A Randomized Phase 2 Study of Carmustine Formulated With and Without Ethanol as Part of BEAM Chemotherapy Conditioning for Subjects With Lymphoma Undergoing Autologous Hematopoietic Cell Transplantation (AHCT)
A phase 2 multicenter study of VI-0609 vs BiCNU in the BEAM high-intensity conditioning regimen for AHCT in subjects with lymphomas.
• 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