Actively Recruiting
Belumosudil for the Pre-emptive Treatment of Patients With Chronic Graft Versus Host Disease
Led by Fred Hutchinson Cancer Center · Updated on 2026-02-17
82
Participants Needed
4
Research Sites
260 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
This phase II trial compares the effect of belumosudil to a placebo in treating patients with chronic graft versus host disease. Chronic graft versus host disease remains a major complication of stem cell transplantation and can involve multiple organ systems. Belumosudil is a ROCK2 selective inhibitor that works to reduce the immune system response causing the chronic graft versus host disease. Giving belumosudil may better treat patients with chronic graft versus host disease and prevent the need for starting additional immune suppressive medications.
CONDITIONS
Official 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...
- At least one diagnostic or distinctive chronic graft versus host disease (cGVHD) manifestation with a clinical diagnosis of cGVHD
- If only eye involvement, cGVHD must be confirmed by an ophthalmologist or optometrist
- No new immune suppressive therapy added within 2 weeks before enrollment for any reason
- Continuation of previous immune suppressive agents for GVHD prophylaxis or therapy allowed with dose adjustments for therapeutic levels or tapering
- No increases in prednisone or prednisone equivalents in the 2 weeks before enrollment
- Age 18 years or older
- Karnofsky performance score of 70 or higher
- Able to take medications by mouth
- Signed informed consent
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels at or below 3 times the upper limit of normal
- Total bilirubin at or below 1.5 times the upper limit of normal unless due to Gilbert's disease
- Estimated glomerular filtration rate (eGFR) of 30 mL/min/1.73 m2 or higher
- Female participants of childbearing potential must have a negative pregnancy test at screening
- Sexually active females of childbearing potential must use two forms of contraception during the study and for 3 months after last dose
- Sexually active males with female partners of childbearing potential must 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 therapies allowed)
- Plan to start systemic immune suppressive therapy 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 that may interfere with study participation
- Uncontrolled psychiatric illness
- Female participants who are pregnant or breastfeeding
- Previous treatment with belumosudil
- Known allergy or sensitivity to belumosudil or any ROCK2 inhibitor
- Treatment with another investigational drug within 28 days or 5 half-lives before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
4
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
G
Gaby Desatnik
CONTACT
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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