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A drug, belumosudil,  to treat chronic graft-versus-host disease (GVHD) in children and adults who are ethnically diverse 

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12 and older

Phase 2

5 Locations

NCT05567406

Clinical Trial Goal


To find out if belumosudil is safe and works well to treat chronic GVHD in children and adults who are ethnically diverse

You may be able to join this trial if you:


  • Are 12 years old or older
  • Have chronic GVHD
  • Identify with one of the following ethnicities:
    • American Indian or Alaska Native
    • Black or African American
    • Native Hawaiian or Other Pacific Islander
  • Have not been treated for chronic GVHD with the drugs ibrutinib or ruxolitinib. Your doctor can tell you this
  • Do not have post-transplant lymphoproliferative disease (PTLD)
  • Your cancer has not come back (relapsed)
  • Agree to have other standard tests done to see if you can be in the clinical trial 

Trial Details


Belumosudil is drug that blocks ROCK2 in certain cells. 

You’ll get treatment in cycles that last 1 month. In each cycle, you'll get:
  • Belumosudil – A pill that you take by mouth 1-2 times each day

You may continue treatment for as long as the clinical trial doctors think it’s best for your health. You'll have blood tests or biopsies to see how well the treatment is working. The clinical trial doctors will check your health for up to 4 years.

The Food and Drug Administration (FDA) has approved belumosudil to treat chronic GVHD. Studying it specifically in ethnically diverse patients is new and unproven.

Contacts


Trial Transparency email recommended (Toll free for US & Canada), 800-633-1610, Contact-US@sanofi.com

Locations

Nicklaus Children's Hospital - Miami - Southwest 62nd Avenue- Site Number : 129RECRUITING

Miami, Florida

University of Maryland School of Medicine - Baltimore- Site Number : 128RECRUITING

Baltimore, Maryland

Dana-Farber Cancer Institute- Site Number : 004RECRUITING

Boston, Massachusetts

Massachusetts General Hospital- Site Number : 002RECRUITING

Boston, Massachusetts

Westchester Medical Center- Site Number : 130RECRUITING

Valhalla, New York

ClinicalTrials.gov record


NCT05567406. First posted on 10/5/22

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