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Study of Carmustine Formulations for Lymphoma

This study is testing two different forms of a chemotherapy drug called carmustine for people with lymphoma (a type of cancer that affects immune cells). One form is called VI-0609 (carmustine with propylene glycol) and the other is BiCNU (carmustine with ethanol). Researchers want to see if one form causes fewer infusion-related toxicities (side effects during or shortly after the drug is given) within 24 hours, and fewer unacceptable toxicities up to 30 days after a stem cell transplant. You might be able to join if you are an adult aged 18 or older with Hodgkin or Non-Hodgkin lymphoma, have a good performance status, are a candidate for a stem cell transplant, and have already responded to treatment. The current recruitment status is unclear.

Study design
This is a Phase 2 study comparing two carmustine formulations in people with lymphoma. It plans to enroll 49 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Infusion-related toxicities are evaluated within 24 hours post-infusion, and unacceptable toxicities are evaluated up to 30 days after a stem cell transplant.

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NCT06915246

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
VIVUS LLC
~49 participants
Updated 2026-03-27 on ClinicalTrials.gov
What's tested:VI-0609BiCNU

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluation of infusion-related toxicities
Measured over Within 24 hours post infusion
+1 more outcome measured

Conditions

Lymphoma
Non-Hodgkin Lymphoma
Hodgkin Lymphoma

Explore related trials

Hodgkin's GranulomaNon-Hodgkin Lymphoma

Where it's being run

4 sites across 4 states
Arizona1
California1
Georgia1
Illinois1

Who to contact

VIVUS Clinical
[email protected]
+1-888-998-4887
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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;

What this trial measures

  • Evaluation of infusion-related toxicitiesWithin 24 hours post infusion
  • Evaluation of unacceptable toxicitiesFrom start of BEAM through Day 30 post-AHCT