NCT03643276Recruiting
Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017
Summary
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.
Inclusion criteria
• 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.
Exclusion criteria
• 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
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Countries
- Switzerland, Germany, Italy, Austria, Australia, Czechia, Israel, Slovakia
- Sponsor
- Martin Schrappe(Other)
- Protocol no.
- AIEOP-BFM ALL 2017
- Conditions
- Acute Lymphoblastic Leukemia, Pediatric
- Interventions
- Drug
Treatments studied
- Blinatumomab
- Bortezomib
- Cyclophosphamide
- Cytarabine
- Daunorubicin
- Myocet
- Dexamethasone
- Doxorubicin
- Etoposide
- Fludarabine Phosphate
- Ifosfamide
- 6-Mercaptopurine
- Methotrexate
- Pegaspargase
- Prednisolone
- Tioguanin
- Vincristine
- Vindesine
- Erwinase
Collaborators
Deutsche Krebshilfe e.V., Bonn (Germany)
Locations · 115
- Aarau, SwitzerlandKantonsspital AarauRecruiting at this site
- Basel, SwitzerlandUniversitäts-Kinderspital beider BaselRecruiting at this site
- Bellinzona, SwitzerlandOspedale San Giovanni BellinzonaRecruiting at this site
- Bern, SwitzerlandInselspital BernRecruiting at this site
- Geneva, SwitzerlandHUG Hôpitaux Universitaires de GèneveRecruiting at this site
- Lausanne, SwitzerlandCHUV Centre Hospitalier Universitaire VaudoisRecruiting at this site
- Lucerne, SwitzerlandLuzerner Kantonsspital-Kinderspital LuzernRecruiting at this site
- Sankt Gallen, SwitzerlandOstschweizer KinderspitalRecruiting at this site
- Zurich, SwitzerlandUniversitäts-Kinderspital ZürichRecruiting at this site
- Aachen, GermanyKinderklinik der med. Fakultät der RWTH, Bereich Hämatologie/OnkologieRecruiting at this site
- Augsburg, GermanyI. Klinik für Kinder u. Jugendliche, Klinikum Augsburg, Hämatologie/ OnkologieRecruiting at this site
- Berlin, GermanyKlinikum Berlin-Buch II. Kinderklinik, Bereich Onkologie/Allg. PädiatrieRecruiting at this site
- Berlin, GermanyKinderklinik der Charité, Campus Virchow Klinikum (CVK), Abt.: KinderhämatologieRecruiting at this site
- Braunschweig, GermanyStädtisches Krankenhaus, KinderklinikRecruiting at this site
- Chemnitz, GermanyKlinikum Chemnitz gGmbH, Klinik für Kinder- und Jugendmedizin, Hämatologie / OnkologieRecruiting at this site
- Cologne, GermanyKliniken der Stadt Köln GmbH, Kinderkrankenhaus RiehlRecruiting at this site
- Cologne, GermanyMed. Einrichtungen der Universität zu Köln, Klinik für Allg. Kinderheilkunde, Onkologisch-hämatologische StationRecruiting at this site
- Cottbus, GermanyCarl-Thiem-Klinikum, Kinderklinik, Abt. Hämatologie/OnkologieRecruiting at this site
- Datteln, GermanyVestische Kinder- u. Jugendklinik, Universitätsklinik Witten/HerdeckeRecruiting at this site
- Dortmund, GermanyKlinikum Dortmund, Klinik f. Kinder- und JugendmedizinRecruiting at this site
- Dresden, GermanyUniversitatsklinikum Carl Gustav CarusRecruiting at this site
- Düsseldorf, GermanyUniversitätsklinikRecruiting at this site
- Erfurt, GermanyHelios Klinikum Erfurt GmbH, Klinik für KinderheilkundeRecruiting at this site
- Erlangen, GermanyUniversitaets - KinderklinikRecruiting at this site
- Essen, GermanyUniversitaetsklinikum EssenRecruiting at this site
- Frankfurt, GermanyKlinikum der J.W. Goethe UniversitaetRecruiting at this site
- Freiburg im Breisgau, GermanyUniversitaetskinderklinik - Universitaetsklinikum FreiburgRecruiting at this site
- Giessen, GermanyKlinikum der Justus-Liebig-Universität, Zentrum für Kinderheilkunde, Abt. Hämatologie/OnkologieRecruiting at this site
- Göttingen, GermanyUniversitäts-Kinderklinik Päd. I, Hämatologie/OnkologieRecruiting at this site
- Greifswald, GermanyKlinik und Poliklinik für Kinder und Jugendmedizin, Allgemeine Pädiatrie mit Poliklinik/Pädiatrische Onkologie und HämatologieRecruiting at this site
In total, worldwide, all 115 sites listed in the registry are recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: April 6, 2025).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 85 more locations
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.