Treatment and endpoints. – AIEOP-BFM ALL – AIEOP-BFM ALL • Perspectives. ALL, acute lymphoblastic leukemia; MRD, minimal residual disease. Principal investigator of clinical trial. Pr Martin SCHRAPPE; Klinik für Kinder- und Jugendmedizin I; Universitätsklinikum Schleswig-Holstein – Campus Kiel. Blood ; doi: .. Accordingly, in the AIEOP-BFM ALL study, these 2 groups of patients.

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The authors have declared that no competing interests exist. Reviewed and contributed to the manuscript and approved final form: While there is good reason to delay stratification for T-ALL patients in whom the day 79 MRD results provide better prognostic discrimination [12] our analyses suggest that risk assessment of precursor B-ALL can be improved by the combined use of day 15 and day 33 MRD results to identify the PER group.

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Results The MRD results at day 15 and day 33 were first evaluated by comparing the proportion of patients with low, moderate, high and very high levels of MRD in relapsed and non-relapsed patients Figure 2. Trials with results Trials without aioep-bfm Clear advanced search filters. This will provide an RSS feed for clinical trials matching your search that have been added or updated in the last 7 days. Published online Oct SR patients identified by at least one sensitive marker: Patients on this trial were stratified into risk groups using MRD levels at day 33 and day 79 and other 22009 factors [4].

Giles1 Anita Y. In Table 1the characteristics of the whole group of patients are compared with the 89 patients excluded due to lack of day 15 sample or suitable assay; with the patients included and the 53 included patients who relapsed.

Receiver operating characteristic ROC analysis was aieop-bfk using Medcalc to estimate the best discriminatory thresholds for MRD [15].



Information not available in EudraCT. These effects were not apparent in the 30 T-ALL patients but were maintained in the whole cohort. Author information Article notes Copyright and License information Disclaimer.

The exception was a patient with very unusual MRD kinetics with MRD increasing by more than one log level at both day 33 and day Is it possible to improve the outcome and to achieve a further reduction of leukemic cell burden by administration of an innovative treatment schedule DNX-FLA?

English translations are still in development. These thresholds, rounded to the nearest half log value, were applied in survival analyses. Support Center Support Center. International collaborative treatment protocol for children and adolescents with acute lymphoblastic leukemia.

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Better tailoring of treatments to suit different subsets of ALL patients could lead to further improvements in morbidity and mortality for ALL patients. The value of MRD at even earlier timepoints in induction day 15 or day 19 in the identification of patients with particularly favourable outcomes has already been established for MRD measured by quantitative flow cytometry [6][7] and in small PCR-MRD studies [8] — [10].

Identification of a new poor early response group within medium risk for MRD risk stratification. IMP with orphan designation in the indication. Both Female Only Male Only. Clear advanced search filters.

Summary Details Full Trial Details. Our results suggested that use of MRD criteria based on a single timepoint day 15 or day 33 would not be helpful but that stratification could be improved by using both early timepoints. Clonal rearrangements of immunoglobulin and T-cell receptor genes had previously aall identified for each patient by PCR and sequencing. The morphological examination of bone marrow aspirates at day 15 was established early as a prognostic indicator of poor outcome [18] and this remains relevant in BFM trials particularly when MRD measurement is not feasible [19].

Monitoring Tanja Schindelmeiser Univ. International, multicenter, randomized clinical trial Phase III. Progress in the treatment of acute lymphoblastic leukaemia in children and adolescents has been made aieop-bgm the last 10 to15 years mainly through al of risk stratification and adaptation of chemotherapy.


This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited. There are no substantial differences between the patients analysed for MRD at day 15 and the whole group. PCR-MRD methodologies are now well established and the development of PCR-MRD assays for each patient by day 33, involving target detection, sequencing aoeop-bfm primer design, is no longer a difficult challenge.

Male, Female Trial protocol: ROC analysis is used to assess the diagnostic accuracy of a continuous variable and to estimate the threshold which optimizes the balance between sensitivity true aieop-bvm rate and specificity true negative rate [15][16].

Patients Patients on this trial were stratified into risk aieoo-bfm using MRD levels at day 33 and day 79 and other risk factors [4].

Previous studies and the patient characteristics shown in Table 1akl that other factors may influence relapse outcomes. The separate analysis of precursor B and T-ALL patients in BFM protocols has improved our understanding of response to therapy and risk [5][12][15][19]. Earlier stratification of high risk patients in clinical trials may be beneficial in enabling novel treatments to be trialled on patients who achieve only a shallow remission at the end of induction with reductions in MRD providing a surrogate end-point.

The advanced knowledge about 209 of ALL and molecular regulation of treatment response and resistance represents the basis for the design of contemporary treatment protocols. J Clin Oncol