RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-11-21

Study Completion:2029-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06619561

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Must be allogeneic hematopoietic stem cell transplant (HSCT) recipients with moderate to severe cGVHD requiring systemic immune suppression. 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.	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. 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.

Inclusion Criteria

Exclusion Criteria

1. Must be allogeneic hematopoietic stem cell transplant (HSCT) recipients with moderate to severe cGVHD requiring systemic immune suppression.
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.

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.
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.

Contacts and Locations

Study Contact

Clinical Team

CONTACT

785-830-2100

clinicaltrials@deciphera.com

Principal Investigator

Clinical Team

STUDY_DIRECTOR

Deciphera Pharmaceuticals, LLC

Study Locations (Sites)

City of Hope National Medical Center

Duarte, California, 91010

United States

Avera Cancer Institute

Sioux Falls, South Dakota, 57105

United States

Collaborators and Investigators

Sponsor: Deciphera Pharmaceuticals, LLC

Clinical Team, STUDY_DIRECTOR, Deciphera Pharmaceuticals, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-21

Study Completion Date2029-10

Study Record Updates