Trial Information

Phase II Study Of Rituximab And Short Duration, High Intensity Chemotherapy With G-CSF Support In Previously Untreated Patients With Burkitt Lymphoma/Leukemia

OBJECTIVES:

- Determine the complete response rate in patients with previously untreated Burkitt's
lymphoma or Burkitt's leukemia treated with rituximab and high-intensity chemotherapy
with filgrastim (G-CSF) support.

- Determine the progression-free and overall survival of patients treated with this
regimen.

- Determine the feasibility and toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to disease (leukemia
vs lymphoma).

- Course 1: Patients receive cyclophosphamide IV over 5-15 minutes daily on days 1-5 and
oral prednisone on days 1-7. Allopurinol PO will be given on days 1-14.

- Courses 2, 4, and 6: Patients receive ifosfamide IV over 1 hour daily on days 1-5;
vincristine IV over 10 minutes and methotrexate IV over 24 hours on day 1; leucovorin
calcium IV over 15 minutes every 6 hours on day 2; cytarabine IV over 2 hours on days 4
and 5 and etoposide IV over 1 hour daily on days 4 and 5; oral dexamethasone daily on
days 1-5; and methotrexate and cytarabine intrathecally (IT) on day 1. During course 2,
patients receive rituximab IV over 1-4 hours on days 8, 10, and 12. During courses 4
and 6, patients receive rituximab IV over 1 hour on day 8. Patients also receive
filgrastim (G-CSF) subcutaneously (SC) beginning on day 7 and continuing until blood
counts recover.

- Courses 3, 5, and 7: Patients receive cyclophosphamide IV over 5-15 minutes daily on
days 1-5; vincristine IV over 10 minutes and methotrexate IV over 24 hours on day 1;
leucovorin calcium IV every 6 hours on day 2; doxorubicin IV daily on days 4 and 5;
oral dexamethasone daily on days 1-5; methotrexate and cytarabine IT on day 1; and
rituximab IV over 1 hour on day 8. Patients also receive G-CSF as in courses 2, 4, and
6. After course 3, treatment continues in the absence of disease progression or
unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually for 5 years.

PROJECTED ACCRUAL: A total of 100 patients (50 per stratum) will be accrued for this study
within 3 years.