Overview

This trial is active, not recruiting.

Conditions leukemia, lymphoma
Treatments filgrastim, rituximab, cyclophosphamide, cytarabine, dexamethasone, doxorubicin hydrochloride, etoposide, ifosfamide, leucovorin calcium, methotrexate, prednisone, vincristine sulfate, allopurinol
Phase phase 2
Target CD20
Sponsor Cancer and Leukemia Group B
Collaborator National Cancer Institute (NCI)
Start date May 2002
End date September 2010
Trial size 105 participants
Trial identifier NCT00039130, CALGB-10002, CDR0000069354, U10CA031946

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Complete response rate
time frame: 6 months post tx

Secondary Outcomes

Measure
Progression free survival
time frame: 3 years
Toxicity
time frame: Ea tx course; q 3 mon for 2 yrs, q6 mon for 3 yrs, q yr for 5 yrs

Eligibility Criteria

Male or female participants at least 16 years old.

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 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 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

Additional 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
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2011.
Information provided to ClinicalTrials.gov by Cancer and Leukemia Group B.