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

Launched by NORTHSIDE HOSPITAL, INC. · Sep 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the combined effects of two medications, belumosudil and rituximab, as a first-line treatment for a condition called chronic graft-versus-host disease (cGVHD). cGVHD can occur after a stem cell transplant when the donated cells attack the recipient's body. The trial aims to find out if this combination is safe and effective for patients who need treatment for their first episode of cGVHD.

To participate in this study, individuals must be between the ages of 65 and 74 and must have been diagnosed with cGVHD that requires systemic treatment, but they should not have received extensive prior treatment (more than 10 days of certain medications). Participants will need to meet specific health criteria to ensure they are suitable for the study. If enrolled, participants can expect close monitoring for any side effects and improvements in their condition while receiving the treatments. This trial is currently recruiting participants, and it’s important for potential volunteers to discuss their eligibility and any questions with their healthcare provider.

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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