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

Northside Hospital, Inc.

Status and phase

Enrolling

Phase 2

Conditions

Chronic Graft Versus Host Disease

Treatments

Drug: Rituximab

Drug: Belumosudil

Study type

Interventional

Funder types

Other

Industry

Identifiers

NSH 1385

Details and patient eligibility

About

This is an open-label, Phase 2 study designed to evaluate the safety and efficacy of belumosudil and rituximab as primary treatment of cGVHD.

Enrollment

25 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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