Rituximab, Chemotherapy, and Filgrastim in Treating Patients With Burkitt's Lymphoma or Burkitt's Leukemia



Status:Completed
Conditions:Blood Cancer, Lymphoma, Leukemia
Therapuetic Areas:Oncology
Healthy:No
Age Range:16 - Any
Updated:4/21/2016
Start Date:May 2002
End Date:October 2014

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

RATIONALE: Monoclonal antibodies such as rituximab can locate tumor cells and either kill
them or deliver tumor-killing substances to them without harming normal cells. Drugs used in
chemotherapy use different ways to stop cancer cells from dividing so they stop growing or
die. Colony-stimulating factors such as filgrastim may increase the numbers of immune cells
found in bone marrow or peripheral blood and may help a person's immune system recover from
the side effects of chemotherapy. Combining chemotherapy with rituximab and filgrastim may
kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining rituximab with chemotherapy
and filgrastim in treating patients who have Burkitt's lymphoma or Burkitt's 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.

DISEASE CHARACTERISTICS:

- Histologically, cytogenetically, or immunophenotypically confirmed Burkitt's leukemia
or Burkitt's or Burkitt-like lymphoma

- L3 morphology surface IgG expression

- Cytogenetic evidence for t(8;14), t(8;22), or t(2;8)

- Previously untreated disease except hydroxyurea for leukocytosis

- CNS involvement allowed

- Patients with Burkitt's leukemia or Burkitt's lymphoma with bone marrow involvement
must also be enrolled on CALGB-8461

- Patients with Burkitt's leukemia must also be enrolled on CALGB-9665

PATIENT CHARACTERISTICS:

Age:

- 16 and over

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

Renal:

- Creatinine no greater than 1.5 times ULN

Other:

- HIV negative

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No concurrent interleukin-11

Chemotherapy:

- See Disease Characteristics

- No other concurrent chemotherapy

Endocrine therapy:

- No concurrent hormonal therapy except for non-disease-related conditions (e.g.,
insulin for diabetes)

- No concurrent steroids except for adrenal failure

Radiotherapy:

- No concurrent palliative radiotherapy except whole-brain irradiation for documented
CNS disease
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