NCT06915246 · VIVUS LLC
A Study of Carmustine With and Without Ethanol in Subjects With Lymphoma
What this study is about
A phase 2 conducted at multiple hospitals study of VI-0609 vs BiCNU in the BEAM high-intensity conditioning regimen for AHCT in subjects with lymphomas.
View original scientific description
A phase 2 multicenter study of VI-0609 vs BiCNU in the BEAM high-intensity conditioning regimen for AHCT in subjects with lymphomas.
Interventions
DRUG
VI-0609
Carmustine with Propylene Glycol
DRUG
BiCNU
Carmustine with Ethanol
Primary outcome measures
Evaluation of infusion-related toxicities
Time frame: Within 24 hours post infusion
Evaluation of unacceptable toxicities
Time frame: From start of BEAM through Day 30 post-AHCT
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male and female adults ≥ 18 years of age with a life expectancy ≥ 6 months;
- Karnofsky performance status ≥ 70%;
- Histologically confirmed Hodgkin lymphoma or Non-Hodgkin lymphoma;
- Candidate for AHCT consolidation therapy as assessed by their treating physician;
- Achieved a complete or partial response;
- Completed collection of at least 2.0 x 10\^6 CD34 cells/kg of autologous hematopoietic progenitor cells (HPCs) by apheresis;
- Recovery from non-hematologic toxicities of salvage cytoreductive chemotherapy to ≤ grade 2;
- Clinical laboratory and organ function criteria meeting study ranges/limits LVEF ≥ 50%; FEV1 \> 65% of predicted measurement, DLCO ≥ 50% of predicted;
- Seronegative for HIV Ag/Ab combo, HCV, active HBV, and syphilis
Exclusion criteria
- Prior high-dose chemotherapy with autologous stem cell transplant, or prior allogeneic transplantation;
- Significant prior external beam dose-limiting radiation to a critical organ based on review of t
Where
- Goodyear, Arizona
- Duarte, California
- Newnan, Georgia
- Zion, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 27, 2026 · Source of record for eligibility and locations