A Phase 2 Study of Belumosudil in People With Chronic Graft vs. Host Disease

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Full Title

Randomized Phase II study of belumosudil vs. placebo for preemptive treatment of chronic graft vs. host disease

Purpose

After a stem cell transplant, a condition called chronic graft-versus-host disease (cGVHD) can occur. The new donor immune cells (like T cells and B cells) attack the recipient’s healthy tissues, thinking they are foreign. It usually starts around 100 days after the transplant, but it can begin earlier or later.

The purpose of this study is to see if a medication called belumosudil can help prevent early cGVHD from getting worse. Researchers also hope that early treatment with belumosudil might help people avoid corticosteroids (like prednisone). Corticosteroids are commonly used to treat cGVHD, but they can have serious side effects.

Belumosudil helps control the immune system by blocking certain proteins involved in inflammation. This may help reduce or prevent damage caused by cGVHD. Belumosudil is taken by mouth.

If you join this study, you will be randomly assigned (like flipping a coin) to get either belumosudil or a placebo. A placebo is a pill with no active medicine. This helps researchers make a fair comparison between the treatment groups.

Who Can Join

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

  • Have cGVHD.
  • Have not taken any immune-suppressing medication within 2 weeks of taking the study treatment.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Doris Ponce’s office at 646-608-3739.

Protocol

25-004

Phase

Phase II (phase 2)

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05996627