AIEOP-BFM ALL 2009 PDF

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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J Clin Oncol Male, Female Trial protocol: Cancer AND drug name.

Support Center Support Center. Children, Adolescents, Under 18 Gender: International, multicenter, randomized clinical trial Phase III. 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.

Pneumonia AND sponsor name. Please review our privacy policy. International collaborative treatment protocol for children and adolescents with acute lymphoblastic leukemia Medical condition: Trials with results Trials without results Clear advanced search filters.

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 xll BFM trials particularly when MRD measurement is not feasible [19].

Parental consent was given for all patients at the hospitals and a copy forwarded to CCIA. Both Female Only Male Only. Information not available in EudraCT.

Clinical trials for AIEOP-BFM ALL 2009

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]. No results available EudraCT Number: This will provide an RSS feed for clinical trials matching your search that have been added or 209 in the last 7 days.

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National Center for Biotechnology InformationU. Displaying page 1 of 1. 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 Zll group.

There are no substantial differences between the patients analysed for MRD at day 15 and the whole group. Receiver operating characteristic ROC analysis was performed using Medcalc to estimate the best discriminatory thresholds for MRD [15]. Patients Patients on this trial were stratified into risk groups using MRD levels at day 33 and day 79 and other risk factors [4].

Obtained funding MN MH. In contrast it was significant for precursor B-ALL patients at both time points. Further study of the value of day 15 MRD is needed to overcome the limitations inherent in doing a retrospective study on an incomplete set of patient samples.

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Query did not match any studies. End of recruitment; From a clinical perspective, ALL patients have been stratified into high, intermediate and standard treatment risk groups.

Giles1 Anita Y. 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.

Clear advanced search filters. Relapse-free survival RFS was defined as time from remission to either relapse or last clinical follow up.

SR patients identified by at least one sensitive marker: The MRD results at day 15 and day 33 were first evaluated by comparing the proportion aifop-bfm patients with low, moderate, high and very high levels of MRD in relapsed and non-relapsed patients Figure 2.

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This a,l was funded by project grants and from the National Health and Medical Research Council www. Date study was submitted in EudraCT. Download Options Subscribe to this Search. International collaborative treatment protocol for children and adolescents with acute lymphoblastic leukaemia.

AIEOP-BFM ALL 2009

IMP with orphan designation in the indication. Published online Oct However, the identification and use of at least two sensitive markers is still to be attempted. Reviewed and contributed to the manuscript and approved final form: Previous studies and the patient characteristics shown in Aieo;-bfm 1suggested that other factors may influence relapse outcomes.

Monitoring Tanja Schindelmeiser Univ. Trial documentation Melanie Gerzmehle Univ. The number of patients and 5 year relapse-free survival percentage are given for each subgroup. These data collectively suggested that the early MRD timepoints can aieop-bffm additional prognostic information useful for stratifying patients with precursor B-ALL.

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.

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]. Table 1 Characteristics of the patient cohort for this study.

Trials with results Trials without results. Received Jun 25; Accepted Aug 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