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

NCT06046248 | Recruiting Phase 2 FDA Drug

• 1 other identifier: NSH 1385
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Graft Versus Host Disease

Outcome Measures

Primary Outcomes (1)

• Number of patients who achieve partial and complete responses after treatment

  2 years

Secondary Outcomes (2)

• Length of time patients remain on corticosteroid treatment

  2 years

• Number of patients who had treatment-related adverse events using CTCAE v5

  2 years

Study Arms (1)

Belumosudil Plus Rituximab

EXPERIMENTAL

Belumosudil plus Rituximab

Drug: Belumosudil; Drug: Rituximab

Interventions

Belumosudil DRUG

200mg PO QD x 24 cycles (28-day cycle)

Belumosudil Plus Rituximab

Rituximab DRUG

375mg/m2 IV Q1 week x 4 weeks, then Q3 months x4 doses

Belumosudil Plus Rituximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Northside Hospital, Inc.: lead
• Sanofi: collaborator

Study Sites (1)

Northside Hospital

Atlanta, Georgia, 30342, United States

RECRUITING

Related Publications (39)

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MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Interventions

belumosudil; Rituximab

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Scott Solomon, MD

  BMTGA/Northside Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Scott Solomon, MD

CONTACT

404-255-1930; ssolomon@bmtga.com

Caitlin Guzowski, MBA, MHA

CONTACT

404-851-8523; caitlin.guzowski@northside.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 21, 2023
• Study Start: January 29, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)