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Recruiting

NCT Number: NCT06046248

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

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

Recruiting

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Belumosudil

Drug

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

Rituximab

Drug

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

Primary outcomes

  1. Number of patients who achieve partial and complete responses after treatment

    Time frame: 2 years

Secondary outcomes

  1. Length of time patients remain on corticosteroid treatment

    Time frame: 2 years

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

    Time frame: 2 years

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Northside Hospital, Inc.

Other

Collaborators

  • Sanofi

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 21, 2023
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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