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

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 autologoushematopoietic 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 priorallogeneic transplantation;

• Significant prior external beam dose-limiting radiation to a critical organ based onreview 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 remissionfrom any other prior malignancy;

• Any cytogenetic abnormality in the bone marrow that is known to be associated withor predictive of myelodysplasia;

• Persistent marrow involvement (>10%) with HL or NHL after salvage cytoreductivetherapy and before stem cell mobilization;

• Not having sufficient bone marrow harvest to reach adequate cell dose fortransplant;

• Active hepatitis B or C viral infection or HBsAg positive;

• Positive HIV antibody;