NCT06046248 Belumosudil and Rituximab for Primary Treatment of Chronic Graft-Versus-Host-Disease
| NCT ID | NCT06046248 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Northside Hospital, Inc. |
| Condition | Chronic Graft Versus Host Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2024-01-29 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 25 participants in total. It began in 2024-01-29 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 \<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
Contact & Investigator
Scott Solomon, MD
PRINCIPAL INVESTIGATOR
BMTGA/Northside Hospital
Frequently Asked Questions
Who can join the NCT06046248 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Graft Versus Host Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06046248 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06046248 currently recruiting?
Yes, NCT06046248 is actively recruiting participants. Contact the research team at ssolomon@bmtga.com for enrollment information.
Where is the NCT06046248 trial being conducted?
This trial is being conducted at Atlanta, United States.
Who is sponsoring the NCT06046248 clinical trial?
NCT06046248 is sponsored by Northside Hospital, Inc.. The principal investigator is Scott Solomon, MD at BMTGA/Northside Hospital. The trial plans to enroll 25 participants.