A Study of Carmustine With and Without Ethanol in Subjects With Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVIVUS LLC
About this trial
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
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
VI-0609
DrugCarmustine with Propylene Glycol
BiCNU
DrugCarmustine with Ethanol
Treatment groups
49 Participants
are divided into 2 treatment groupsGroup A: VI-0609Experimental treatment 1 intervention
Group B: BiCNUActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Evaluation of infusion-related toxicities
Time frame
Within 24 hours post infusion2
Evaluation of unacceptable toxicities
Time frame
From start of BEAM through Day 30 post-AHCT Source ClinicalTrials.gov