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RecruitingInterventionalPhase 2

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)

NCT ID: NCT06915246Sponsor: VIVUS LLCLast updated: 2026-03-27

Summary

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

Arms & interventions

  • DrugVI-0609

    Carmustine with Propylene Glycol

  • DrugBiCNU

    Carmustine with Ethanol

Outcome measures

Primary

  • Evaluation of infusion-related toxicities

    Time frame: Within 24 hours post infusion

  • Evaluation of unacceptable toxicities

    Time frame: From start of BEAM through Day 30 post-AHCT

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (4)

City of Hope Phoenix

Goodyear, Arizona, 85338

Recruiting
Anna Keryan · Contact

City of Hope National Medical Center

Duarte, California, 91010

Recruiting
Anna Keryan · Contact

City of Hope Atlanta

Newnan, Georgia, 30265

Recruiting
Anna Keryan · Contact

City of Hope Chicago

Zion, Illinois, 60099

Recruiting
Anna Keryan · Contact