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

Chronic Graft Versus Host Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06046248
• Other study ID #: NSH 1385
• Status: Recruiting
• Phase: Phase 2
• Start date: January 29, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2024
• Source: Northside Hospital, Inc.
• Contact: Scott Solomon, MD
• Phone: 404-255-1930
• Email: ssolomon[@]bmtga.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bronchiolitis Obliterans Syndrome
• Chronic Graft Versus Host Disease
• Graft vs Host Disease

Intervention

Drug:
• Belumosudil
200mg PO QD x 24 cycles (28-day cycle)
• Rituximab
375mg/m2 IV Q1 week x 4 weeks, then Q3 months x4 doses

Locations

Country	Name	City	State
United States	Northside Hospital	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Northside Hospital, Inc.	Sanofi

Country where clinical trial is conducted

United States, 

References & Publications (39)

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* Note: There are 39 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who achieve partial and complete responses after treatment		2 years
Secondary	Length of time patients remain on corticosteroid treatment		2 years
Secondary	Number of patients who had treatment-related adverse events using CTCAE v5		2 years