Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017

PHASE3RecruitingINTERVENTIONAL
Enrollment

5,000

Participants

Timeline

Start Date

July 15, 2018

Primary Completion Date

July 14, 2028

Study Completion Date

July 14, 2028

Conditions
Acute Lymphoblastic Leukemia, Pediatric
Interventions
DRUG

Blinatumomab

Experimental therapy in randomizations R-HR and R-MR

DRUG

Bortezomib

Experimental therapy in randomization R-eHR

DRUG

Cyclophosphamide

Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T

DRUG

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

DRUG

Daunorubicin

Part of standard chemotherapy

DRUG

Myocet

Part of intensification block Myocet-FLA for patients with very high relapse risk

DRUG

Dexamethasone

Part of standard chemotherapy

DRUG

Doxorubicin

Part of standard chemotherapy

DRUG

Etoposide

Part of standard chemotherapy

DRUG

Fludarabine Phosphate

Part of intensification block Myocet-FLA for patients with very high relapse risk

DRUG

Ifosfamide

Part of standard chemotherapy

DRUG

6-Mercaptopurine

Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T

DRUG

Methotrexate

Part of standard chemotherapy

DRUG

Pegaspargase

Part of standard chemotherapy

DRUG

Prednisolone

Part of standard chemotherapy

DRUG

Tioguanin

Part of standard chemotherapy

DRUG

Vincristine

Part of standard chemotherapy

DRUG

Vindesine

Part of standard chemotherapy

DRUG

Erwinase

Part of standard chemotherapy as substitute for PEG-L-Asparaginase in case of allergic reaction

Trial Locations (115)

7740

RECRUITING

Klinikum, der Friedrich-Schiller-Universität, Klinik für Kinder- und Jugendmedizin, Jena

13125

RECRUITING

Klinikum Berlin-Buch II. Kinderklinik, Bereich Onkologie/Allg. Pädiatrie, Berlin

13353

RECRUITING

Kinderklinik der Charité, Campus Virchow Klinikum (CVK), Abt.: Kinderhämatologie, Berlin

17475

RECRUITING

Klinik und Poliklinik für Kinder und Jugendmedizin, Allgemeine Pädiatrie mit Poliklinik/Pädiatrische Onkologie und Hämatologie, Greifswald

18055

RECRUITING

Universitäts-Kinderklinik, Rostock

19049

RECRUITING

HELIOS Kliniken Schwerin, Klinik f. Kinder-u. Jugendmedizin, Schwerin

23538

RECRUITING

Universität zu Lübeck, Klinik für Kinder- u. Jugendmedizin, Abt. Hämatologie/ Onkologie/Immunologie, Lübeck

24105

RECRUITING

Klinik für Allgemeine Paediatrie, Univ.-Klinikum Schleswig-Holstein, Campus Kiel, Kiel

26133

RECRUITING

Klinikum Oldenburg gGmbH, Zentrum für Kinder- u. Jugendmedizin, (Elisabeth Kinderkrankenhaus), Oldenburg

30625

RECRUITING

Medizinische Hochschule Hannover, Zentrum Kinderheilkunde u. Jugendmedizin, Hanover

32429

RECRUITING

Johannes Wesling Klinikum Minden, Minden

35385

RECRUITING

Klinikum der Justus-Liebig-Universität, Zentrum für Kinderheilkunde, Abt. Hämatologie/Onkologie, Giessen

37099

RECRUITING

Universitäts-Kinderklinik Päd. I, Hämatologie/Onkologie, Göttingen

38118

RECRUITING

Städtisches Krankenhaus, Kinderklinik, Braunschweig

38440

RECRUITING

Stadtkrankenhaus, Kinderklinik, Wolfsburg

39120

RECRUITING

Universitätsklinikum Magdeburg, Klinik für Päd. Hämatologie/Onkologie, Magdeburg

44137

RECRUITING

Klinikum Dortmund, Klinik f. Kinder- und Jugendmedizin, Dortmund

45711

RECRUITING

Vestische Kinder- u. Jugendklinik, Universitätsklinik Witten/Herdecke, Datteln

48149

RECRUITING

Universitäts-Kinderklinik, Päd. Hämatologie und Onkologie, Münster

50735

RECRUITING

Kliniken der Stadt Köln GmbH, Kinderkrankenhaus Riehl, Cologne

50937

RECRUITING

Med. Einrichtungen der Universität zu Köln, Klinik für Allg. Kinderheilkunde, Onkologisch-hämatologische Station, Cologne

52074

RECRUITING

Kinderklinik der med. Fakultät der RWTH, Bereich Hämatologie/Onkologie, Aachen

53757

RECRUITING

Asklepios-Klinik, Sankt Augustin GmbH, Sankt Augustin

54290

RECRUITING

Krankenanstalt Trier, Mutterhaus der Borromaeerinnen, Pädiatrische Abteilung, Trier

58313

RECRUITING

Gemeinschaftskrankenhaus Herdecke, Kinderabteilung, Herdecke

66421

RECRUITING

Universitaetsklinikum des Saarlandes, Homburg

68167

RECRUITING

Klinikum Mannheim gGmbH, Kinderklinik, Abt. Hämatologie/Onkologie, Mannheim

69120

RECRUITING

Universitäts-Kinderklinik, Päd. Onkologie, Hämatologie, und Immunologie, Heidelberg

70176

RECRUITING

Olga-Hospital, Kinderklinik, Pädiatrisches Zentrum, Abt. Hämatologie/Onkologie, Stuttgart

74078

RECRUITING

Klinikum Heilbronn GmbH, Klinik für Kinderheilkunde und Jugendmedizin/Perinatalzentrum, Heilbronn

76133

RECRUITING

Staedtisches Klinikum Karlsruhe gGmbH, Karlsruhe

80804

RECRUITING

Städt. Krankenhaus München GmbH, Krankenhaus München-Schwabingen, Kinderklinik d. TU, München

86156

RECRUITING

I. Klinik für Kinder u. Jugendliche, Klinikum Augsburg, Hämatologie/ Onkologie, Augsburg

90419

RECRUITING

Cnopf'sche Kinderklinik, Onkologie, Nuremberg

91054

RECRUITING

Universitaets - Kinderklinik, Erlangen

99089

RECRUITING

Helios Klinikum Erfurt GmbH, Klinik für Kinderheilkunde, Erfurt

Unknown

RECRUITING

Sydney Children's Hospital, Sydney

RECRUITING

The Children's Hospital at Westmead, Westmead

RECRUITING

Univ.Klinik für Kinder- und Jugendheilkunde Graz, Graz

RECRUITING

Univ.Klinik für Kinder- und Jugendheilkunde Innsbruck, Innsbruck

RECRUITING

Kepler Universitätsklinikum, Linz

RECRUITING

LKH Salzburg, Salzburg

RECRUITING

St. Anna Kinderspital, Vienna

RECRUITING

University Hospital Brno, Brno

RECRUITING

Regional Hospital České Budějovice, České Budějovice

RECRUITING

University Hospital Hradec Králové, Hradec Králové

RECRUITING

University Hospital Olomouc, Olomouc

RECRUITING

University Hospital Ostrava-Poruba, Ostrava-Poruba

RECRUITING

University Hospital Plzeň, Pilsen

RECRUITING

University Hospital Motol, Prague

RECRUITING

Masaryk´s Hospital Ústí nad Labem, Ústí nad Labem

RECRUITING

Universitätsklinik, Düsseldorf

RECRUITING

Universitätsklinikum, Mannheim

RECRUITING

Ludwig-Maximilian-Universität, Dr. von Haunersches Kinderspital, München

RECRUITING

Universitätsklinikum, Regensburg

RECRUITING

Soroka University Medical Center, Beersheba

RECRUITING

Rambam Health Care Campus, Haifa

RECRUITING

Hadassah Medical center, Jerusalem

RECRUITING

Schneider Children Medical Center of Israel, Petah Tikva

RECRUITING

Sheba Medical Center Tel-Hashomer, Ramat Gan

RECRUITING

Dana children hospital, Tel Aviv

RECRUITING

Azienda ospedali riuniti, Ancona

RECRUITING

AOUC Policlinico Bari, Bari

RECRUITING

A.O. Papa Giovanni XXIII, Bergamo

RECRUITING

Università di Bologna, Bologna

RECRUITING

ASST Spedali Civili di Brescia, Brescia

RECRUITING

Ospedale Businco, Cagliari

RECRUITING

Azienda ospedaliero universitaria, Catania

RECRUITING

AO Pugliese Ciaccio, Catanzaro

RECRUITING

S.O. Annunziata - A. O. Cosenza, Cosenza

RECRUITING

Ospedale Meyer, Florence

RECRUITING

Istituto Giannina Gaslini, Genova

RECRUITING

Policlinico di Modena Azienda Ospedaliero-Universitaria, Modena

RECRUITING

Clinica pediatrica Fondazione MBBM, Monza

RECRUITING

A.O.U. Vanvitelli, Napoli

RECRUITING

AORN Santobono Pausilipon, Napoli

RECRUITING

Azienda ospedaliera di Padova, Padua

RECRUITING

Ospedale Civico ARNAS Civico e Di Cristina, Palermo

RECRUITING

Azienda ospedaliero-universitaria di Parma, Parma

RECRUITING

Fondazione IRCCS Policlinico San Matteo, Pavia

RECRUITING

Ospedale S. Maria della misericordia, Perugia

RECRUITING

Ospedale Civile di Pescara, Pescara

RECRUITING

Ospedale Santa Chiara Pisa, Pisa

RECRUITING

Grande ospedale metropolitano B-M-M, Reggio Calabria

RECRUITING

Ospedale infermi, Rimini

RECRUITING

Fondazione Policlinico Gemelli, Roma

RECRUITING

Ospedale Bambino Gesù, Roma

RECRUITING

Policlinico Umberto I Università Sapienza di Roma, Roma

RECRUITING

"Ospedale Casa sollievo della sofferenza", San Giovanni Rotondo

RECRUITING

A.O.U. Città della salute e della scienza di Torino, Torino

RECRUITING

IRCCS Burlo Garofolo, Trieste

RECRUITING

AOU Verona, Verona

RECRUITING

Klinika pediatrickej hematológie a onkológie SZU a DFNsP, Banská Bystrica

RECRUITING

Comenius University Children's Hospital, Bratislava

RECRUITING

Detská fakultná nemocnica Košice, Košice

RECRUITING

Kantonsspital Aarau, Aarau

RECRUITING

Universitäts-Kinderspital beider Basel, Basel

RECRUITING

Ospedale San Giovanni Bellinzona, Bellinzona

RECRUITING

Inselspital Bern, Bern

RECRUITING

HUG Hôpitaux Universitaires de Gèneve, Geneva

RECRUITING

CHUV Centre Hospitalier Universitaire Vaudois, Lausanne

RECRUITING

Luzerner Kantonsspital-Kinderspital Luzern, Lucerne

RECRUITING

Ostschweizer Kinderspital, Sankt Gallen

RECRUITING

Universitäts-Kinderspital Zürich, Zurich

09009

RECRUITING

Klinikum Chemnitz gGmbH, Klinik für Kinder- und Jugendmedizin, Hämatologie / Onkologie, Chemnitz

03048

RECRUITING

Carl-Thiem-Klinikum, Kinderklinik, Abt. Hämatologie/Onkologie, Cottbus

D-01307

RECRUITING

Universitatsklinikum Carl Gustav Carus, Dresden

D-45147

RECRUITING

Universitaetsklinikum Essen, Essen

D-60590

RECRUITING

Klinikum der J.W. Goethe Universitaet, Frankfurt

D-79106

RECRUITING

Universitaetskinderklinik - Universitaetsklinikum Freiburg, Freiburg im Breisgau

D-34125

RECRUITING

Klinikum Kassel, Kassel

04103

RECRUITING

Department für Frauen- und Kindermedizin, Abteilung für Pädiatrische Onkologie, Hämatologie und Hämostaseologie, Leipzig

D-72076

RECRUITING

Universitaetsklinikum Tuebingen, Tübingen

D-89075

RECRUITING

Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm, Ulm

D-97080

RECRUITING

Universitaets - Kinderklinik Wuerzburg, Würzburg

All Listed Sponsors
collaborator

Deutsche Krebshilfe e.V., Bonn (Germany)

OTHER

lead

Martin Schrappe

OTHER