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

In the U.S.

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.