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Clinical Trial
. 2008 Sep 15;112(6):2248-60.
doi: 10.1182/blood-2008-03-145128. Epub 2008 Jul 8.

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)

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Free PMC article
Clinical Trial

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)

Graham M Mead et al. Blood. .
Free PMC article

Abstract

This prospective study aimed to develop reproducible diagnostic criteria for sporadic Burkitt lymphoma (BL), applicable to routine practice, and to evaluate the efficacy of dose-modified (dm) CODOX-M/IVAC in patients diagnosed using these criteria. The study was open to patients with an aggressive B-cell lymphoma with an MKI67 fraction approaching 100%. Immunophenotype and fluorescent in situ hybridization (FISH) were used to separate BL from other aggressive B-cell lymphomas. BL was characterized by the presence of a cMYC rearrangement as a sole cytogenetic abnormality occurring in patients with a germinal center phenotype with absence of BCL-2 expression and abnormal TP53 expression. A total of 128 patients were eligible for the study, of whom 58 were considered to have BL and 70 to have diffuse large B-cell lymphoma (DLBCL). There were 110 clinically fit patients who received dmCODOX-M (methotrexate, dose 3 g/m(2)) with or without IVAC according to risk group. The 2-year progression-free survival was 64% (95% confidence interval [CI] 51%-77%) for BL, 55% (95% CI 42%-66%) for DLBCL, 85% (95% CI 73%-97%) for low risk, and 49% (95% CI 38%-60%) for high-risk patients. The observed differences in outcome and other clinical features validate the proposed diagnostic criteria. Compared with the previous trial LY06 with full-dose methotrexate (6.7 g/m(2)), there was a reduction in toxicity with comparable outcomes. This study was registered at www.clinicaltrials.gov as NCT00040690.

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Figure 1
Figure 1
Study profile. Study scheme, patient accrual, risk group, and reference diagnosis.
Figure 2
Figure 2
Kaplan-Meier plots of progression-free survival and overall survival. By reference diagnosis (A), risk group and reference diagnosis (B), age group (C), and t(14;18) presence (D).
Figure 3
Figure 3
Kaplan-Meier plots of progression-free survival and overall survival in LY10 and LY06 patients with risk group defined as in LY10.

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