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Recruiting Phase 2 NCT06046248

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

Phase 2 – studying effectiveness and dosage
Conditions: Chronic Graft Versus Host Disease

Sponsor: Northside Hospital, Inc.

trial.available_in: БГ
Overview
This is an open-label, Phase 2 study designed to evaluate the safety and efficacy of belumosudil and rituximab as primary treatment of cGVHD.
Who can participate
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
Interventions
Belumosudil
DRUG
Rituximab
DRUG
Locations 1
United States (1)
Northside Hospital
Atlanta , Georgia
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
29.01.2024
Completion date
31.12.2027
Registry ID
NCT06046248
Source
clinicaltrials.gov
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