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 number of patients and 5 year relapse-free survival percentage are given for each subgroup.

This study has shown in children treated for aieo-bfm 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. Please review our privacy policy.

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

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. Summary Details Full Trial Details.

Clinical Trials Register

Monitoring Tanja Schindelmeiser Univ. No results available EudraCT Number: MRD at day 15 of therapy provided aieop-gfm 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.

This study was funded by project grants and from the National Health and Medical Research Council www. Clear advanced search filters.

Support Center Support Center. 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. Statistics Relapse-free survival RFS was defined as time from remission to either relapse or last clinical follow up. Date study was submitted in EudraCT.


However, the identification and use of at least two sensitive markers is still to be attempted. Relapse-free survival RFS was defined as time from remission to either relapse or last clinical follow up. Previous studies and the patient characteristics shown in Table 1suggested that other factors may influence relapse outcomes.

Marshall13 Murray D. The higher proportion of medium risk patients left out of this study reflects the fact that all 14 patients with no suitable MRD assay and no other high risk features were stratified by definition to the medium risk group.

Displaying page 1 of 1. Clonal rearrangements of immunoglobulin and T-cell receptor genes had previously been identified for each patient by PCR and sequencing.

Clinical trials for AIEOP-BFM ALL 2009

British Journal of Haematology Reviewed and contributed to the manuscript and approved final form: Trials shown on current page Selected Trials only. 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].

The authors have declared that no competing interests exist. Male, Female Trial protocol: EU Clinical Trials Register. Trial documentation Melanie Gerzmehle Univ.

Conceived and designed the experiments: IMP with aieip-bfm designation in the indication.

The day 15 MRD analysis was performed retrospectively using the more sensitive or the first marker used for stratification. Query did not match any studies. English translations are still in development. Parental consent was given for all patients at the hospitals and a copy forwarded to CCIA.


Standard risk and medium risk patients were treated uniformly according to the common control arm in BFM ALL 2009 high risk patients were assigned to treatment with novel high risk chemotherapy blocks [4]. 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 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.

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]. 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].

Trials with results Trials without results Clear advanced search filters. Receiver operating characteristic ROC analysis was performed using Medcalc to estimate the best discriminatory thresholds for MRD [15]. There are no substantial differences between the patients analysed for MRD at day xieop-bfm and the whole group.

The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Giles1 Anita Y. Anna Kinderkrebsforschung Full Title: