Recruiting
Phase 2

Carmustine & Ethanol

Sponsor:

VIVUS LLC

Code:

NCT06915246

Conditions

Lymphoma

Non-Hodgkin Lymphoma

Hodgkin Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

VI-0609

BiCNU

Study Details

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

Study ID

NCT06915246

Start date

Mar 12, 2025

Status verified date

Mar, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

49 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: VI-0609

VI-0609 (Carmustine with Propylene Glycol)

active comparator: BiCNU

BiCNU (Carmustine with Ethanol)

Interventions

VI-0609

Carmustine with Propylene Glycol

BiCNU

Carmustine with Ethanol

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

VIVUS Clinical

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

Locations

City of Hope Phoenix

Recruiting

Goodyear, Arizona, United States, 85338

Contacts

Anna Keryan

626-218-1124akeryan@coh.org

City of Hope National Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Anna Keryan

626-218-1124akeryan@coh.org

City of Hope Atlanta

Recruiting

Newnan, Georgia, United States, 30265

Contacts

Anna Keryan

626-218-1124akeryan@coh.org

City of Hope Chicago

Recruiting

Zion, Illinois, United States, 60099

Contacts

Anna Keryan

626-218-1124akeryan@coh.org

More Information

Sponsor

VIVUS LLC

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Keywords

  • Lymphoma
  • AHCT
  • BiCNU
  • Carmustine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by VIVUS LLC on 2026-03-27.