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

Recruiting now · Phase 2

Conditions studied: Chronic Graft Versus Host Disease

In brief

This is an open-label, Phase 2 study designed to evaluate the safety and efficacy of belumosudil and rituximab as primary treatment of cGVHD.

Key facts

Study ID

NCT06046248

Run by

Northside Hospital, Inc.

People needed

25

Starts

2024-01-29

Expected to finish

2027-12-31

Last updated by the study team

2026-04-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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#

You may not qualify if…

• 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

Where it is running

• Northside Hospital — Atlanta, Georgia, United States (enrolling)

Full record on ClinicalTrials.gov

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