VP and G-CSF With or Without Rituximab in Autologous Peripheral Stem Cell Transplant For NHL

OBJECTIVES:

• Determine whether mobilization with etoposide and filgrastim (G-CSF) with or without rituximab influences CD34+ cell yield in patients undergoing autologous peripheral blood stem cell transplantation for B-cell non-Hodgkin's lymphoma.
• Determine the acute toxicity of rituximab in combination with etoposide and G-CSF for peripheral blood stem cell mobilization in these patients.

OUTLINE: This is a randomized study.

• Stem cell mobilization: Patients are randomized to 1 of 2 mobilization arms.

• Arm I: Patients receive rituximab IV over 4 hours on days 1, 8, and 15. Patients also receive etoposide IV over 4 hours on day 15 and filgrastim (G-CSF) subcutaneously (SC) beginning on day 17 and continuing until approximately day 25. Patients then undergo apheresis over 5 days or until an adequate amount of stem cells are collected. After stem cell collection is completed, patients proceed to the preparative regimen.
• Arm II: Patients receive etoposide IV over 4 hours on day 1 and G-CSF SC beginning on day 3 and continuing until approximately day 11. Patients then undergo apheresis over 5 days or until an adequate amount of stem cells are collected. After stem cell collection is completed, patients proceed to the preparative regimen.
• Preparative regimen: Patients receive oral busulfan once daily on days -8 to -4, etoposide IV over 4 hours on day -4, and cyclophosphamide IV over 2 hours on days -3 and -2.
• Autologous peripheral blood stem cell transplantation (PBSCT): Patients undergo autologous PBSCT on day 0. Beginning on day 5, patients receive G-CSF SC or IV once daily until blood counts recover.

After completion study treatment, patients are followed periodically for 10 years.

PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Patients with B-cell malignancies who are appropriate candidates for high-dose chemotherapy and autologous stem cell transplantation and meet 1 of the following criteria:

• Relapsed or refractory B-cell non-Hodgkin's Lymphoma (NHL)
• Patients with B-cell NHL in first remission and who have significant risk for later relapse
• Patients with other B-cell malignancies otherwise eligible for autologous stem cell transplantation

PATIENT CHARACTERISTICS:

• Life expectancy at least 2 months
• Cardiac ejection fraction ≥ 45%
• DLCO ≥ 45%
• Creatinine < 2.0 mg/dL
• Bilirubin < 2.0 mg/dL
• AST < 2 times normal
• Platelet count ≥ 50,000/mm^3
• Absolute neutrophil count ≥ 1,500/mm^3
• Absolute lymphocyte count ≤ 10,000/mm^3
• HIV negative
• No severe medical or psychiatric illnesses
• Not pregnant or nursing
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• More than 8 weeks since prior rituximab