Actively Recruiting
Phase 2 Study Comparing Carmustine Formulated With and Without Ethanol in BEAM Chemotherapy for Adults With Lymphoma Undergoing Stem Cell Transplant
Led by VIVUS LLC · Updated on 2026-03-27
49
Participants Needed
4
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are conducting a phase 2 multicenter clinical trial to compare two forms of carmustineVI-0609 carmustine with propylene glycol and BiCNU carmustine with ethanolas part of the BEAM high-intensity chemotherapy conditioning regimen for autologous hematopoietic cell transplantation AHCT in adults with Hodgkin or Non-Hodgkin lymphoma. The study aims to evaluate infusion-related and other toxicities associated with these formulations in patients undergoing AHCT. Participants will be randomly assigned to receive either VI-0609 or BiCNU as part of their BEAM chemotherapy regimen before AHCT. This comparison will help assess differences in infusion-related adverse effects within 24 hours post-infusion and evaluate unacceptable toxicities from the start of BEAM chemotherapy through 30 days after transplantation. The trial does not involve masking or blinding. During the study, participants will be closely monitored for infusion-related toxicities and other adverse effects through various clinical and laboratory assessments. The primary outcomes focus on the safety of the treatments within specified timeframes post-infusion and transplantation. Participants will be followed through the transplantation process and up to 30 days afterward to measure these outcomes. The total duration of involvement depends on the treatment schedule and post-transplant monitoring periods.
CONDITIONS
Brief Title
A Study of Carmustine With and Without Ethanol in Subjects With Lymphoma
Research Team
V
VIVUS Clinical
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