A Randomized Phase III Trial of ICE Chemotherapy With or Without Rituximab for the Treatment of Relapsed or Refractory CD20 Expressing Aggressive B-Cell Non-Hodgkin's Lymphomas in Patients Not Suitable for High Dose Therapy and PBSCT

Trial Information

A Randomized Phase III Trial of ICE Chemotherapy With or Without Rituximab for the Treatment of Relapsed or Refractory CD20 Expressing Aggressive B-Cell Non-Hodgkin's Lymphomas in Patients Not Suitable for High Dose Therapy and PBSCT

OBJECTIVES: I. Compare the progression-free and overall survival of patients with relapsed
or refractory, CD20 expressing, aggressive, B-cell non-Hodgkin's lymphoma treated with
ifosfamide, carboplatin, and etoposide with or without rituximab. II. Compare the
unconfirmed response rate of patients treated with these regimens. III. Determine the
toxicity of ifosfamide, carboplatin, and etoposide with rituximab in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to histology (large
B-cell vs other) and risk group (low/low-intermediate vs high-intermediate/high). Patients
are randomized to one of two treatment arms. Arm I: Patients receive etoposide IV over 1
hour on days 1-3, carboplatin IV over 1 hour on day 2, ifosfamide IV continuously for 24
hours on day 2, and filgrastim (G-CSF) subcutaneously (SC) on days 5-12. Treatment continues
every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive rituximab IV on day 1, etoposide IV over 1 hour on days 2-4,
carboplatin IV over 1 hour on day 3, ifosfamide IV continuously for 24 hours on day 3, and
G-CSF SC on days 6-13. Patients also receive rituximab IV on day 8 of course 1. Treatment
continues every 3 weeks for 3 courses in the absence of disease progression or unacceptable
toxicity. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and
then annually for 5 years.

PROJECTED ACCRUAL: A total of 376 patients (188 per arm) will be accrued for this study
within 3 years.