Combination Chemotherapy in Treating Patients With Burkitt's Lymphoma or Burkitt's Leukemia

NCT00040690 | Completed Phase 2

• 3 other identifiers: CDR0000069374MRC-LY10EU-20117
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Leukemia; Lymphoma

Keywords

untreated adult acute lymphoblastic leukemia; L3 adult acute lymphoblastic leukemia; stage I adult Burkitt lymphoma; stage III adult Burkitt lymphoma; stage IV adult Burkitt lymphoma; contiguous stage II adult Burkitt lymphoma; noncontiguous stage II adult Burkitt lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

Secondary Outcomes (1)

• Survival time

Interventions

filgrastim BIOLOGICAL

cyclophosphamide DRUG

cytarabine DRUG

doxorubicin hydrochloride DRUG

etoposide DRUG

ifosfamide DRUG

leucovorin calcium DRUG

methotrexate DRUG

vincristine sulfate DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Medical Research Council: lead

Study Sites (1)

Medical Research Council Clinical Trials Unit

London, England, NW1 2DA, United Kingdom

Location

Related Publications (1)

• Mead GM, Barrans SL, Qian W, Walewski J, Radford JA, Wolf M, Clawson SM, Stenning SP, Yule CL, Jack AS; UK National Cancer Research Institute Lymphoma Clinical Studies Group; Australasian Leukaemia and Lymphoma Group. A prospective clinicopathologic study of dose-modified CODOX-M/IVAC in patients with sporadic Burkitt lymphoma defined using cytogenetic and immunophenotypic criteria (MRC/NCRI LY10 trial). Blood. 2008 Sep 15;112(6):2248-60. doi: 10.1182/blood-2008-03-145128. Epub 2008 Jul 8.

  PMID: 18612102 RESULT

MeSH Terms

Conditions

Leukemia; Lymphoma; Burkitt Lymphoma

Interventions

Filgrastim; Cyclophosphamide; Cytarabine; Doxorubicin; Etoposide; Ifosfamide; Leucovorin; Methotrexate; Vincristine; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Oxazines; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Aminopterin; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Therapeutics

Study Officials

• Simon Clawson

  Medical Research Council

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 8, 2002
• First Posted: January 27, 2003
• Study Start: November 1, 2008
• Study Completion: December 1, 2008
• Last Updated: December 19, 2013

Record last verified: 2007-05

Locations

GB (1)