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

RecruitingPhase 2

Sponsor: Northside Hospital, Inc.

Conditions: Chronic Graft Versus Host Disease

Interventions: Belumosudil, Rituximab

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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 \<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

Locations (1)

Atlanta, Georgia, United States