Rituximab, Carmustine; Cytarabine, Etoposide, & Melphalan; Stem Cell Transplantation for Non-Hodgkin's Lymphoma

OBJECTIVES:

• Determine the levels of soluble CD20 antigen (sCD20) in the blood before and after treatment with rituximab and carmustine, cytarabine, etoposide, and melphalan followed by autologous hematopoietic stem cell transplantation in patients with CD20-positive B-cell non-Hodgkin's lymphoma.
• Correlate the effect of changes in levels of sCD20 with clinical outcomes in patients treated with this regimen.
• Determine the response rate in patients treated with this regimen.
• Determine the event-free survival of patients treated with this regimen.
• Determine the toxicity profile of this regimen in these patients.

OUTLINE: Patients receive rituximab IV over approximately 3-4 hours once weekly for 2 weeks followed 1 week later by hematopoietic stem cell or bone marrow harvest.

Patients then receive a third dose of rituximab IV over approximately 3-4 hours on day -7 or -6. Patients also receive high-dose chemotherapy comprising carmustine IV on day -6, cytarabine IV and etoposide IV twice daily on days -5 to -2, and melphalan IV on day -1. Patients undergo autologous hematopoietic stem cell transplantation on day 0.

Patients who have less than a complete remission at day 100 post-transplantation receive 4 additional doses of rituximab IV over approximately 3-4 hours once weekly for 4 weeks.

Patients are followed at day 100, at 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Inclusion criteria

• Diagnosis of non-Hodgkin's lymphoma

o Any B cell

• CD20-positive disease
• Failed prior primary induction therapy
• Meets 1 of the following criteria:

• Chemotherapy-refractory disease
• Received at least 3 prior chemotherapy regimens
• Mantle cell lymphoma
• Eligible for transplantation
• 19 years old and over
• WHO 0-2
• Life expectancy at least 6 months
• Absolute neutrophil count ≥ 1,000/mm^3*
• Platelet count > 50,000/mm^3*
• Hemoglobin > 9.0 g/dL*

o NOTE: *Unless due to lymphomatous involvement of the bone marrow

• Fertile patients must use 2 methods of effective contraception

Exclusion criteria

• No history of T-cell lymphoma
• Not pregnant or nursing
• No other concurrent serious disease or condition that would preclude study participation