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

NCT06619561 | Recruiting Phase 2 FDA Drug

• 1 other identifier: DCC-3014-02-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 26

Brief 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.

Conditions

Chronic Graft-Versus-Host Disease (cGVHD)

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Dose-Limiting Toxicities (DLTs)

  DLTs assessed for each dose level.

  Cycle 1 (28 Days)

• Number of Participants with Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs)

  AEs and SAEs assessed for each dose level.

  Baseline to Study Completion (Estimated up to 24 months)

Secondary Outcomes (5)

• Objective Response Rate (ORR)

  Baseline up to Cycle 7 Day 1 (Cycle = 28 days)

• Duration of Response (DOR)

  First CR or PR until PD or Death due to Any Cause (Estimated up to 24 months)

• Organ-Specific Response

  Baseline up to Cycle 7 Day 1 (Cycle = 28 days)

• Failure-Free Survival (FFS)

  Baseline to, whichever occurs first of, PD, Addition of Systemic Immune Suppressive Therapy, or Death due to Any Cause (Estimated up to 24 months)

• Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax)

  Estimated up to 24 months

Study Arms (1)

Vimseltinib

EXPERIMENTAL

Escalating doses of vimseltinib in 28 day cycles.

Drug: Vimseltinib

Interventions

Vimseltinib DRUG

Administered orally

Also known as: DCC-3014

Vimseltinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Participants with active cGVHD who have received and failed at least 2 prior lines of systemic therapy.
• 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.
• Adequate organ and bone marrow functions.
• Participants of reproductive potential agree to follow the contraception requirements.
• Karnofsky Performance Scale (KPS) of ≥60.

You may not qualify if:

• Has aGVHD without manifestations of cGVHD.
• Prior use of colony-stimulating factor 1 receptor (CSF1R) inhibitor for cGVHD.
• 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.
• History of malignancy except for:
• Underlying malignancy for which the transplant was performed
• 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.
• Malabsorption syndrome or other illness that could affect oral absorption.

Sponsors & Collaborators

• Deciphera Pharmaceuticals, LLC: lead

Study Sites (26)

City of Hope National Medical Center

Duarte, California, 91010, United States

RECRUITING

Ronald Regan UCLA Medical Center

Los Angeles, California, 90095, United States

RECRUITING

University of California Irvine Health

Orange, California, 92868-3201, United States

RECRUITING

AdventHealth Orlando

Orlando, Florida, 32804, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

University of Illinois Medical Center - Hematology & Oncology

Chicago, Illinois, 60612, United States

RECRUITING

University of Kansas Cancer Center-Westwood

Westwood, Kansas, 66205, United States

RECRUITING

University of Kentucky Markey Cancer Center

Lexington, Kentucky, 40536, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Henry Ford Cancer Institute

Detroit, Michigan, 48202, United States

RECRUITING

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri, 63108, United States

RECRUITING

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

Duke University Hospital

Durham, North Carolina, 27705, United States

RECRUITING

Oncology Hematology Care Clinical Trials, LLC

Cincinnati, Ohio, 45242, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

RECRUITING

Tristar Bone Marrow Transplant

Nashville, Tennessee, 37203, United States

RECRUITING

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

RECRUITING

St. David's South Austin Medical Center

Austin, Texas, 78704, United States

RECRUITING

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Intermountain Health

Salt Lake City, Utah, 84143, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome; Graft vs Host Disease; Immune System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Sclerosis; Fibrosis; Liver Diseases

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Digestive System Diseases

Study Officials

• Clinical Team

  Deciphera Pharmaceuticals, LLC

  STUDY DIRECTOR

Central Study Contacts

Clinical Team

CONTACT

888-724-3274; clinicaltrials@deciphera.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 1, 2024
• Study Start: November 21, 2024
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

US (26)