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

NCT ID: NCT06619561

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-21

Study Completion Date

2029-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Graft-Versus-Host Disease (cGVHD)

Keywords

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Allogeneic hematopoietic stem cell transplant (HSCT) Graft-Versus-Host Disease GVHD cGVHD Graft versus host disease Immune System Diseases Organizing Pneumonia Bronchiolitis Obliterans Bronchiolitis Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Bronchiolitis Obliterans Syndrome Graft vs Host Disease Sclerosis Fibrosis Hematopoietic stem cell transplantation Liver diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vimseltinib

Escalating doses of vimseltinib in 28 day cycles.

Group Type EXPERIMENTAL

Vimseltinib

Intervention Type DRUG

Administered orally

Interventions

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Vimseltinib

Administered orally

Intervention Type DRUG

Other Intervention Names

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DCC-3014

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deciphera Pharmaceuticals, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Team

Role: STUDY_DIRECTOR

Deciphera Pharmaceuticals, LLC

Locations

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City of Hope National Medical Center

Duarte, California, United States

Site Status RECRUITING

Ronald Regan UCLA Medical Center

Los Angeles, California, United States

Site Status RECRUITING

University of California Irvine Health

Orange, California, United States

Site Status RECRUITING

AdventHealth Orlando

Orlando, Florida, United States

Site Status RECRUITING

Moffitt Cancer Center

Tampa, Florida, United States

Site Status RECRUITING

Emory University Winship Cancer Institute

Atlanta, Georgia, United States

Site Status RECRUITING

University of Illinois Medical Center - Hematology & Oncology

Chicago, Illinois, United States

Site Status RECRUITING

University of Kansas Cancer Center-Westwood

Westwood, Kansas, United States

Site Status RECRUITING

University of Kentucky Markey Cancer Center

Lexington, Kentucky, United States

Site Status RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status RECRUITING

Henry Ford Cancer Institute

Detroit, Michigan, United States

Site Status RECRUITING

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri, United States

Site Status RECRUITING

Levine Cancer Institute

Charlotte, North Carolina, United States

Site Status RECRUITING

Duke University Hospital

Durham, North Carolina, United States

Site Status RECRUITING

Oncology Hematology Care Clinical Trials, LLC

Cincinnati, Ohio, United States

Site Status RECRUITING

Cleveland Clinic

Cleveland, Ohio, United States

Site Status RECRUITING

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status RECRUITING

Oregon Health and Science University

Portland, Oregon, United States

Site Status RECRUITING

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Site Status RECRUITING

Tristar Bone Marrow Transplant

Nashville, Tennessee, United States

Site Status RECRUITING

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Site Status RECRUITING

St. David's South Austin Medical Center

Austin, Texas, United States

Site Status RECRUITING

Intermountain Health

Salt Lake City, Utah, United States

Site Status RECRUITING

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Clinical Team

Role: CONTACT

Phone: 888-724-3274

Email: [email protected]

Other Identifiers

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DCC-3014-02-001

Identifier Type: -

Identifier Source: org_study_id