Using belumosudil and rituximab to treat chronic graft-versus-host disease
Phase II Trial of Belumosudil and Rituximab for the Primary Treatment of Extensive Chronic Graft-versus-host Disease
This study is testing if a new combination of belumosudil and rituximab can help people with their first episode of chronic graft-versus-host disease feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northside Hospital, Inc. Academic / other |
| Drugs / interventions | rituximab |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT06046248 on ClinicalTrials.gov |
What this trial studies
This open-label Phase 2 study aims to evaluate the safety and efficacy of belumosudil combined with rituximab as a primary treatment for chronic graft-versus-host disease (cGVHD). The study focuses on patients experiencing their first episode of cGVHD requiring systemic immunosuppression, ensuring they have not previously received extensive treatment. Participants will be monitored for their response to the treatment and any potential side effects. The goal is to establish a new therapeutic approach for managing this challenging condition.
Who should consider this trial
Good fit: Ideal candidates are those experiencing their first episode of systemic immunosuppression-requiring cGVHD who have not received significant prior treatment.
Not a fit: Patients with late persistent or recurrent acute graft-versus-host disease or those with active uncontrolled infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from chronic graft-versus-host disease.
How similar studies have performed: While this approach is being evaluated in this specific context, similar studies using targeted therapies for cGVHD have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Atlanta, Georgia
- Northside Hospital — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Scott Solomon, MD — BMTGA/Northside Hospital
- Study coordinator: Scott Solomon, MD
- Email: ssolomon@bmtga.com
- Phone: 404-255-1930
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.