Actively Recruiting
A Randomized Phase 2 Study of Carmustine Formulated With and Without Ethanol as Part of BEAM Chemotherapy Conditioning for Subjects With Lymphoma Undergoing Autologous Hematopoietic Cell Transplantation (AHCT)
Led by VIVUS LLC · Updated on 2026-03-27
49
Participants Needed
4
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a phase 2 multicenter clinical trial to compare two forms of carmustine—VI-0609 (carmustine with propylene glycol) and BiCNU (carmustine with ethanol)—as 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female adults 18 years of age or older with a life expectancy of 6 months or more
- Karnofsky performance status of 70% or higher
- Histologically confirmed Hodgkin lymphoma or Non-Hodgkin lymphoma
- Candidate for autologous hematopoietic cell transplant consolidation therapy
- Achieved a complete or partial response to prior treatment
- Completed collection of at least 2.0 x 10^6 CD34 cells/kg of autologous hematopoietic progenitor cells by apheresis
- Recovery from non-hematologic toxicities of salvage cytoreductive chemotherapy to grade 2 or less
- Clinical laboratory and organ function criteria met, including LVEF 50% or higher, FEV1 greater than 65% of predicted, and DLCO 50% or higher of predicted
- Seronegative for HIV Ag/Ab combo, hepatitis C virus, active hepatitis B virus, and syphilis
You will not qualify if you...
- Prior high-dose chemotherapy with autologous stem cell transplant or prior allogeneic transplantation
- Significant prior external beam radiation to a critical organ that is dose-limiting
- Use of any other investigational medication or device, or concurrent biological, chemotherapy, or radiation therapy
- Myelodysplasia or any active malignancy other than Hodgkin or Non-Hodgkin lymphoma, or less than 5 years remission from any other prior malignancy
- Cytogenetic abnormalities in bone marrow associated with or predictive of myelodysplasia
- Persistent marrow involvement over 10% with Hodgkin or Non-Hodgkin lymphoma after salvage cytoreductive therapy and before stem cell mobilization
- Insufficient bone marrow harvest to reach adequate cell dose for transplant
- Active hepatitis B or C infection or positive hepatitis B surface antigen
- Positive HIV antibody
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days post-transplant
Participants receive chemotherapy conditioning with Carmustine formulated with or without Ethanol as part of BEAM chemotherapy before autologous hematopoietic cell transplantation.
Multiple visits during chemotherapy conditioning and transplantation period
Duration - 30 days post-transplant
Participants are monitored for infusion-related and other toxicities up to 30 days after transplantation.
Visits within 24 hours post infusion and through Day 30 post-transplant
Trial Site Locations
Total: 4 locations
1
City of Hope Phoenix
Goodyear, Arizona, United States, 85338
Actively Recruiting
2
City of Hope National Medical Center
Duarte, California, United States, 91010
Actively Recruiting
3
City of Hope Atlanta
Newnan, Georgia, United States, 30265
Actively Recruiting
4
City of Hope Chicago
Zion, Illinois, United States, 60099
Actively Recruiting
Research Team
V
VIVUS Clinical
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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