Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06915246

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

Led by VIVUS LLC · Updated on 2026-03-27

49

Participants Needed

4

Research Sites

111 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older with life expectancy of at least 6 months
  • Karnofsky performance status of 70% or higher
  • Histologically confirmed Hodgkin lymphoma or Non-Hodgkin lymphoma
  • Suitable candidate for autologous hematopoietic cell transplantation consolidation therapy
  • Achieved complete or partial response to prior lymphoma treatment
  • Completed collection of at least 2.0 x 10^6 CD34 cells/kg of autologous hematopoietic progenitor cells by apheresis
  • Recovery from non-blood-related toxicities of prior chemotherapy to grade 2 or less
  • Clinical laboratory and organ function within study limits: LVEF 50% or higher, FEV1 greater than 65% predicted, DLCO 50% or higher predicted
  • Negative for HIV antigen/antibody combo, hepatitis C virus, active hepatitis B virus, and syphilis
Not Eligible

You will not qualify if you...

  • Prior high-dose chemotherapy with autologous or allogeneic stem cell transplant
  • Significant prior radiation to critical organs that limits dose
  • Use of other investigational drugs or devices, or concurrent biological, chemotherapy, or radiation therapy
  • Myelodysplasia or any active cancer other than Hodgkin or Non-Hodgkin lymphoma, or less than 5 years remission from other cancers
  • Bone marrow cytogenetic abnormalities linked to myelodysplasia
  • Persistent bone marrow involvement (over 10%) with lymphoma after salvage therapy before stem cell mobilization
  • Insufficient bone marrow harvest for adequate transplant cell dose
  • Active hepatitis B or C infection or positive hepatitis B surface antigen
  • Positive HIV antibody test

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

City of Hope Phoenix

Goodyear, Arizona, United States, 85338

Actively Recruiting

2

City of Hope National Medical Center

Duarte, California, United States, 91010

Actively Recruiting

3

City of Hope Atlanta

Newnan, Georgia, United States, 30265

Actively Recruiting

4

City of Hope Chicago

Zion, Illinois, United States, 60099

Actively Recruiting

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Research Team

V

VIVUS Clinical

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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