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Kinase Inhibitor

Belumosudil + Rituximab for Graft-versus-Host Disease

Phase 2
Recruiting
Led By Scott Solomon, MD
Research Sponsored by Northside Hospital, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate hematologic function independent of platelet transfusion and G-CSF for at least 7 days prior to study entry: ANC >750 cells/mm3; Platelets >30,000 cells/mm3
KPS >/= 70%
Must not have
Active HBV or HCV infection. Subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative PCR result before enrollment. Those who are PCR positive will be excluded.
Calculated CrCl <30mL/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial studies a drug combo to treat a serious condition that affects bone marrow transplant patients.

Who is the study for?
This trial is for individuals with a new diagnosis of chronic Graft-Versus-Host Disease (cGVHD) who haven't been treated yet, or have had less than 10 days of corticosteroids. Participants must be in good physical condition (KPS >/= 70%) and have adequate blood cell counts without recent transfusions. People with HIV, active hepatitis B or C, severe liver issues, poor kidney function, uncontrolled infections or heart problems cannot join.
What is being tested?
The study is testing the combination of two drugs—Belumosudil and Rituximab—as a primary treatment for cGVHD. It's an open-label Phase 2 trial which means everyone knows what treatment they're getting and it's fairly early in the testing process to see if it works well and is safe.
What are the potential side effects?
While specific side effects are not listed here, Belumosudil may cause digestive issues, headaches, muscle pains; Rituximab can lead to infusion reactions like fever/chills, infections due to low white blood cells count, heart problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood counts are within the required range without transfusions for a week.
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I am mostly able to care for myself and carry out daily activities.
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I have chronic GVHD needing systemic treatment for the first time.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have an active hepatitis B or C infection.
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My kidney function is low, with a filtration rate under 30 mL/min.
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I have ongoing or returning graft-versus-host disease.
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I have had more than one transplant from a donor before my graft-versus-host disease.
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I have an infection that is not under control.
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My heart's pumping ability is weak or I have irregular heartbeats that aren't controlled.
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I have a history of HIV infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Belumosudil Plus RituximabExperimental Treatment2 Interventions
Belumosudil plus Rituximab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~2990
Belumosudil
2018
Completed Phase 2
~320

Find a Location

Who is running the clinical trial?

Northside Hospital, Inc.Lead Sponsor
24 Previous Clinical Trials
1,043 Total Patients Enrolled
SanofiIndustry Sponsor
2,209 Previous Clinical Trials
4,039,741 Total Patients Enrolled
Scott Solomon, MDPrincipal InvestigatorBMTGA/Northside Hospital
6 Previous Clinical Trials
20,204 Total Patients Enrolled
~17 spots leftby Dec 2026
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