Belumosudil and Rituximab for Primary Treatment of Chronic Graft-Versus-Host-Disease
NCT ID: NCT06046248
Last Updated: 2025-10-30
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE2
Total Enrollment
25 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-01-29
Study Completion Date
2027-12-31
Brief Summary
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This is an open-label, Phase 2 study designed to evaluate the safety and efficacy of belumosudil and rituximab as primary treatment of cGVHD.
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Detailed Description
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Conditions
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Chronic Graft Versus Host Disease
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Belumosudil Plus Rituximab
Belumosudil plus Rituximab
Group Type
EXPERIMENTAL
Belumosudil
Intervention Type
DRUG
200mg PO QD x 24 cycles (28-day cycle)
Rituximab
Intervention Type
DRUG
375mg/m2 IV Q1 week x 4 weeks, then Q3 months x4 doses
Interventions
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Belumosudil
200mg PO QD x 24 cycles (28-day cycle)
Intervention Type
DRUG
Rituximab
375mg/m2 IV Q1 week x 4 weeks, then Q3 months x4 doses
Intervention Type
DRUG
Eligibility Criteria
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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#
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Sanofi
INDUSTRY
Sponsor Role
collaborator
Northside Hospital, Inc.
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Scott Solomon, MD
Role: PRINCIPAL_INVESTIGATOR
BMTGA/Northside Hospital
Locations
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Northside Hospital
Atlanta, Georgia, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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NSH 1385
Identifier Type: -
Identifier Source: org_study_id
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