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

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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;
• Any cytogenetic abnormality in the bone marrow that is known to be associated with or predictive of myelodysplasia;
• Persistent marrow involvement (>10%) with HL or NHL after salvage cytoreductive therapy and before stem cell mobilization;
• Not having sufficient bone marrow harvest to reach adequate cell dose for transplant;
• Active hepatitis B or C viral infection or HBsAg positive;
• Positive HIV antibody;