RecruitingPhase 2NCT06915246

A Study of Carmustine With and Without Ethanol in Subjects With Lymphoma

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)


Sponsor

VIVUS LLC

Enrollment

49 participants

Start Date

Mar 12, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

A phase 2 multicenter study of VI-0609 vs BiCNU in the BEAM high-intensity conditioning regimen for AHCT in subjects with lymphomas.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two versions of a conditioning regimen — carmustine alone versus carmustine with ethanol — used before a stem cell transplant in people with Hodgkin or non-Hodgkin lymphoma. The goal is to see if the combination is safer and more effective. **You may be eligible if...** - You are 18 or older with a life expectancy of at least 6 months - You have been diagnosed with Hodgkin or non-Hodgkin lymphoma and have responded (fully or partially) to treatment - You are being considered for an autologous (your own cells) stem cell transplant - You have collected enough stem cells through apheresis - Your heart and lung function meet minimum thresholds - You test negative for HIV, hepatitis C, active hepatitis B, and syphilis **You may NOT be eligible if...** - You have previously had a stem cell transplant (autologous or donor) - You have had significant radiation to critical organs - You have another active cancer or myelodysplasia - You have active lymphoma still present in your bone marrow Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVI-0609

Carmustine with Propylene Glycol

DRUGBiCNU

Carmustine with Ethanol


Locations(4)

City of Hope Phoenix

Goodyear, Arizona, United States

City of Hope National Medical Center

Duarte, California, United States

City of Hope Atlanta

Newnan, Georgia, United States

City of Hope Chicago

Zion, Illinois, United States

View Full Details on ClinicalTrials.gov

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NCT06915246


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