A Phase 1-2 Study of Belumosudil in Children and Adolescents With Chronic Graft-Versus-Host Disease

Full Title

An Open-label, Phase 1/2, Multicenter Study of Belumosudil in Children Aged 1 to 18 Years Requiring Systemic Treatment for Active Moderate-to-severe Chronic Graft Versus Host Disease (cGVHD)

Purpose

Chronic graft-versus-host disease (cGVHD) is a condition in which healthy transplanted stem cells attack the recipient’s healthy cells. cGVHD most often happens more than 100 days after a stem cell transplant, but it can happen at any time.

Belumosudil is an oral medicine (taken by mouth) already used to treat adolescent and adult patients with cGVHD. Researchers want to find the best dose of belumosudil for children with cGVHD and learn how well it treats cGVHD in younger patients.

Eligible patients have cGVHD that is resistant to or has returned after at least 2 lines of systemic therapy. Systemic therapy is a type of treatment that works throughout the whole body.

Belumosudil blocks proteins involved in cGVHD. It helps control the immune system, reducing its ability to attack the body after a transplant and decreasing tissue damage.

Who Can Join

To join this study, there are a few conditions. Your child must:

  • Have cGVHD that is resistant to or has returned after at least 2 lines of systemic therapy.  
  • Be age 1-17.

Contact

For more information about this study or to see if your child can join, please call 833-MSK-KIDS.

Protocol

25-194

Phase

Phase I/II (phases 1 and 2 combined)

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT07116031