- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00040690
Combination Chemotherapy in Treating Patients With Burkitt's Lymphoma or Burkitt's Leukemia
A Clinicopathological Study In Burkitts's And Burkitt-Like Non-Hodgkin's Lymphoma
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have Burkitt's lymphoma or Burkitt's leukemia.
Study Overview
Status
Detailed Description
OBJECTIVES:
- Describe the morphology, phenotype, and cytogenetics, using fresh tumor tissue (when possible), in patients with Burkitt's or Burkitt-like lymphoma/leukemia treated with the CODOX-M chemotherapy regimen (cyclophosphamide, vincristine, doxorubicin, and methotrexate) alone or alternating with the IVAC chemotherapy regimen (ifosfamide, etoposide, and cytarabine).
- Determine whether cytogenetic and molecular changes are associated with or predictable from the immunophenotype of the tumor cells or patient characteristics (e.g., age).
- Examine the relationship between t(14;18) and bcl-2 expression in patients treated with this regimen.
- Determine whether the presence of specific cytogenetic and molecular changes, in particular the presence of t(14;18) and t(8;14), is associated with an adverse outcome (progression-free and overall survival) in patients treated with this regimen.
- Assess the activity of the alternating CODOX-M/IVAC chemotherapy regimens using a lower dose of methotrexate (compared to the UKLG LY06 trial) in these patients.
- Assess further the activity of these regimens in patients with leukemic Burkitt's lymphoma.
- Modify the chemotherapy doses in these regimens to include older patients who are often excluded from clinical trials.
OUTLINE: This is a multicenter study. Patients with low-risk disease are assigned to group A, while patients with high-risk disease are assigned to group B.
Group A (low-risk group):
- Patients receive 3 courses of the CODOX-M chemotherapy regimen comprising cyclophosphamide IV on days 1-5, vincristine IV on days 1 and 8, doxorubicin IV on day 1, and methotrexate (MTX) IV over 24 hours on day 10. Patients over age 65 receive reduced-dose MTX on day 10. All patients receive leucovorin calcium (CF) IV once at hour 36 after initiation of MTX infusion, once every 3 hours between hours 36-48, and continuing once every 6 hours until blood levels of MTX are safe. Patients also receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 13 and continuing until blood counts recover.
- During all 3 courses of the CODOX-M regimen, patients receive CNS prophylaxis comprising cytarabine (ARA-C) intrathecally (IT) on days 1 and 3, MTX IT on day 15, and oral CF (24 hours after IT MTX) on day 16.
Group B (high-risk group):
- Patients receive the CODOX-M chemotherapy regimen (as above) alternating with the IVAC chemotherapy regimen (as defined below) for a total of 4 courses given in the following sequence: CODOX-M, IVAC, CODOX-M, and IVAC. The IVAC chemotherapy regimen comprises ifosfamide (IFF) IV over 1 hour and etoposide IV over 1 hour on days 1-5 and ARA-C IV over 3 hours on days 1 and 2. Patients over age 65 receive reduced-dose IFF and ARA-C. Patients also receive G-CSF SC once daily beginning on day 7 and continuing until blood counts recover.
- During IVAC, patients without CNS disease receive MTX IT on day 5 and oral CF (24 hours after MTX). Patients with proven CNS disease receive intensified IT therapy throughout the first two courses of CODOX-M/IVAC chemotherapy.
For patients in group B with CNS disease at diagnosis, radiotherapy is only considered in the presence of a cerebral mass documented by CT scan or MRI. Patients in group A or B who develop isolated CNS recurrence (documented by malignant CSF pleocytosis, cranial nerve palsies, or both) at any time after the first course of study therapy receive the same CNS treatment (as above) as patients with proven CNS disease in addition to whole brain irradiation for 3 weeks.
Patients are followed monthly for 4 months, every 2 months for 8 months, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A minimum of 120 patients (30 with low-risk disease and 90 with high-risk disease) will be accrued for this study within approximately 3-4 years.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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England
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London, England, United Kingdom, NW1 2DA
- Medical Research Council Clinical Trials Unit
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Diagnosis of diffuse B-cell lymphoma in a nodal or an extranodal site
- CD20 and CD79 positive
- 100% expression of Ki67 (MIB1) in all of the tumor cells OR
Diagnosis of bone marrow replacement/leukemia comprising mature B-cell lymphoma
- sIg and CD19 positive
- CD34 and Tdt negative
Patients in the low-risk group must meet at least 3 of the following criteria:
- Normal lactate dehydrogenase (LDH) level
- WHO performance status 0-1
- Ann Arbor stage I or II
- No more than 1 extranodal site (e.g., bone marrow, gastrointestinal tract, or CNS)
Patients in the high-risk group must meet at least 2 of the following criteria:
- Raised LDH level
- WHO performance status 2-4
- Ann Arbor stage III or IV
- More than 1 extranodal site
PATIENT CHARACTERISTICS:
Age:
- 16 and over
Performance status:
- See Disease Characteristics
Life expectancy:
- Not specified
Hematopoietic:
- See Disease Characteristics
Hepatic:
- See Disease Characteristics
Renal:
- Not specified
Other:
- No mental or physical status that would preclude study
- No other disease or prior malignancy that would preclude study
- HIV negative
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy except 1 course of preinduction chemotherapy (e.g., CHOP [cyclophosphamide, doxorubicin, vincristine, and prednisone] or a related regimen)
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy
Surgery:
- Not specified
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Progression-free survival
|
Secondary Outcome Measures
Outcome Measure |
---|
Survival time
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Virus Diseases
- Infections
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- DNA Virus Infections
- Tumor Virus Infections
- Epstein-Barr Virus Infections
- Herpesviridae Infections
- Lymphoma, B-Cell
- Lymphoma
- Leukemia
- Burkitt Lymphoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Protective Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Dermatologic Agents
- Micronutrients
- Antibiotics, Antineoplastic
- Vitamins
- Reproductive Control Agents
- Antidotes
- Vitamin B Complex
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Cyclophosphamide
- Etoposide
- Ifosfamide
- Leucovorin
- Levoleucovorin
- Doxorubicin
- Liposomal doxorubicin
- Cytarabine
- Methotrexate
- Vincristine
Other Study ID Numbers
- CDR0000069374
- MRC-LY10
- EU-20117
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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