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

• Sponsor: Northside Hospital, Inc. (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06046248
• Collaborator: Sanofi (Industry)
• Enrollment: 25
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 48
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Graft Versus Host Disease	Drug: Belumosudil; Drug: Rituximab	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Trial of Belumosudil and Rituximab for the Primary Treatment of Extensive Chronic Graft-versus-host Disease
• Anticipated Study Start Date: Dec 31, 2023
• Anticipated Primary Completion Date: Dec 31, 2026
• Anticipated Study Completion Date: Dec 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Belumosudil Plus Rituximab Belumosudil plus Rituximab	Drug: Belumosudil; 200mg PO QD x 24 cycles (28-day cycle); Drug: Rituximab; 375mg/m2 IV Q1 week x 4 weeks, then Q3 months x4 doses

Outcome Measures

Primary Outcome Measures

1. Number of patients who achieve partial and complete responses after treatment [2 years]

Secondary Outcome Measures

1. Length of time patients remain on corticosteroid treatment [2 years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northside Hospital	Atlanta	Georgia	United States	30342

Sponsors and Collaborators

• Northside Hospital, Inc.
• Sanofi

Investigators

• Principal Investigator: Scott Solomon, MD, BMTGA/Northside Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Northside Hospital, Inc.
• ClinicalTrials.gov Identifier: NCT06046248
• Other Study ID Numbers: NSH 1385
• First Posted: Sep 21, 2023
• Last Update Posted: Sep 25, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Bronchiolitis Obliterans Syndrome; Graft vs Host Disease; Rituximab; Belumosudil

Study Results

No Results Posted as of Sep 25, 2023