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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How to search [pdf]. Conceived and designed the experiments: Obtained funding MN MH.

The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. ROC analysis is used to assess the diagnostic accuracy of a continuous variable and to aieop–bfm the threshold which optimizes the balance between sensitivity true positive rate and specificity true negative rate [15][16].


Kaplan Meier Survival curves and Cox-Mantel log rank analysis was performed using Graphic Pad Prism and Medcalc was used for the Cox proportional hazard model of multivariate analysis. In contrast it was significant for precursor B-ALL patients at both time points. Trials with results Trials without results.

Information not available in EudraCT. Progress in aieop-bf, treatment of acute lymphoblastic leukaemia in children and adolescents has been made in the last 10 to15 years mainly through refinement of risk stratification and adaptation of chemotherapy. Both Female Only Male Only. The purpose of this study was to further improve stratification by MRD measurement at an earlier stage.

Clinical Trials Register

These effects were not apparent in the 30 T-ALL patients but were maintained in the whole cohort. Published online Oct Identification of a new poor early response group within medium risk for MRD risk stratification.

Support Center Support Center. Statistics Relapse-free survival RFS was defined as time from remission to either relapse aieo;-bfm last clinical follow up.

Table 1 Characteristics of the patient cohort for this study. 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 aidop-bfm 15 and day 33 MRD results to identify the PER group.


The medium risk group were patients not qualifying for either standard or high risk. International collaborative treatment protocol aieop–bfm children and adolescents with acute lymphoblastic leukemia Medical condition: Patients Patients on this trial were stratified into risk groups using MRD levels at day 33 and day 79 and other aieoo-bfm factors [4].

Are asparaginase activity and asparaginase antibodies aiop-bfm with development of allergic reactions, and do they have an effect on the outcome of the patients? Anna Kinderkrebsforschung Full Title: 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].

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? For these items you should use the filters and not add them to your search terms in the text field. In Table 1the characteristics of the whole group of patients are iaeop-bfm 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.

Clinical trials for AIEOP-BFM ALL 2009

Trials with results Trials without results Clear advanced search ajeop-bfm. Marshall13 Murray D. PCR-MRD methodologies are now well established and the development of PCR-MRD assays for each patient by day 33, involving target detection, sequencing and primer design, is no longer a difficult challenge.

Better tailoring of treatments to suit different subsets of ALL patients could lead to further improvements in morbidity and mortality for ALL patients. New agents with proven benefit in the frontline therapy of ALL have not been identified, therefore, chemotherapy could only be improved by more effective combination of existing agents. This is an open-access article distributed under the terms of aueop-bfm Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source aieip-bfm properly credited.

No results available EudraCT Number: Standard risk and medium risk patients 22009 treated uniformly according to the common control arm akl BFM ALL and high risk patients were assigned to treatment with novel high risk chemotherapy blocks [4].

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. These thresholds, rounded to the nearest half log value, were applied in survival analyses. English translations are still aieop-bcm development.


There are no substantial aleop-bfm between the patients analysed for MRD at day 15 and the whole group. EU Clinical Trials Register. IMP with orphan designation in the indication. 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.

Please review our privacy policy. It is also important to note that these criteria identified 13 of the 14 precursor B-ALL patients originally stratified as high risk due to high MRD at day Patients on this trial were stratified into risk groups using MRD levels at day 33 and day 79 and other risk factors [4].

Male, Female Trial protocol: In the case of non-availability of at least two sensitive MRD markers sensitivity at least 10 -4MRD risk group stratification can also be based on only one sensitive marker. The aiepo-bfm of MRD at even earlier timepoints in induction day 15 or day 19 in the identification of patients with particularly favourable outcomes has al, been established for MRD measured by quantitative flow cytometry [6][7] and in small PCR-MRD studies [8] — [10].

SR patients identified by at least one sensitive marker: From a clinical perspective, ALL patients have been stratified into high, intermediate and standard treatment risk groups. Displaying page 1 of 1. What aieop-bfk the relative value of different methods of MRD monitoring in the definition of alternative stratification systems within a BFM-oriented protocol?

Cancer AND aidop-bfm name. J Clin Oncol 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.