A Study of Carmustine With and Without Ethanol in Subjects With Lymphoma
Part of paid clinical trials in Goodyear, Arizona.
- Sponsor
- VIVUS LLC
- Study ID
- NCT06915246
- Phase
- PHASE2
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- VI-0609 — DRUGCarmustine with Propylene Glycol
- BiCNU — DRUGCarmustine with Ethanol
Study Details
A phase 2 multicenter study of VI-0609 vs BiCNU in the BEAM high-intensity conditioning regimen for AHCT in subjects with lymphomas.
Key Dates
- Start date
- Mar 12, 2025
- Status verified
- Mar 2026
- Primary completion
- Mar 31, 2027
- Completion
- Apr 30, 2027
Study Design
- Enrollment
- 49 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: VI-0609VI-0609 (Carmustine with Propylene Glycol)
- Active Comparator: BiCNUBiCNU (Carmustine with Ethanol)
Primary Outcome Measure
Evaluation of infusion-related toxicities [ Time Frame: Within 24 hours post infusion ]
Central Contacts
- VIVUS Clinical+1-888-998-4887
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| City of Hope Phoenix | Goodyear | Arizona | 85338 | |
| City of Hope National Medical Center | Duarte | California | 91010 | |
| City of Hope Atlanta | Newnan | Georgia | 30265 | |
| City of Hope Chicago | Zion | Illinois | 60099 |
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