Belumosudil and Rituximab for Primary Treatment of Chronic Graft-Versus-Host-Disease
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 |
---|---|---|
Phase 2 |
Study Design
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
- Number of patients who achieve partial and complete responses after treatment [2 years]
Secondary Outcome Measures
- Length of time patients remain on corticosteroid treatment [2 years]
- Number of patients who had treatment-related adverse events using CTCAE v5 [2 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
First episode of systemic immunosuppression-requiring cGVHD, defined as classic cGVHD by the NIH consensus criteria (without features or characteristics of aGVHD)
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Previously untreated, defined by having received <10 days of corticosteroids or alternative systemic immunosuppressive agent started specifically for a new diagnosis of cGVHD
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KPS >/= 70%
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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:
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Late persistent or recurrent aGVHD
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Active uncontrolled infection
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History of HIV infection
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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.
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Calculated CrCl <30mL/min
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AST and/or ALT >5x ULN or direct bilirubin >3x ULN
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Cardiac ejection fraction <40% or history of uncontrolled cardiac arrhythmias
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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.- NSH 1385