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

NCT06915246 · VIVUS LLC
In plain English

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Official title
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)
About this study
A phase 2 multicenter study of VI-0609 vs BiCNU in the BEAM high-intensity conditioning regimen for AHCT in subjects with lymphomas.
Eligibility criteria
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
Enrollment target: 49 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-03-12
Estimated completion: 2027-04-30
Last updated: 2026-03-27
Interventions
Drug: VI-0609Drug: BiCNU
Primary outcomes
  • Evaluation of infusion-related toxicities (Within 24 hours post infusion)
  • Evaluation of unacceptable toxicities (From start of BEAM through Day 30 post-AHCT)
Sponsor
VIVUS LLC · industry
Contacts & investigators
ContactVIVUS Clinical · contact · clinical@vivus.com · +1-888-998-4887
All locations (4)
City of Hope PhoenixRecruiting
Goodyear, Arizona, United States
City of Hope National Medical CenterRecruiting
Duarte, California, United States
City of Hope AtlantaRecruiting
Newnan, Georgia, United States
City of Hope ChicagoRecruiting
Zion, Illinois, United States
A Study of Carmustine With and Without Ethanol in Subjects With Lymphoma · TrialPath