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

March 25, 2026 updated by: VIVUS LLC

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)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

49

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Goodyear, Arizona, United States, 85338
        • Recruiting
        • City of Hope Phoenix
        • Contact:
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope National Medical Center
        • Contact:
    • Georgia
      • Newnan, Georgia, United States, 30265
        • Recruiting
        • City of Hope Atlanta
        • Contact:
    • Illinois
      • Zion, Illinois, United States, 60099
        • Recruiting
        • City of Hope Chicago
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 the prior radiation treatment records;
  • Use of any other investigational medication or device, or concurrent biological, chemotherapy, or radiation therapy;
  • Myelodysplasia or any active malignancy other than HL or NHL, or < 5 years remission from any other prior malignancy;
  • Any cytogenetic abnormality in the bone marrow that is known to be associated with or predictive of myelodysplasia;
  • Persistent marrow involvement (>10%) with HL or NHL after salvage cytoreductive therapy and before stem cell mobilization;
  • Not having sufficient bone marrow harvest to reach adequate cell dose for transplant;
  • Active hepatitis B or C viral infection or HBsAg positive;
  • Positive HIV antibody;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VI-0609
VI-0609 (Carmustine with Propylene Glycol)
Drug: VI-0609
Carmustine with Propylene Glycol
Active Comparator: BiCNU
BiCNU (Carmustine with Ethanol)
Drug: BiCNU
Carmustine with Ethanol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of infusion-related toxicities
Time Frame: Within 24 hours post infusion
Within 24 hours post infusion
Evaluation of unacceptable toxicities
Time Frame: From start of BEAM through Day 30 post-AHCT
From start of BEAM through Day 30 post-AHCT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VIVUS LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

April 1, 2025

First Submitted That Met QC Criteria

April 1, 2025

First Posted (Actual)

April 8, 2025

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LY-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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