Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06046248

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

Led by Northside Hospital, Inc. · Updated on 2026-04-20

25

Participants Needed

1

Research Sites

204 weeks

Total Duration

On this page

Sponsors

N

Northside Hospital, Inc.

Lead Sponsor

S

Sanofi

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • First episode of systemic immunosuppression-requiring chronic graft-versus-host disease defined by NIH criteria without acute GVHD features
  • Previously untreated with less than 10 days of corticosteroids or alternative systemic immunosuppressive started for new cGVHD diagnosis
  • Karnofsky Performance Status of 70% or higher
  • Adequate blood cell counts: absolute neutrophil count above 750 cells/mm3 and platelets above 30,000 cells/mm3 for at least 7 days before study entry
Not Eligible

You will not qualify if you...

  • Late persistent or recurrent acute graft-versus-host disease
  • Active uncontrolled infection
  • History of HIV infection
  • Active hepatitis B or C infection; positive hepatitis B core antibody, surface antigen, or hepatitis C antibody requires negative PCR prior to enrollment
  • Creatinine clearance less than 30 mL/min
  • Liver enzymes (AST/ALT) more than 5 times the upper limit of normal or direct bilirubin more than 3 times the upper limit
  • Cardiac ejection fraction below 40% or history of uncontrolled cardiac arrhythmias
  • More than one prior allogeneic transplant before cGVHD occurrence

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Northside Hospital

Atlanta, Georgia, United States, 30342

Actively Recruiting

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Research Team

S

Scott Solomon, MD

CONTACT

C

Caitlin Guzowski, MBA, MHA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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