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

Phase 2

Recruiting

• Conditions: Chronic Graft Versus Host Disease
• Interventions: Drug: Belumosudil; Drug: Rituximab

• Registration Number: NCT06046248
• Lead Sponsor: Northside Hospital, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-14
• Study First Submitted QC: 2023-09-14
• Study First Posted: 2023-09-21
• Study Start: 2024-01-29
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-15
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Belumosudil Plus Rituximab	Rituximab	Belumosudil plus Rituximab
Belumosudil Plus Rituximab	Belumosudil	Belumosudil plus Rituximab

Primary Outcome Measures

Name	Time	Method
Number of patients who achieve partial and complete responses after treatment	2 years

Secondary Outcome Measures

Name	Time	Method
Length of time patients remain on corticosteroid treatment	2 years
Number of patients who had treatment-related adverse events using CTCAE v5	2 years

Trial Locations

Locations (1)

Northside Hospital; 🇺🇸 Atlanta, Georgia, United States