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Phase 2 Belumosudil and Rituximab for Chronic Graft-Versus-Host-Disease

This study is testing two medications, belumosudil and rituximab, as a first treatment for chronic graft-versus-host-disease (cGVHD). cGVHD is a condition where donor cells attack the patient's body after a transplant. You may be able to join if you are 18 or older, have newly diagnosed cGVHD that needs treatment with medication, and meet certain health criteria (KPS score of 70% or higher). The study aims to see how many participants have their cGVHD partially or completely improve after treatment. The current status of this study is unclear, but it plans to enroll 25 participants.

Study design
This is an open-label, Phase 2 study, meaning both you and your doctors will know which treatments you are receiving. It plans to enroll 25 participants.
What's involved
You would take belumosudil by mouth daily for 24 cycles (each cycle is 28 days). You would also receive rituximab intravenously (into a vein) once a week for 4 weeks, then once every 3 months for 4 doses.
Compensation
Not stated in the trial record.
Follow-up
Your response to treatment will be measured after 2 years.

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

NCT06046248

Belumosudil and Rituximab for Primary Treatment of Chronic Graft-Versus-Host-Disease

Recruiting
PHASE2Ages 18+InterventionalTreatment
Northside Hospital, Inc.
~25 participants
Updated 2026-04-20 on ClinicalTrials.gov
What's tested:BelumosudilRituximab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of patients who achieve partial and complete responses after treatment
Measured over 2 years

Conditions

Chronic Graft Versus Host Disease

Explore related trials

Chronic Graft Versus Host Disease

NCT06046248

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Northside Hospital

    Atlanta, Georgiastudy coordinator listed

    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

  • Scott Solomon, MD · PRINCIPAL_INVESTIGATOR · BMTGA/Northside Hospital

Who to contact

Scott Solomon, MD
[email protected]
404-255-1930
Email the study team

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Eligibility criteria

Inclusion

First episode of systemic immunosuppression-requiring cGVHD, defined as classic cGVHD by the NIH consensus criteria (without features or characteristics of aGVHD)
Previously untreated, defined by having received \<10 days of corticosteroids or alternative systemic immunosuppressive agent started specifically for a new diagnosis of cGVHD
KPS \>/= 70%
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/mm#

Exclusion

Late persistent or recurrent aGVHD
Active uncontrolled infection
History of HIV infection
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
AST and/or ALT \>5x ULN or direct bilirubin \>3x ULN
Cardiac ejection fraction \<40% or history of uncontrolled cardiac arrhythmias
Has received more than one allogeneic transplant prior to the occurrence of cGVHD

What this trial measures

  • Number of patients who achieve partial and complete responses after treatment2 years