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Suspended
NCT06046248
Belumosudil and Rituximab for Primary Treatment of Chronic Graft-Versus-Host-Disease
Conditions: Chronic Graft Versus Host Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 25
Sponsor: Northside Hospital, Inc.
Location: Northside Hospital Atlanta Georgia
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.
Eligibility 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)
* Previously untreated, defined by having received \/= 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 \5x ULN or direct bilirubin \>3x ULN
* Cardiac ejection fraction \
Source: ClinicalTrials.gov (NCT06046248). StuddyBuddy aggregates publicly available trial information.