A Phase 2 Study of Belumosudil After a Stem Cell Transplant to Prevent Graft-Versus-Host Disease

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Full Title

Phase II Open Label Prospective Nonrandomized Trial of Belumosudil for Switch-Maintenance Prophylaxis of Graft-versus-Host Disease in Allogeneic Hematopoietic Cell Transplantation

Purpose

After a stem cell transplant, some patients develop a condition called graft-versus-host disease (GVHD). This occurs when the donor’s healthy immune cells see the recipient’s normal cells as foreign and begin to attack them.

GVHD can affect many parts of the body, including the skin, liver, stomach, intestines, joints, eyes, mouth, and lungs. It can range from mild to severe and is a common cause of reduced quality of life after a transplant.

This study aims to find out whether giving belumosudil, in addition to standard immunosuppressive therapy, can reduce GVHD risk. Belumosudil is an oral medication that works by blocking specific proteins that control immune system activity. By keeping the immune system in balance, belumosudil may help prevent GVHD. It will be given around day 100 after the transplant

If you take part in this study, you will get belumosudil as well as the usual treatment to prevent GVHD. This treatment includes tacrolimus with or without cyclophosphamide chemotherapy. Your doctor will let you know whether or not you will get cyclophosphamide.

Who Can Join

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

  • Have had an allogeneic stem cell transplant (from a donor) for blood cancer and received cyclophosphamide or abatacept treatment to prevent GVHD.
  • Have received your stem cell transplant no more than 4 months before entering the study.
  • 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

25-033

Phase

Phase II (phase 2)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT07006506