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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Assessment of optimal thresholds for MRD prediction of relapse. These data collectively suggested that the early MRD timepoints can provide additional prognostic information useful for stratifying patients with precursor B-ALL.

Parental consent was given for all patients at the hospitals and a copy forwarded to CCIA. EU Clinical Trials Register. Trials shown on current page Selected Trials only.

International, multicenter, randomized clinical trial Phase III. Table 1 Characteristics of the patient cohort for this study.

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 qll the end of induction with reductions in MRD providing a surrogate end-point. These thresholds, rounded to the nearest half log value, were applied in survival analyses. SR patients identified by at least one sensitive marker: This is an open-access akl distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any aioep-bfm, provided the original author and source are properly credited.

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

The authors have declared that no competing interests exist. Our results suggested that use of MRD criteria based on a single timepoint day 15 or day 33 would not aiwop-bfm helpful but that stratification could be improved by using both early timepoints.


The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. These effects were not apparent in the 30 T-ALL patients but were maintained in the whole cohort.

Progress in the treatment of acute lymphoblastic leukaemia in children and adolescents has been made in aiwop-bfm last 10 to15 years mainly through refinement of risk stratification and adaptation of chemotherapy.

For these items you should use the filters and not add them to your search terms in the text field. Obtained funding MN MH. 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]aieop-bmf. Query did not match any studies.


Identification of a new poor early response group within medium risk for MRD risk stratification. This will provide an RSS feed for clinical trials matching your search that have been added or updated in the last 7 days. Pediatr Blood Cancer New agents with proven benefit in the frontline therapy of Alll have not been identified, therefore, wll could only be improved by more effective combination of existing agents.

Trial documentation Melanie Gerzmehle Univ.

Clinical Trials Register

The purpose of this study was to further improve stratification by MRD measurement at an earlier stage. Previous studies and the patient characteristics shown in Table 1suggested that other factors may influence relapse outcomes.

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

Results The MRD results at day 15 and day 33 were first evaluated by comparing the proportion of patients with low, moderate, high aidop-bfm very high levels of MRD in relapsed and non-relapsed patients Figure 2.


National Center for Biotechnology InformationU.

Clinical trials for AIEOP-BFM ALL 2009

Clear advanced search filters. 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. 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.

Receiver operating characteristic ROC analysis was performed using Medcalc to estimate the best discriminatory thresholds for MRD [15].

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. Children, Adolescents, Under 18 Gender: Giles1 Anita Y. While there is good reason to xll 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 Medical condition: Statistics Relapse-free survival RFS was defined as time from remission to either relapse or last clinical follow up.