Belumosudil for the Pre-emptive Treatment of Patients With Chronic Graft Versus Host Disease
NCT ID: NCT05996627
Last Updated: 2025-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
82 participants
INTERVENTIONAL
2023-12-06
2027-12-31
Brief Summary
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Detailed Description
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ARM I: Patients receive belumosudil orally (PO) daily (QD) or twice daily (BID) if taken with strong CYP3A inducers or proton pump inhibitors for days 1 through 28 of each cycle. Cycles repeat every 28 days for a total of 11 cycles, followed by one cycle of tapering prior to discontinuation, in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive a placebo PO QD or BID if taken with strong CYP3A inducers or proton pump inhibitors for days 1 through 28 of each cycle. Cycles repeat every 28 days for a total of 11 cycles, followed by one cycle of tapering prior to discontinuation, in the absence of disease progression or unacceptable toxicity.
Patients undergo blood sample collection on study.
After completion of study treatment, patients are followed up at 30 days, at 60 days if 12 cycles are completed, and then up to 18 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm I (Belumosudil)
Patients receive belumosudil PO QD or BID if taken with strong CYP3A inducers or proton pump inhibitors for days 1 through 28 of each cycle. Cycles repeat every 28 days for a total of 11 cycles, followed by one cycle of tapering prior to discontinuation, in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection on study.
Belumosudil
Given PO
Biospecimen Collection
Undergo blood sample collection
Electronic Health Record Review
Ancillary studies
Arm II (Placebo)
Patients receive a placebo PO QD or BID if taken with strong CYP3A inducers or proton pump inhibitors for days 1 through 28 of each cycle. Cycles repeat every 28 days for a total of 11 cycles, followed by one cycle of tapering prior to discontinuation, in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection on study.
Biospecimen Collection
Undergo blood sample collection
Electronic Health Record Review
Ancillary studies
Placebo Administration
Given PO
Interventions
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Belumosudil
Given PO
Biospecimen Collection
Undergo blood sample collection
Electronic Health Record Review
Ancillary studies
Placebo Administration
Given PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Stephanie Lee, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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Moffitt Cancer Center
Tampa, Florida, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2023-05293
Identifier Type: REGISTRY
Identifier Source: secondary_id
RG1123523
Identifier Type: OTHER
Identifier Source: secondary_id
20163
Identifier Type: OTHER
Identifier Source: secondary_id
RG1123523
Identifier Type: -
Identifier Source: org_study_id
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