Belumosudil and Rituximab for Primary Treatment of Chronic Graft-Versus-Host-Disease
Part of paid clinical trials in Atlanta, Georgia.
- Sponsor
- Northside Hospital, Inc.
- Study ID
- NCT06046248
- Phase
- PHASE2
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Belumosudil — DRUG200mg PO QD x 24 cycles (28-day cycle)
- Rituximab — DRUG375mg/m2 IV Q1 week x 4 weeks, then Q3 months x4 doses
Study Details
This is an open-label, Phase 2 study designed to evaluate the safety and efficacy of belumosudil and rituximab as primary treatment of cGVHD.
Key Dates
- Start date
- Jan 29, 2024
- Status verified
- Apr 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 25 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Belumosudil Plus RituximabBelumosudil plus Rituximab
Primary Outcome Measure
Number of patients who achieve partial and complete responses after treatment [ Time Frame: 2 years ]
Central Contacts
- Scott Solomon, MD404-255-1930
- Caitlin Guzowski, MBA, MHA404-851-8523
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Northside Hospital | Atlanta | Georgia | 30342 | H. Kent Holland, MD (SUB_INVESTIGATOR) Asad Bashey, MD (SUB_INVESTIGATOR) Lawrence E Morris, MD (SUB_INVESTIGATOR) Scott Solomon, MD (PRINCIPAL_INVESTIGATOR) Melhem Solh, MD (SUB_INVESTIGATOR) Lizamarie Bachier-Rodriguez, MD (SUB_INVESTIGATOR) |
Find similar trials in Atlanta, GA
By research site
Related Studies
- A Long-term Extension Study of PCI-32765 (Ibrutinib)PHASE3 · Recruiting · Janssen Research & Development, LLC · Duarte, California
- Predicting the Quality of Response to Specific Treatments in Patients With cGVHD, PQRST StudyRecruiting · Fred Hutchinson Cancer Center · Gainesville, Florida
- BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP)PHASE2 · Recruiting · Dana-Farber Cancer Institute · Stanford, California
- Belumosudil for the Pre-emptive Treatment of Patients With Chronic Graft Versus Host DiseasePHASE2 · Recruiting · Fred Hutchinson Cancer Center · Duarte, California