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ROCK2 selective inhibitor
Belumosudil for Graft-versus-Host Disease
Phase 2
Recruiting
Led By Stephanie Lee, MD, MPH
Research Sponsored by Fred Hutchinson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No evidence of active malignancy
Karnofsky performance score >= 70
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months or end of study
Awards & highlights
Study Summary
This trial tests a new drug to treat chronic graft versus host disease, which affects multiple organs. Belumosudil reduces the immune system response which causes the disease, potentially avoiding the need for other immune-suppressing drugs.
Who is the study for?
This trial is for adults with chronic graft versus host disease who can take oral meds, have a good performance status (Karnofsky score >= 70), and normal organ function. Women of childbearing potential must use two forms of contraception and not be pregnant or breastfeeding. Participants cannot have used belumosudil before, be on high-dose steroids, or plan to start new immune suppressive treatments.Check my eligibility
What is being tested?
The study compares the effects of Belumosudil, a drug that may reduce immune response in chronic graft versus host disease, against a placebo. It aims to see if Belumosudil can better treat patients without needing additional immune suppressants.See study design
What are the potential side effects?
Potential side effects of Belumosudil are not detailed here but could include reactions related to the suppression of the immune system since it's designed to reduce the body's defense mechanisms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I do not have any signs of active cancer.
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I am able to care for myself but may not be able to do active work.
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I am 18 years old or older.
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I haven't started any new immune-suppressing treatments in the last 2 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months or end of study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months or end of study
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to start of subsequent systemic immune suppressive treatment for chronic graft versus host disease (cGVHD)
Secondary outcome measures
Event-free survival
Overall survival
Rate of relapse
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (Belumosudil)Experimental Treatment3 Interventions
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.
Group II: Arm II (Placebo)Placebo Group3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1700
Belumosudil
2018
Completed Phase 2
~320
Find a Location
Who is running the clinical trial?
SanofiIndustry Sponsor
2,164 Previous Clinical Trials
3,514,898 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
557 Previous Clinical Trials
1,343,433 Total Patients Enrolled
1 Trials studying Graft-versus-Host Disease
10 Patients Enrolled for Graft-versus-Host Disease
Stephanie Lee, MD, MPHPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
1 Previous Clinical Trials
911 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with belumosudil before.Your kidneys are working well, with a filtration rate of at least 30 milliliters per minute per 1.73 square meters of body surface area.I am currently pregnant or breastfeeding.I do not have any signs of active cancer.I am taking 0.25 mg/kg/day or more of prednisone.I am able to care for myself but may not be able to do active work.I am a woman who could become pregnant and have a negative pregnancy test.I have been diagnosed with chronic GVHD without meeting NIH criteria.I am continuing treatments for GVHD without increasing my prednisone dose in the last 2 weeks.I agree to use two effective birth control methods during and 3 months after the study.Your total bilirubin level should be less than or equal to 1.5 times the upper limit of normal.I am allergic to belumosudil or similar medications.I am 18 years old or older.I haven't started any new immune-suppressing treatments in the last 2 weeks.You have a mental illness that is not under control.If you only have eye problems, a specialist needs to confirm that you have cGVHD during an eye exam.I can take pills by mouth.Your liver enzymes (ALT and AST) are not more than three times the normal level.I am not on any immune-suppressing drugs for chronic GVHD, only topical treatments.I plan to begin or increase immune-suppressing therapy soon.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (Belumosudil)
- Group 2: Arm II (Placebo)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities for subjects to participate in this clinical trial?
"According to information found on the clinicaltrials.gov website, this trial is no longer searching for participants as it was last updated in August 10th 2023. Fortunately, there are currently 176 other studies that are actively enrolling patients right now."
Answered by AI
Has Belumosudil been authorized by the FDA?
"Our analysis has yielded a safety score of 2 for Arm I (Belumosudil), as this is a Phase II trial with supporting data on its safety but not efficacy."
Answered by AI
How extensively is this investigation being conducted?
"This trial is being conducted at Moffitt Cancer Center in Tampa, Mass General Cancer Center located in New york City, and Memorial Sloan Kettering Cancer Center situated in Seattle. In addition to these 3 sites, there are 5 other medical centres participating as well."
Answered by AI
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