Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	16 and over	NCI	CALGB-10002 NCT00039130

Objectives

1. 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.
2. Determine the progression-free and overall survival of patients treated with this regimen.
3. Determine the feasibility and toxicity of this regimen in these patients.

Entry Criteria

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

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

Surgery:

• Not specified

Patient Characteristics:

Age:

• 16 and over

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

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

Expected Enrollment

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

Outcomes

Complete response rate
Progression-free and overall survival
Feasability and toxicity

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.
• 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 daily 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.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

John Byrd, MD, Protocol chair		Ph: 614-293-9869 Email: john.byrd@osumc.edu

Related Information

PDQ® clinical trial CALGB-8461

Registry Information
Official Title		Phase II Study Of Rituximab And Short Duration, High Intensity Chemotherapy With G-CSF Support In Previously Untreated Patients With Burkitt Lymphoma/Leukemia
Trial Start Date		2002-05-15
Trial Completion Date		2012-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00039130
Date Submitted to PDQ		2002-03-29
Information Last Verified		2009-10-06
NCI Grant/Contract Number		CA31946

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