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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Clinical trials for AIEOP-BFM ALL 2009

Conceived and designed the experiments: The morphological examination of bone marrow aspirates at day 15 was established airop-bfm as a prognostic indicator of poor outcome [18] and this remains relevant in BFM trials particularly when MRD measurement is not feasible [19]. 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.

International collaborative treatment protocol for children and adolescents with acute lymphoblastic leukemia. Open in a separate window.

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Previous studies and the patient characteristics shown in Table 1suggested that other factors may influence relapse outcomes. Pediatr Blood Cancer IMP with orphan designation in the indication.

Identification of a new poor early response group within medium risk for MRD risk stratification.

The separate analysis of precursor B and T-ALL patients in BFM protocols has improved our understanding aiepp-bfm response to therapy and risk [5][12][15][19]. Patients on this trial were stratified into risk groups using MRD levels at day 33 and day 79 and other risk factors [4].


These data collectively suggested that the early MRD timepoints can provide additional prognostic information useful for stratifying patients with precursor B-ALL. This article has been cited by other articles in PMC.

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 positive rate and specificity true negative rate [15][16]. Giles1 Anita Y. Progress in the treatment of aieop-bfmm lymphoblastic leukaemia in children and adolescents has been made in the alll 10 to15 years mainly through refinement of risk stratification and adaptation of chemotherapy.

Trials shown on current page Selected Trials only. Infants and toddlers, Children, Adolescents, Under 18, Adults. Author information Sll notes Copyright and License information Disclaimer. The potential benefit of this alternative patient stratification is clear from a comparison of the original stratification Figure 5B and the new alternative Figure 5C.

No results available EudraCT Number: How to search [pdf].


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. Anna Kinderkrebsforschung Full Title: High Risk patients as identified by day 33 – randomized study question: Assessment of optimal thresholds for MRD prediction of relapse.

Trials with results Trials without results. English translations are still in development. Receiver operating characteristic ROC analysis was performed using Medcalc to estimate the best discriminatory thresholds for MRD [15].

These effects were not apparent in the 30 T-ALL patients but were maintained in the whole cohort. Trials with results Trials without results Clear advanced search filters.


The number of patients and 5 year relapse-free survival percentage are given for each subgroup. Discussion This study has shown in children treated for acute lymphoblastic leukaemia that the rapid clearance of bone marrow disease is associated with a low relapse rate and conversely that patients with high levels of disease have higher rates of relapse. The medium risk group were patients not qualifying for either standard or high risk.

MRD at day 15 of therapy provided additional predictive value in precursor B-ALL patients treated on this MRD intervention protocol and could be used in future to identify additional patients at high risk of relapse.

In contrast it was significant for precursor B-ALL patients at both time points. These thresholds, rounded to the nearest half log value, were applied in survival analyses. We therefore arbitrarily defined an extra MRD threshold for precursor B-ALL patients at both day 15 and day 33 in order to distinguish 3 risk groups with a reasonable number of patients Figure 4C, 4D. 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.

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Query did not match any studies. International collaborative treatment protocol for children and adolescents with acute lymphoblastic leukaemia. Marshall13 Murray D.