness that could affect oral absorption.

Study Design

Total Participants: 36
Treatment Group(s): 1
Primary Treatment: Vimseltinib
Phase: 2
Study Start date:
November 21, 2024
Estimated Completion Date:
October 31, 2029

Connect with a study center

  • City of Hope National Medical Center

    Duarte, California 91010
    United States

    Active - Recruiting

  • Ronald Regan UCLA Medical Center

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • AdventHealth Orlando

    Orlando, Florida 32804
    United States

    Active - Recruiting

  • Washington University School of Medicine - Siteman Cancer Center

    Saint Louis, Missouri 63108
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Avera Cancer Institute

    Sioux Falls, South Dakota 57105
    United States

    Active - Recruiting

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