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Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017
Sponsor: Martin Schrappe
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.
Official title: International Collaborative Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017
Key Details
Gender
All
Age Range
Any - 17 Years
Study Type
INTERVENTIONAL
Enrollment
5000
Start Date
2018-07-15
Completion Date
2028-07-14
Last Updated
2025-04-06
Healthy Volunteers
No
Conditions
Interventions
Blinatumomab
Experimental therapy in randomizations R-HR and R-MR
Bortezomib
Experimental therapy in randomization R-eHR
Cyclophosphamide
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T
Cytarabine
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T and in the intensification block Myocet-FLA for patients with very high relapse risk
Daunorubicin
Part of standard chemotherapy
Myocet
Part of intensification block Myocet-FLA for patients with very high relapse risk
Dexamethasone
Part of standard chemotherapy
Doxorubicin
Part of standard chemotherapy
Etoposide
Part of standard chemotherapy
Fludarabine Phosphate
Part of intensification block Myocet-FLA for patients with very high relapse risk
Ifosfamide
Part of standard chemotherapy
6-Mercaptopurine
Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T
Methotrexate
Part of standard chemotherapy
Pegaspargase
Part of standard chemotherapy
Prednisolone
Part of standard chemotherapy
Tioguanin
Part of standard chemotherapy
Vincristine
Part of standard chemotherapy
Vindesine
Part of standard chemotherapy
Erwinase
Part of standard chemotherapy as substitute for PEG-L-Asparaginase in case of allergic reaction
Locations (115)
Sydney Children's Hospital
Sydney, Australia
The Children's Hospital at Westmead
Westmead, Australia
Univ.Klinik für Kinder- und Jugendheilkunde Graz
Graz, Austria
Univ.Klinik für Kinder- und Jugendheilkunde Innsbruck
Innsbruck, Austria
Kepler Universitätsklinikum
Linz, Austria
LKH Salzburg
Salzburg, Austria
St. Anna Kinderspital
Vienna, Austria
University Hospital Brno
Brno, Czechia
Regional Hospital České Budějovice
České Budějovice, Czechia
University Hospital Hradec Králové
Hradec Králové, Czechia
University Hospital Olomouc
Olomouc, Czechia
University Hospital Ostrava-Poruba
Ostrava-Poruba, Czechia
University Hospital Plzeň
Pilsen, Czechia
University Hospital Motol
Prague, Czechia
Masaryk´s Hospital Ústí nad Labem
Ústí nad Labem, Czechia
Kinderklinik der med. Fakultät der RWTH, Bereich Hämatologie/Onkologie
Aachen, Germany
I. Klinik für Kinder u. Jugendliche, Klinikum Augsburg, Hämatologie/ Onkologie
Augsburg, Germany
Klinikum Berlin-Buch II. Kinderklinik, Bereich Onkologie/Allg. Pädiatrie
Berlin, Germany
Kinderklinik der Charité, Campus Virchow Klinikum (CVK), Abt.: Kinderhämatologie
Berlin, Germany
Städtisches Krankenhaus, Kinderklinik
Braunschweig, Germany
Klinikum Chemnitz gGmbH, Klinik für Kinder- und Jugendmedizin, Hämatologie / Onkologie
Chemnitz, Germany
Kliniken der Stadt Köln GmbH, Kinderkrankenhaus Riehl
Cologne, Germany
Med. Einrichtungen der Universität zu Köln, Klinik für Allg. Kinderheilkunde, Onkologisch-hämatologische Station
Cologne, Germany
Carl-Thiem-Klinikum, Kinderklinik, Abt. Hämatologie/Onkologie
Cottbus, Germany
Vestische Kinder- u. Jugendklinik, Universitätsklinik Witten/Herdecke
Datteln, Germany
Klinikum Dortmund, Klinik f. Kinder- und Jugendmedizin
Dortmund, Germany
Universitatsklinikum Carl Gustav Carus
Dresden, Germany
Universitätsklinik
Düsseldorf, Germany
Helios Klinikum Erfurt GmbH, Klinik für Kinderheilkunde
Erfurt, Germany
Universitaets - Kinderklinik
Erlangen, Germany
Universitaetsklinikum Essen
Essen, Germany
Klinikum der J.W. Goethe Universitaet
Frankfurt, Germany
Universitaetskinderklinik - Universitaetsklinikum Freiburg
Freiburg im Breisgau, Germany
Klinikum der Justus-Liebig-Universität, Zentrum für Kinderheilkunde, Abt. Hämatologie/Onkologie
Giessen, Germany
Universitäts-Kinderklinik Päd. I, Hämatologie/Onkologie
Göttingen, Germany
Klinik und Poliklinik für Kinder und Jugendmedizin, Allgemeine Pädiatrie mit Poliklinik/Pädiatrische Onkologie und Hämatologie
Greifswald, Germany
Medizinische Hochschule Hannover, Zentrum Kinderheilkunde u. Jugendmedizin
Hanover, Germany
Universitäts-Kinderklinik, Päd. Onkologie, Hämatologie, und Immunologie
Heidelberg, Germany
Klinikum Heilbronn GmbH, Klinik für Kinderheilkunde und Jugendmedizin/Perinatalzentrum
Heilbronn, Germany
Gemeinschaftskrankenhaus Herdecke, Kinderabteilung
Herdecke, Germany
Universitaetsklinikum des Saarlandes
Homburg, Germany
Klinikum, der Friedrich-Schiller-Universität, Klinik für Kinder- und Jugendmedizin
Jena, Germany
Staedtisches Klinikum Karlsruhe gGmbH
Karlsruhe, Germany
Klinikum Kassel
Kassel, Germany
Klinik für Allgemeine Paediatrie, Univ.-Klinikum Schleswig-Holstein, Campus Kiel
Kiel, Germany
Department für Frauen- und Kindermedizin, Abteilung für Pädiatrische Onkologie, Hämatologie und Hämostaseologie
Leipzig, Germany
Universität zu Lübeck, Klinik für Kinder- u. Jugendmedizin, Abt. Hämatologie/ Onkologie/Immunologie
Lübeck, Germany
Universitätsklinikum Magdeburg, Klinik für Päd. Hämatologie/Onkologie
Magdeburg, Germany
Klinikum Mannheim gGmbH, Kinderklinik, Abt. Hämatologie/Onkologie
Mannheim, Germany
Universitätsklinikum
Mannheim, Germany
Johannes Wesling Klinikum Minden
Minden, Germany
Städt. Krankenhaus München GmbH, Krankenhaus München-Schwabingen, Kinderklinik d. TU
München, Germany
Ludwig-Maximilian-Universität, Dr. von Haunersches Kinderspital
München, Germany
Universitäts-Kinderklinik, Päd. Hämatologie und Onkologie
Münster, Germany
Cnopf'sche Kinderklinik, Onkologie
Nuremberg, Germany
Klinikum Oldenburg gGmbH, Zentrum für Kinder- u. Jugendmedizin, (Elisabeth Kinderkrankenhaus)
Oldenburg, Germany
Universitätsklinikum
Regensburg, Germany
Universitäts-Kinderklinik
Rostock, Germany
Asklepios-Klinik, Sankt Augustin GmbH
Sankt Augustin, Germany
HELIOS Kliniken Schwerin, Klinik f. Kinder-u. Jugendmedizin
Schwerin, Germany
Olga-Hospital, Kinderklinik, Pädiatrisches Zentrum, Abt. Hämatologie/Onkologie
Stuttgart, Germany
Krankenanstalt Trier, Mutterhaus der Borromaeerinnen, Pädiatrische Abteilung
Trier, Germany
Universitaetsklinikum Tuebingen
Tübingen, Germany
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
Ulm, Germany
Stadtkrankenhaus, Kinderklinik
Wolfsburg, Germany
Universitaets - Kinderklinik Wuerzburg
Würzburg, Germany
Soroka University Medical Center
Beersheba, Israel
Rambam Health Care Campus
Haifa, Israel
Hadassah Medical center
Jerusalem, Israel
Schneider Children Medical Center of Israel
Petah Tikva, Israel
Sheba Medical Center Tel-Hashomer
Ramat Gan, Israel
Dana children hospital
Tel Aviv, Israel
Azienda ospedali riuniti
Ancona, Italy
AOUC Policlinico Bari
Bari, Italy
A.O. Papa Giovanni XXIII
Bergamo, Italy
Università di Bologna
Bologna, Italy
ASST Spedali Civili di Brescia
Brescia, Italy
Ospedale Businco
Cagliari, Italy
Azienda ospedaliero universitaria
Catania, Italy
AO Pugliese Ciaccio
Catanzaro, Italy
S.O. Annunziata - A. O. Cosenza
Cosenza, Italy
Ospedale Meyer
Florence, Italy
Istituto Giannina Gaslini
Genova, Italy
Policlinico di Modena Azienda Ospedaliero-Universitaria
Modena, Italy
Clinica pediatrica Fondazione MBBM
Monza, Italy
A.O.U. Vanvitelli
Naples, Italy
AORN Santobono Pausilipon
Naples, Italy
Azienda ospedaliera di Padova
Padova, Italy
Ospedale Civico ARNAS Civico e Di Cristina
Palermo, Italy
Azienda ospedaliero-universitaria di Parma
Parma, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Ospedale S. Maria della misericordia
Perugia, Italy
Ospedale Civile di Pescara
Pescara, Italy
Ospedale Santa Chiara Pisa
Pisa, Italy
Grande ospedale metropolitano B-M-M
Reggio Calabria, Italy
Ospedale infermi
Rimini, Italy
Fondazione Policlinico Gemelli
Roma, Italy
Ospedale Bambino Gesù
Roma, Italy
Policlinico Umberto I Università Sapienza di Roma
Roma, Italy
Ospedale "Casa sollievo della sofferenza"
San Giovanni Rotondo, Italy
A.O.U. Città della salute e della scienza di Torino
Torino, Italy
IRCCS Burlo Garofolo
Trieste, Italy
AOU Verona
Verona, Italy
Klinika pediatrickej hematológie a onkológie SZU a DFNsP
Banská Bystrica, Slovakia
Comenius University Children's Hospital
Bratislava, Slovakia
Detská fakultná nemocnica Košice
Košice, Slovakia
Kantonsspital Aarau
Aarau, Switzerland
Universitäts-Kinderspital beider Basel
Basel, Switzerland
Ospedale San Giovanni Bellinzona
Bellinzona, Switzerland
Inselspital Bern
Bern, Switzerland
HUG Hôpitaux Universitaires de Gèneve
Geneva, Switzerland
CHUV Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
Luzerner Kantonsspital-Kinderspital Luzern
Lucerne, Switzerland
Ostschweizer Kinderspital
Sankt Gallen, Switzerland
Universitäts-Kinderspital Zürich
Zurich, Switzerland