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

NCT06915246 | Recruiting Phase 2 FDA Drug

• 1 other identifier: LY-201
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Lymphoma; Non-Hodgkin Lymphoma; Hodgkin Lymphoma

Keywords

Lymphoma; AHCT; BiCNU; Carmustine

Outcome Measures

Primary Outcomes (2)

• Evaluation of infusion-related toxicities

  Within 24 hours post infusion

• Evaluation of unacceptable toxicities

  From start of BEAM through Day 30 post-AHCT

Study Arms (2)

VI-0609

EXPERIMENTAL

VI-0609 (Carmustine with Propylene Glycol)

Drug: VI-0609

BiCNU

ACTIVE COMPARATOR

BiCNU (Carmustine with Ethanol)

Drug: BiCNU

Interventions

BiCNU DRUG

Carmustine with Ethanol

BiCNU

VI-0609 DRUG

Carmustine with Propylene Glycol

VI-0609

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• VIVUS LLC: lead

Study Sites (4)

City of Hope Phoenix

Goodyear, Arizona, 85338, United States

RECRUITING

City of Hope National Medical Center

Duarte, California, 91010, United States

RECRUITING

City of Hope Atlanta

Newnan, Georgia, 30265, United States

RECRUITING

City of Hope Chicago

Zion, Illinois, 60099, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma; Lymphoma, Non-Hodgkin; Hodgkin Disease

Interventions

Carmustine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds

Central Study Contacts

VIVUS Clinical

CONTACT

+1-888-998-4887; clinical@vivus.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 8, 2025
• Study Start: March 12, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)