NCT03643276Recrutement en cours
Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017
Résumé
The understanding of acute lymphoblastic leukemia (ALL) in childhood and adolescence has largely changed due to extensive genetic research in recent years: ALL is now considered to be a very heterogeneous disease group. The leukemia cells present themselves with quite differently activated regulatory mechanisms of the malignant phenotype. The introduction of more accurate methods of assessing therapy response ("minimal residual disease \[MRD\] tests") has provided new insights into very different mechanisms of action, including factors influenced by host factors; this has had practical clinical consequences for the use of more individualized therapy. Multimodal therapies have enabled a cure level of over 80% for ALL in this age group. However, the own and international study data show that the therapy toxicity of the contemporary chemotherapy concepts has become unacceptably high, in particular with respect to those intensified therapies used for the treatment of patients at high risk of ALL relapse. The AIEOP-BFM ALL 2017 study therefore aims for an innovative integrated approach that will not only adapt the risk stratification to new prognostic markers using more comprehensive diagnostics, but above all, qualitatively reorient the therapy. The most important consequence will be that this study is testing immunotherapy with the bispecific antibody blinatumomab as an alternative to particularly intensive and toxic chemotherapy elements in precursor B-cell ALL (pB-ALL) patients with detectable chemotherapy resistance and at high risk of relapse. With the aim to complement the effects of the conventional chemotherapy, Blinatumomab is in addition tested in the large group of pB-ALL patients at intermediate relapse risk with seemingly unremarkable leukemia, but who account for a large proportion of all relapses. Targeted therapy is also used in the form of the proteasome inhibitor bortezomib for patients with pB-ALL and slow response to the drugs of the induction chemotherapy with the aim to overcome intrinsic chemotherapy resistance of the ALL cells. In patients with T-lineage ALL, who have particularly poor chances for cure after relapse, the established consolidation chemotherapy has proved to be particularly effective. This chemotherapy phase is therefore tested in a longer and more intensive form in such T-ALL patients with intermediate or slow early treatment response with the aim to reduce the relapses rate in this subgroup.
Critères d'inclusion
• newly diagnosed acute lymphoblastic leukemia or • newly diagnosed mixed phenotype acute leukemia (MPAL) meeting one of the following criteria: • biphenotypic with a dominant T or B lineage assignment • bilineal either with a dominant lymphoblastic population or if another reasonable rationale exists to treat the patient with an ALL-based therapy regimen • newly diagnosed acute undifferentiated leukemia • age \< 18 years (up to 17 years and 365 days) at the day of diagnosis • patient enrolled in a participating center • written informed consent to trial participation and transfer and processing of data A subsequent removal from the study is only allowed if the inclusion criteria turn out not to be fulfilled or in the case of pregnancy of the patient.
Critères d'exclusion
• Ph+ (BCR-ABL1 or t(9;22)-positive) ALL • bilineal leukemia with a lymphoblastic and a separate non-lymphoblastic (≥ 10% of total cells) blast subset • pre-treatment with cytostatic drugs • glucocorticoid pre-treatment with ≥ 1 mg/kg/d for more than two weeks during the last month before diagnosis • treatment started according to another protocol • underlying disease that does not allow treatment according to the protocol (e.g. severe congenital heart disease, Charcot-Marie Syndrome, Ataxia-teleangiectasia…) • ALL diagnosed as second malignancy and preceding chemotherapy and/or radiotherapy • evidence of pregnancy or lactation period • Sexually active adolescents not willing to use highly effective contraceptive method (pearl index \<1) until 12 months after end of anti-leukemic therapy • participation in another clinical trial except for add-on trials within the scope of supportive care approved by the sponsor • live vaccine immunization within 2 weeks before start of protocol treatment
Contacts
Les coordonnées de l'équipe de l'essai s'affichent sur demande.
Voir la fiche officielle de l'essai- Statut
- Recrutement en cours
- Phase
- Phase 3
- Type d'étude
- Interventionnelle
- Pays
- Suisse, Allemagne, Italie, Autriche, Australie, Tchéquie, Israël, Slovaquie
- Promoteur
- Martin Schrappe(Autre)
- N° de protocole
- AIEOP-BFM ALL 2017
- Pathologies
- Acute Lymphoblastic Leukemia, Pediatric
- Interventions
- Médicament
Traitements évalués
- Blinatumomab
- Bortezomib
- Cyclophosphamide
- Cytarabine
- Daunorubicin
- Myocet
- Dexamethasone
- Doxorubicin
- Etoposide
- Fludarabine Phosphate
- Ifosfamide
- 6-Mercaptopurine
- Methotrexate
- Pegaspargase
- Prednisolone
- Tioguanin
- Vincristine
- Vindesine
- Erwinase
Collaborateurs
Deutsche Krebshilfe e.V., Bonn (Germany)
Lieux · 115
- Aarau, SuisseKantonsspital AarauRecrute dans ce centre
- Basel, SuisseUniversitäts-Kinderspital beider BaselRecrute dans ce centre
- Bellinzona, SuisseOspedale San Giovanni BellinzonaRecrute dans ce centre
- Bern, SuisseInselspital BernRecrute dans ce centre
- Geneva, SuisseHUG Hôpitaux Universitaires de GèneveRecrute dans ce centre
- Lausanne, SuisseCHUV Centre Hospitalier Universitaire VaudoisRecrute dans ce centre
- Lucerne, SuisseLuzerner Kantonsspital-Kinderspital LuzernRecrute dans ce centre
- Sankt Gallen, SuisseOstschweizer KinderspitalRecrute dans ce centre
- Zurich, SuisseUniversitäts-Kinderspital ZürichRecrute dans ce centre
- Aachen, AllemagneKinderklinik der med. Fakultät der RWTH, Bereich Hämatologie/OnkologieRecrute dans ce centre
- Augsburg, AllemagneI. Klinik für Kinder u. Jugendliche, Klinikum Augsburg, Hämatologie/ OnkologieRecrute dans ce centre
- Berlin, AllemagneKlinikum Berlin-Buch II. Kinderklinik, Bereich Onkologie/Allg. PädiatrieRecrute dans ce centre
- Berlin, AllemagneKinderklinik der Charité, Campus Virchow Klinikum (CVK), Abt.: KinderhämatologieRecrute dans ce centre
- Braunschweig, AllemagneStädtisches Krankenhaus, KinderklinikRecrute dans ce centre
- Chemnitz, AllemagneKlinikum Chemnitz gGmbH, Klinik für Kinder- und Jugendmedizin, Hämatologie / OnkologieRecrute dans ce centre
- Cologne, AllemagneKliniken der Stadt Köln GmbH, Kinderkrankenhaus RiehlRecrute dans ce centre
- Cologne, AllemagneMed. Einrichtungen der Universität zu Köln, Klinik für Allg. Kinderheilkunde, Onkologisch-hämatologische StationRecrute dans ce centre
- Cottbus, AllemagneCarl-Thiem-Klinikum, Kinderklinik, Abt. Hämatologie/OnkologieRecrute dans ce centre
- Datteln, AllemagneVestische Kinder- u. Jugendklinik, Universitätsklinik Witten/HerdeckeRecrute dans ce centre
- Dortmund, AllemagneKlinikum Dortmund, Klinik f. Kinder- und JugendmedizinRecrute dans ce centre
- Dresden, AllemagneUniversitatsklinikum Carl Gustav CarusRecrute dans ce centre
- Düsseldorf, AllemagneUniversitätsklinikRecrute dans ce centre
- Erfurt, AllemagneHelios Klinikum Erfurt GmbH, Klinik für KinderheilkundeRecrute dans ce centre
- Erlangen, AllemagneUniversitaets - KinderklinikRecrute dans ce centre
- Essen, AllemagneUniversitaetsklinikum EssenRecrute dans ce centre
- Frankfurt, AllemagneKlinikum der J.W. Goethe UniversitaetRecrute dans ce centre
- Freiburg im Breisgau, AllemagneUniversitaetskinderklinik - Universitaetsklinikum FreiburgRecrute dans ce centre
- Giessen, AllemagneKlinikum der Justus-Liebig-Universität, Zentrum für Kinderheilkunde, Abt. Hämatologie/OnkologieRecrute dans ce centre
- Göttingen, AllemagneUniversitäts-Kinderklinik Päd. I, Hämatologie/OnkologieRecrute dans ce centre
- Greifswald, AllemagneKlinik und Poliklinik für Kinder und Jugendmedizin, Allgemeine Pädiatrie mit Poliklinik/Pädiatrische Onkologie und HämatologieRecrute dans ce centre
Au total, dans le monde, les 115 centres listés au registre recrutent.
Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 6 avril 2025).
Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.
+ 85 autres lieux
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Autres versions
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