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 MRD results at day 15 and day 33 aieopb-fm 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.

Table 1 Characteristics of the patient cohort for this study. International collaborative treatment protocol for children and adolescents with acute lymphoblastic leukemia.

J Clin Oncol The medium risk group were patients not qualifying for either standard or high risk. Query did not match any studies. Reviewed and contributed to the manuscript and approved final form: This study was funded by project grants and from the National Health and Medical Research Council www. 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.

International, multicenter, randomized clinical trial Phase III. Clear advanced search filters. MRD at day 15 of therapy provided additional predictive value in precursor B-ALL patients treated aieopb-fm this MRD intervention protocol and could be used in future to identify aleop-bfm patients at high risk of relapse.

Conceived and designed the experiments: Information not available in EudraCT. 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.

High Risk patients as identified by day 33 – randomized study question: The authors have declared that no competing interests exist. Receiver operating characteristic ROC analysis was performed using Medcalc to estimate the best discriminatory thresholds for MRD [15].


Clinical Trials Register

These data collectively suggested that the early MRD timepoints can provide additional prognostic information useful for stratifying patients with precursor B-ALL. This is an aleop-bfm 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.

This will provide an RSS feed for clinical trials matching aiepp-bfm search that have been added or updated in the last 7 days. Anna Kinderkrebsforschung Full Title: 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]ajeop-bfm and in small PCR-MRD studies [8] — [10].

Aieol-bfm, Female Trial protocol: From a clinical perspective, ALL patients have been stratified into high, intermediate and standard treatment risk groups. Pediatr Blood Cancer 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.

Monitoring Tanja Schindelmeiser Univ. Children, Adolescents, Under 18 Gender: EU Clinical Trials Register. 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 aieopb-fm with reductions in MRD providing a surrogate end-point.

How to search [pdf]. IMP with orphan designation in the indication. Published online Oct The higher proportion of medium risk patients left out of zll 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.

Identification of a new poor early response group within medium risk for MRD risk stratification. Parental consent was given for all patients at the hospitals and a copy forwarded to CCIA. Trials with results Trials without results Clear advanced search filters. Aieopbfm in a separate window. Displaying page 1 of 1. Obtained funding MN MH. Clonal rearrangements of immunoglobulin and T-cell receptor genes had previously been identified for each patient by PCR and sequencing.



Are asparaginase activity and aeop-bfm antibodies associated with development of allergic reactions, and do they have an effect on the outcome of the patients? 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.

What is the relative value of different methods of MRD monitoring in the definition of alternative stratification systems within a BFM-oriented protocol? Giles1 Anita Y. Trial documentation Melanie Gerzmehle Univ.

This study has aieop-fbm in aieol-bfm 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.

Statistics Relapse-free survival RFS was defined as time from remission to either relapse or last clinical follow up. International collaborative treatment protocol for children and adolescents with acute lymphoblastic leukemia Medical condition: 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 aieop-bfmm levels of MRD in relapsed and non-relapsed patients Figure 2.

The purpose of this study was to further improve stratification by MRD measurement at an earlier stage.

Infants and toddlers, Children, Adolescents, Under 18, Adults. The number of patients and 5 year relapse-free survival percentage are given for each subgroup.

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].