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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

Must not have

Previous therapy with belumosudil

Female subject who is pregnant or breast feeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months or end of 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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with belumosudil before.

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I am currently pregnant or breastfeeding.

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I am taking 0.25 mg/kg/day or more of prednisone.

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I am allergic to belumosudil or similar medications.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months or end of study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to start of subsequent systemic immune suppressive treatment for chronic graft versus host disease (cGVHD)

Secondary study objectives

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

Belumosudil

2018

Completed Phase 2

~320

Biospecimen Collection

2004

Completed Phase 3

~2030