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

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.

Conditions

Chronic Graft-Versus-Host Disease (cGVHD)

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Chronic Graft-Versus-Host Disease (cGVHD)
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope National Medical Center, Duarte, California, United States, 91010

Sioux Falls

Avera Cancer Institute, Sioux Falls, South Dakota, United States, 57105

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Deciphera Pharmaceuticals, LLC,

Clinical Team, STUDY_DIRECTOR, Deciphera Pharmaceuticals, LLC

Study Record Dates

2029-10