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

Phase II Trial of Belumosudil and Rituximab for the Primary Treatment of Extensive Chronic Graft-versus-host Disease

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06046248

Enrollment

Registered

2023-09-21

Start date

2024-01-29

Completion date

2027-12-31

Last updated

2025-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Graft Versus Host Disease

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.

Interventions

DRUGBelumosudil

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

DRUGRituximab

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of patients who achieve partial and complete responses after treatment	2 years

Secondary

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

Countries

United States

Contacts

Primary ContactScott Solomon, MD

ssolomon@bmtga.com404-255-1930

Backup ContactCaitlin Guzowski, MBA, MHA

caitlin.guzowski@northside.com404-851-8523

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026