Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed Burkitt's Lymphoma or Leukemia

OBJECTIVES:

Primary

- Determine the overall response rate, 1-year event-free survival, and overall survival of
adult patients with newly diagnosed Burkitt or atypical Burkitt lymphoma or leukemia
treated with dose-intensified induction therapy comprising cyclophosphamide,
vincristine, prednisone, and rituximab followed by consolidation therapy comprising
rituximab and high-dose cyclophosphamide.

- Determine the grade 3 or higher non-hematologic toxic effects and overall tolerability
of this regimen in these patients.

Secondary

- Determine the 3-year event-free survival and overall survival of patients treated with
this regimen.

- Determine the general patterns of CNS and systemic relapse in patients treated with this
regimen.

OUTLINE: This is a multicenter study.

- Dose-intensified CVP induction therapy: Patients receive cyclophosphamide IV and
vincristine IV on day 1. Patients also receive oral prednisone on days 1-5 and rituximab
IV on days 1 and 8, and high-dose methotrexate IV with leucovorin calcium IV rescue on
day 8. Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on
day 3 and continuing until blood counts recover. Treatment repeats approximately every
14 days for 2 courses.

- CNS therapy: Patients receive cytarabine intrathecally (IT) with or without
hydrocortisone IT on days 1, 4, and 11 of each induction therapy course. Patients with
evidence of CNS involvement by lymphoma continue to receive cytarabine IT twice weekly
during any induction therapy treatment delay. Patients who demonstrate CSF clearance
receive cytarabine IT once weekly for 4 doses and then once every other week for 4 doses
during consolidation therapy. Patients with disease progression during induction therapy
or persistent CNS involvement by lymphoma are removed from the study. All other patients
proceed to consolidation therapy.

- Consolidation therapy: Patients receive rituximab IV on day -4 and high-dose
cyclophosphamide IV on days -3, -2, -1, and 0. Patients receive G-CSF SC once daily
beginning on day 6 and continuing until blood counts recover OR pegfilgrastim SC once on
day 6. Patients then receive rituximab IV once weekly for 4 weeks in the absence of
disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 3 years.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 3 years.

DISEASE CHARACTERISTICS:

- Histologically confirmed diagnosis of 1 of the following:

- Classic, sporadic Burkitt's lymphoma

- Burkitt's leukemia (FAB L3 acute lymphoblastic leukemia)

- Atypical Burkitt/Burkitt's-like lymphoma or leukemia, defined by the following
criteria:

- Characteristic morphologic features

- High proliferative index AND Ki-67 ≥ 85%

- Any stage allowed

- Newly diagnosed or untreated disease

- Steroids allowed

PATIENT CHARACTERISTICS:

Age

- 30 and over

Performance status

- Not specified

Life expectancy

- Not specified

Renal

- No known irreversible renal dysfunction that would preclude treatment with high-dose
cyclophosphamide

Cardiovascular

- No known significant cardiac dysfunction that would preclude treatment with high-dose
cyclophosphamide

Other

- Not pregnant or nursing

- No known HIV positivity

- No other malignancy within the past 3 years except basal cell or squamous cell skin
cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior chemotherapy for lymphoma

- A maximum of 2 prior doses of intrathecal chemotherapy are allowed

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiation therapy for lymphoma

Surgery

- Prior complete or incomplete surgical resection of lymphoma allowed