Recruiting
Phase 2

Belumosudil & Rituximab

Sponsor:

Northside Hospital, Inc.

Code:

NCT06046248

Conditions

Chronic Graft Versus Host Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Belumosudil

Rituximab

Study Details

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

Study ID

NCT06046248

Start date

Jan 29, 2024

Status verified date

Apr, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Belumosudil Plus Rituximab

Belumosudil plus Rituximab

Interventions

Belumosudil

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

Rituximab

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

Primary outcome measure

  • Number of patients who achieve partial and complete responses after treatment [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Scott Solomon, MD

404-255-1930ssolomon@bmtga.com

Caitlin Guzowski, MBA, MHA

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

Locations

Northside Hospital

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Caitlin Guzowski, MBA, MHA

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

Principal Investigator:

Scott Solomon, MD

More Information

Sponsor

Northside Hospital, Inc.

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northside Hospital, Inc. on 2026-04-20.