Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Gary J. Schiller, MD (ucla)
Headshot of Gary J. Schiller
Gary J. Schiller

Description

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.

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

Keywords

Chronic Graft-Versus-Host Disease (cGVHD), 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, Vimseltinib

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

  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.

Locations

  • Ronald Regan UCLA Medical Center accepting new patients
    Los Angeles California 90095 United States
  • City of Hope National Medical Center accepting new patients
    Duarte California 91010 United States

Lead Scientist at University of California Health

  • Gary J. Schiller, MD (ucla)
    Professor-in-Residence, Medicine. Authored (or co-authored) 163 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Deciphera Pharmaceuticals, LLC
ID
NCT06619561
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 36 study participants
Last Updated