Phase II Study Comparing Belumosudil to Placebo for Early Treatment of Chronic Graft Versus Host Disease in Adults

What this Trial Is About

Researchers are evaluating the effects of belumosudil compared to a placebo in adults with chronic graft versus host disease cGVHD, a serious complication after stem cell transplantation that can affect multiple organs. This phase II trial aims to see if belumosudil, a drug that selectively inhibits ROCK2 to reduce immune system overactivity, can better manage cGVHD and delay the need for additional immune-suppressing treatments. The study is led by Fred Hutchinson Cancer Center and includes patients diagnosed with cGVHD, including those with eye involvement confirmed by an eye specialist. Participants are randomly assigned to one of two groups. One group receives belumosudil orally once or twice daily depending on other medications they take, for 28 days per cycle, repeating for 11 cycles plus one tapering cycle if no disease progression or unacceptable side effects occur. The other group receives a matching placebo on the same schedule. Blood samples are collected during the study to monitor effects. After treatment, participants are followed up at 30 days, 60 days if 12 cycles are completed, and then for up to 18 months. During the study, participants will have evaluations to measure the time until they need additional immune suppressive therapy for cGVHD, overall survival, event-free survival, and relapse rates over 12 months or until study end. The trial includes regular blood tests and clinical assessments to monitor safety and effectiveness. Participants must be able to take oral medications and meet health criteria including liver and kidney function tests. The study excludes those with recent or current systemic immune suppressive treatment or other disqualifying conditions.

Belumosudil for the Pre-emptive Treatment of Patients With Chronic Graft Versus Host Disease