Actively Recruiting
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
Eligibility Criteria
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
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
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
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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