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

Part of paid clinical trials in Goodyear, Arizona.

Sponsor
VIVUS LLC
Study ID
NCT06915246
Phase
PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VI-0609 — DRUG
    Carmustine with Propylene Glycol
  • BiCNU — DRUG
    Carmustine with Ethanol

Study Details

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

Key Dates

Start date
Mar 12, 2025
Status verified
Mar 2026
Primary completion
Mar 31, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
49 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: VI-0609
    VI-0609 (Carmustine with Propylene Glycol)
  • Active Comparator: BiCNU
    BiCNU (Carmustine with Ethanol)

Primary Outcome Measure

Evaluation of infusion-related toxicities [ Time Frame: Within 24 hours post infusion ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
City of Hope PhoenixGoodyearArizona85338
Anna Keryan
626-218-1124
City of Hope National Medical CenterDuarteCalifornia91010
Anna Keryan
626-218-1124
City of Hope AtlantaNewnanGeorgia30265
Anna Keryan
626-218-1124
City of Hope ChicagoZionIllinois60099
Anna Keryan
626-218-1124

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