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

Phase 2

Recruiting

• Conditions: Lymphoma; Hodgkin Lymphoma; Non-Hodgkin Lymphoma
• Interventions: Drug: VI-0609; Drug: BiCNU

• Registration Number: NCT06915246
• Lead Sponsor: VIVUS LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-12
• Status Verified: 2025-04
• Study First Submitted: 2025-04-01
• Study First Submitted QC: 2025-04-01
• Last Update Submitted: 2025-04-07
• Study First Posted: 2025-04-08
• Last Update Posted: 2025-04-10
• Primary Completion: 2026-03-31
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 49

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VI-0609	VI-0609	VI-0609 (Carmustine with Propylene Glycol)
BiCNU	BiCNU	BiCNU (Carmustine with Ethanol)

Primary Outcome Measures

Name	Time	Method
Evaluation of unacceptable toxicities	From start of BEAM through Day 30 post-AHCT
Evaluation of infusion-related toxicities	Within 24 hours post infusion

Trial Locations

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