Trial Information

High Dose Combined Modality Therapy With Peripheral Blood Progenitor Cell Transplantation as Primary Treatment for Patients With Mantle Cell Lymphoma

OBJECTIVES: I. Evaluate the response to a 8 week induction chemotherapy program consisting
of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in patients with mantle
cell lymphoma. II. Evaluate the efficacy of ifosfamide, carboplatin, and etoposide (ICE)
chemotherapy and filgrastim (G-CSF) for peripheral blood stem cell (PBSC) mobilization in
this patient population. III. Evaluate the safety and efficacy of ICE followed by total body
irradiation and high dose cyclophosphamide and etoposide in this patient population. IV.
Assess the contamination of PBSCs by lymphoma cells following mobilization by chemotherapy
and G-CSF in this patient population.

OUTLINE: Patients receive induction chemotherapy with cyclophosphamide IV, doxorubicin IV,
and vincristine IV on day 1, oral prednisone daily on days 2-6, and filgrastim (G-CSF)
subcutaneously daily on days 6-10. Treatment is repeated every 14 days for up to 4 courses.
Patients receive consolidation chemotherapy with ifosfamide IV over 24 hours and carboplatin
IV on day 2, etoposide IV daily on days 1-3, and G-CSF subcutaneously on days 5-12 for
course 1, and on day 5 for course 2 and continuing through peripheral blood stem cell (PBSC)
collection. Treatment is repeated every 14 days for 2 courses. Following PBSC collection,
patients receive total body irradiation twice a day for 4 days plus etoposide IV over 72
hours on days -6, -5, and -4 and cyclophosphamide IV daily on days -3 and -2. PBSCs are
infused on day 0. Patients receive G-CSF IV or subcutaneously twice a day beginning on day
1. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and
annually thereafter.

PROJECTED ACCRUAL: Approximately 14-24 patients will be accrued for this study within two
years.