Actively Recruiting
Randomized Phase II Study Comparing Belumosudil to Placebo for Preemptive Treatment of Chronic Graft Versus Host Disease
Led by Fred Hutchinson Cancer Center · Updated on 2026-06-04
82
Participants Needed
5
Research Sites
30 weeks
Total Duration
On this page
Sponsors
F
Fred Hutchinson Cancer Center
Lead Sponsor
S
Sanofi
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
Belumosudil for the Pre-emptive Treatment of Patients With Chronic Graft Versus Host Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years and older
- Clinical diagnosis of chronic graft versus host disease (cGVHD), including at least one diagnostic or distinctive manifestation
- For eye-only involvement, cGVHD must be confirmed by an ophthalmologist or optometrist
- No new immune suppressive therapy added within 2 weeks prior to enrollment
- Continuation or dose modification of some prior immune therapies allowed, but no increases in prednisone or equivalent in 2 weeks before enrollment
- Karnofsky performance score of 70 or higher
- Able to take oral medications
- Signed informed consent
- Liver function tests (ALT and AST) less than or equal to 3 times the upper limit of normal
- Total bilirubin less than or equal to 1.5 times upper limit of normal unless due to Gilbert's disease
- Estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m2
- Female participants of childbearing potential must have a negative pregnancy test at screening and agree to use two forms of contraception during the study and for 3 months after last dose
- Male participants with partners of childbearing potential must agree to use two forms of contraception and avoid sperm donation during treatment and for 3 months after last dose
- No evidence of active malignancy
You will not qualify if you...
- Any systemic immune suppressive treatment for cGVHD at screening (topical or local treatments allowed)
- Planning to start systemic immune suppressive therapy for cGVHD or increase steroid dose within 14 days after starting study medication
- Prednisone or equivalent dose of 0.25 mg/kg/day or higher at screening
- History of non-compliance interfering with study participation
- Uncontrolled psychiatric illness
- Pregnant or breastfeeding females
- Previous therapy with belumosudil
- Known allergy or sensitivity to belumosudil or any ROCK2 inhibitor
- Treatment with another investigational agent within 28 days or 5 half-lives before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Up to 12 cycles of 28 days each, including tapering cycle
Participants receive belumosudil or placebo orally daily or twice daily in 28-day cycles for up to 11 cycles, followed by one tapering cycle if tolerated without disease progression or unacceptable toxicity. Blood samples are collected during this period.
Daily oral medication with regular visits for treatment monitoring
Duration - Up to 18 months after treatment ends
Participants are monitored after treatment completion with visits at 30 days and 60 days after the last cycle, then up to 18 months for ongoing safety and outcomes.
Visits at 30 days, 60 days, and periodic follow-ups up to 18 months
Trial Site Locations
Total: 5 locations
1
City of Hope
Duarte, California, United States, 91010
Not Yet Recruiting
2
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
5
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
G
Gaby Desatnik
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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