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Belumosudil for Chronic Graft Versus Host Disease

This study is testing if a drug called belumosudil can help treat chronic graft versus host disease (cGVHD). cGVHD is a common problem after a stem cell transplant where the new immune cells attack your body. Belumosudil works by reducing this immune system response. You would either receive belumosudil or a placebo (an inactive substance) by mouth. The main goal is to see if belumosudil can prevent you from needing other immune-suppressing medicines for cGVHD within 12 months. This study is for adults aged 18 and older who have been diagnosed with cGVHD. The current status of this study is unclear.

Study design
This study is comparing two groups of participants: one receiving belumosudil and one receiving a placebo. It plans to enroll 82 participants.
What's involved
You would take either belumosudil or a placebo by mouth daily or twice daily for 11 cycles, with each cycle lasting 28 days. You will also have blood samples collected.
Compensation
Not stated in the trial record.
Follow-up
After your treatment ends, you will be followed up at 30 days, at 60 days if 12 cycles are completed, and then for up to 18 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05996627

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Fred Hutchinson Cancer Center
~82 participants
Updated 2026-09-17 on ClinicalTrials.gov
What's tested:BelumosudilBiospecimen CollectionElectronic Health Record ReviewPlacebo Administration

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to start of subsequent systemic immune suppressive treatment for chronic graft versus host disease (cGVHD)
Measured over From first dose of study medication to starting a new systemic immunosuppressive agent for cGVHD therapy, up to 12 months

Conditions

Chronic Graft Versus Host Disease

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Chronic Graft Versus Host Disease

NCT05996627

Where you'd take part

This study runs at 5 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washingtonstudy coordinator listed

    Recruiting

  • City of Hope

    Duarte, Californiano site contact published

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusettsno site contact published

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New Yorkno site contact published

    Recruiting

  • Moffitt Cancer Center

    Tampa, Floridano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Stephanie Lee, MD, MPH · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium

Who to contact

Gaby Desatnik
[email protected]
206-667-1356
Email the study team

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Eligibility criteria

Inclusion

At least one diagnostic or distinctive cGVHD manifestation(s), with a clinical diagnosis of cGVHD,but patients do not need to meet National Institute of Health (NIH) criteria for cGVHD
If eye involvement only, cGVHD must be confirmed on exam by an ophthalmologist or optometrist
No new immune suppressive therapy added within preceding 2 weeks prior to study enrollment for any indication
Continuation of agents previously given as either GVHD prophylaxis or acute/late acute GVHD therapy are permitted. Modification of dose of these agents for targeting of therapeutic drug levels is permitted, as are decreases in existing prednisone or prednisone equivalent dose based on routine clinical tapering practices. Increases in prednisone or prednisone equivalents are not allowed in the 2 weeks prior to enrollment
Age 18 and older
Karnofsky performance score \>= 70
Able to take oral medications
Signed informed consent
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x upper limit of normal (ULN)
Total bilirubin =\< 1.5 x ULN, unless due to Gilbert's disease
Glomerular filtration rate (estimated glomerular filtration rate \[eGFR\]) \>= 30 mL/min/1.73 m\^2
Female subjects of childbearing potential have a negative serum or urine pregnancy test at screening. Females of childbearing potential are defined as sexually mature females without prior hysterectomy or who have had any evidence of menses in the past 12 months. However, females who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anti-estrogens, or ovarian suppression
Sexually active females of childbearing potential enrolled in the study must agree to use two forms of accepted methods of contraception during the course of the study and for 3 months after their last dose of study drug. Effective birth control includes:
Intrauterine device (IUD) plus one barrier method
Stable doses of hormonal contraception for at least 3 months (eg, oral, injectable, implant, transdermal) plus one barrier method
2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gel that contain a chemical to kill sperm)
Surgical sterilization (tubal ligation)
A vasectomized partner
For male subjects who are sexually active and who are partners of females of childbearing potential: Agreement to use two forms of contraception as per above and to not donate sperm during the treatment period and for at least 3 months after the last dose of study drug
No evidence of active malignancy

Exclusion

Any systemic immune suppressive treatment for cGVHD (topical or local therapies are allowed)
Plan to start systemic immune suppressive therapy for cGVHD or increase steroid dose within 14 days after planned start of study medication
0.25 mg/kg/day or higher prednisone or prednisone equivalent dose at time of screening
History of non-compliance that in the investigator's opinion would interfere with study participation
Uncontrolled psychiatric illness
Female subject who is pregnant or breast feeding
Previous therapy with belumosudil
Known allergy/sensitivity to belumosudil or any other ROCK2 inhibitor
Treatment with another investigational agent within 28 days (or 5 half-lives, whichever is greater) of enrollment

What this trial measures

  • Time to start of subsequent systemic immune suppressive treatment for chronic graft versus host disease (cGVHD)From first dose of study medication to starting a new systemic immunosuppressive agent for cGVHD therapy, up to 12 months

    Systemic therapies include any systemic agent given for a cGVHD indication, including extracorporeal photopheresis. Will use Gray's test. Point estimates of new systemic immunosuppressive use will be obtained using cumulative incidence estimates.