International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma (LBL 2018)

June 7, 2021 updated by: University Hospital Muenster

LBL 2018 - International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma

Primary objectives:

Randomization R1, all patients eligible: To examine, whether the cumulative incidence of relapses with involvement of the CNS (CNS relapse, pCICR) can be decreased by a modified induction therapy including dexamethasone (experimental arm) instead of prednisone (standard arm)
Randomization R2, only patients with high risk LBL eligible: to examine, whether the probability of event-free survival (pEFS) in these patients can be improved by receiving an intensified treatment arm versus a standard treatment arm (as used in the EURO-LB 02)

Study Overview

Status

Recruiting

Conditions

Lymphoblastic Lymphoma, Childhood

Intervention / Treatment

Detailed Description

The trial LBL 2018 is a collaborative prospective, multi-national, multi-center, randomized clinical trial for the treatment of children and adolescents with newly diagnosed lymphoblastic lymphoma.

The LBL 2018 trial will be open for the qualified centers of following participating study Groups (core study cohort): AIEOP (Italy), BFM (Austria, Czech Republic, Germany, Switzerland), BSPHO (Belgium), CoALL (Germany), DCOG (The Netherlands), NOPHO (Denmark, Finland, Norway, Sweden), PPLSG (Poland), SEHOP (Spain) and SFCE (France). HKPHOSG (Hong Kong), HPOG (Hungary), ISPHO (Israel), NSPHO (Moscow), PHOAI (Ireland), SHOP (Portugal) and SPS (Slovak Republic) start patient recruitment into the extended study cohort (without randomization). Over the trial period study groups may switch from the extended study cohort to the core study cohort.

Primary objectives:

Randomization R1, all patients eligible: To examine, whether the cumulative incidence of relapses with involvement of the CNS (CNS relapse, pCICR) can be decreased by a modified induction therapy including dexamethasone (experimental arm) instead of prednisone (standard arm)
Randomization R2, only patients with high risk LBL eligible: to examine, whether the probability of event-free survival (pEFS) in these patients can be improved by receiving an intensified treatment arm versus a standard treatment arm (as used in the EURO-LB 02)

Patients are stratified into 3 different risk groups according to CNS status, immunophenotype, genetic markers and stage of disease at diagnosis: high risk group (HR), standard risk group I/II (SR I/II) and standard risk group (SR).

Patients in the risk groups SR I/II and SR are randomized (R1) in two arms after a cytoreductive prephase with prednisone. Patients in standard arm receive the standard induction phase with prednisone. Patients in the experimental arm receive an induction phase with dexamethasone instead of prednisone.

In SR group, induction phase is followed by the consolidation phase, the non-HR extra-compartment phase with HD-MTX (high-dose methotrexate), the reintensification phase and the maintenance therapy for the total therapy duration of 24 months. In SR I/II group, patients receive no reintensification phase. The Induction phase is followed by the consolidation phase, the non-HR extra-compartment phase and the maintenance therapy for the total therapy duration of 24 months.

Patients in the HR group are eligible for randomization (R1) as outlined above. In addition high risk patients are eligible for second randomization (R2) at the end of induction phase. In the standard arm, HR-patients receive the consolidation phase and the non-HR extra-compartment phase. In the experimental arm, HR-patients receive a consolidation phase including two additional doses of PEG asparaginase and the HR-intensified extra-compartment phase consisting of two high risk courses alternating with two HD-MTX courses. Either phase is followed by the reintensification phase and the maintenance therapy for the total therapy duration of 24 months.

Patients with involvement of the CNS (CNS positive) are stratified to the high risk group (HR) and are eligible for both randomizations (R1 and R2). Additionally, patients with CNS involvement (CNS positive) receive intensified intrathecal therapy. Intrathecal therapy consists of TIT (triple intrathecal therapy) after diagnosis of CNS involvement. TIT is administered twice weekly until clearance of blasts in the cerebrospinal fluid is achieved. Further intrathecal therapy is provided at the same points of time as for patients without CNS involvement, but TIT instead of MTX IT. In addition, patients receive four additional doses of TIT during maintenance. Cranial irradiation is omitted for patients with CNS involvement.

Study Type

Interventional

Enrollment (Anticipated)

683

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Birgit Burkhardt, Prof. Dr. Dr.
Phone Number: +49 251 83 55696
Email: LBL2018@ukmuenster.de

Study Locations

Austria
- - Graz, Austria, 8036
    - Recruiting
    - Univ.Klinik für Kinder- und Jugendheilkunde Graz, Klin. Abteilung für pädiatrische Hämato-Onkologie
  - Innsbruck, Austria, 6020
    - Recruiting
    - Univ.Klinik für Kinder- und Jugendheilkunde Innsbruck, Universitätsklinik für Pädiatrie I
  - Linz, Austria, 4020
    - Recruiting
    - Kepler Universitätsklinikum, Med Campus IV / Onkologie
  - Salzburg, Austria, 5020
    - Recruiting
    - LKH Salzburg, Universitätsklinik für Kinder- und Jugendheilkunde, Kinderonkologie
  - Wien, Austria, 1090
    - Recruiting
    - St. Anna Kinderspital
Belgium
- - Brussel, Belgium, 1090
    - Recruiting
    - University Hospital Brussels, Pediatrische oncologie
  - Brussel, Belgium, 1200
    - Recruiting
    - Cliniques Universitaires Saint-Luc (UCL), Hématologie et oncologie pédiatrique
  - Brussels, Belgium, 1020
    - Recruiting
    - Hôpital Universitaire des Enfants Reine Fabiola (ULB), Pédiatrie hémato-oncologie
  - Edegem, Belgium, 2650
    - Recruiting
    - UZ Antwerpen Kinderhemato-oncologie
  - Gent, Belgium, 9000
    - Recruiting
    - University Hospital Gent Pediatrische hemato-oncologie
  - Leuven, Belgium, 3000
    - Recruiting
    - University Hospitals Leuven, Kinderhemato-oncologie
  - Liège, Belgium, 4000
    - Recruiting
    - CHR Citadelle Hémato - oncologie pédiatrique
  - Montegnée, Belgium, 4000
    - Recruiting
    - CHR Citadelle Hémato - oncologie pédiatrique
China
- - Hong Kong, China
    - Not yet recruiting
    - Hong Kong Children's Hospital
Czechia
- - Brno, Czechia, 662 63
    - Recruiting
    - Dept. of Pediatric Oncology, University Hospital Brno and Faculty of Medicine, Masaryk University Cernopolni
  - Praha, Czechia, 160 06
    - Recruiting
    - Dept. of Pediatric Hematology and Oncology. University Hospital Motol and 2nd Medical School, Charles University
Denmark
- - Aalborg, Denmark, 9000
    - Recruiting
    - University Hospital Aalborg, Nord, Department of Pediatrics
  - Aarhus, Denmark, 8200
    - Recruiting
    - Aarhus University Hospital, Department of Pediatrics
  - Kobenhavn, Denmark, 2100 Ø
    - Recruiting
    - Børneonkologisk afsnit 5054, BørneUngeKlinikken, Juliane Marie Centret, Rigshospitalet
  - Odense, Denmark, 5000
    - Recruiting
    - H.C. Andersens Children Hospital, Odense University Hospital
Finland
- - Helsinki, Finland, 00029 HUS
    - Recruiting
    - Helsinki University Hospital, Department of Pediatric Hematology and Oncology
  - Kuopio, Finland, 70029 KYS
    - Recruiting
    - Kuopio University Hospital, Department of Pediatric Hematology and Oncology
  - Oulu, Finland, 90029 OYS
    - Recruiting
    - University Hospital of Oulu, Paediatric Haematology and Oncology
  - Tampere, Finland, 33521 Tampere
    - Recruiting
    - Tampere University Hospital, Paediatric Haematology and Oncology
  - Turku, Finland, 20521 Turku
    - Recruiting
    - Turku University Hospital, Paediatric and Adolescent Haematology and Oncology
France
- - Amiens, France, 80054
    - Not yet recruiting
    - Service d'oncolologie, Hématologie pédiatrique. CHU Amiens, Avenue René Laënnec - SALOUEL
  - Angers, France, 49033
    - Not yet recruiting
    - Pôle Femme Mère Enfant ; Unité d'Hématologie/Oncologie pédiatrique, CHU Angers
  - Besançon, France, 25030
    - Not yet recruiting
    - Hématologie Oncologie pédiatrique, CHRU Besançon
  - Bordeaux, France, 33076
    - Not yet recruiting
    - Hôpital de Enfants, Unité Onco-Hématologie Pédiatrique, Groupe Hospitalier Pellegrin
  - Brest, France, 29609
    - Not yet recruiting
    - Département de Pédiatrie et Génétique Médicale CHRU Morvan
  - Caen, France, 14033
    - Not yet recruiting
    - Unité d'hémato-immuno-oncologie pédiatrique. Centre Hospitalier Universitaire niveau 1 - bâtiment FEH
  - Clermont-Ferrand, France, 63303
    - Not yet recruiting
    - Unité Onco- Hématologie Pédiatrique CHU Estaing 1 place Lucie-Aubrac
  - Dijon, France, 21079
    - Not yet recruiting
    - Service Immuno-Hématologie Oncologie Pédiatrique
  - Grenoble, France, 38043
    - Not yet recruiting
    - Service onco hématologie pédiatrique CHU de Grenoble site Nord - Hôpital Couple enfant
  - Lille, France, 59037
    - Not yet recruiting
    - Unité d'hématologie pédiatrique CHRU de Lille - Hôpital Jeanne de Flandre
  - Limoges, France, 87042
    - Not yet recruiting
    - Service d'Hématologie - Oncologie pédiatrique CHU Limoges - Hôpital de la mère et de l'enfant
  - Lyon, France, 69373
    - Not yet recruiting
    - Service d'immuno-hématologie pédiatrique et de transplantation de moelle osseuse, CHU de Lyon HCL - GH Est-Institut d'hématologie et d'oncologie pédiatrique IHOP
  - Marseille, France, 13385
    - Not yet recruiting
    - Service de Pédiatrie et hématologie pédiatrique, CHU de Marseille - Hôpital de la Timone
  - Montpellier, France, 34295
    - Not yet recruiting
    - UAM Hématologie et Oncologie Pédiatrique, CHU de Montpellier - Hôpital Arnaud de Villeneuve
  - Nantes, France, 44093
    - Not yet recruiting
    - Service d'hématologie et oncologie pédiatriques, Hôpital enfant-adolescent, CHU NANTES
  - Nice, France, 06200
    - Not yet recruiting
    - Service d'hémato-oncologie pédiatrique CHU NICE - Hôpital l'Archet 2
  - Paris, France, 75005
    - Not yet recruiting
    - service d'oncologie pédiatrique, institut Curie
  - Paris, France, 75012
    - Not yet recruiting
    - Service Hémato-immuno- oncologie- CHU PARIS Armand Trousseau
  - Paris, France, 75019
    - Not yet recruiting
    - Service d' hémato-immunologie CHU Paris - Hôpital Robert Debré
  - Poitiers, France, 86000
    - Not yet recruiting
    - Service Oncologie-Hématologie pédiatrique CHU de Poitiers
  - Reims, France, 51100
    - Not yet recruiting
    - Service d'Hémato-Oncologie Pédiatrique- American Hospital
  - Rennes, France, 35203
    - Not yet recruiting
    - Pôle pédiatrie Hémato-cancérologie pédiatrique- CHU RENNES - Hôpital sud
  - Rouen, France, 76031
    - Not yet recruiting
    - Service d'Hemato-Oncologie Pediatrique CHU Rouen
  - Saint-Denis, France, 97405
    - Not yet recruiting
    - service d'oncologie pédiatrique, hopital Félix Guyon
  - Saint-Priest-en-Jarez, France, 42270
    - Not yet recruiting
    - Pôle mère enfant-Unité Hématologie - Oncologie pédiatrique - CHU Hôpital NORD
  - Strasbourg, France, 67098
    - Not yet recruiting
    - Service d'Onco-Hematologie Pediatrique CHU STRASBOURG -Hôpital de Hautepierre
  - Toulouse, France, 31059
    - Not yet recruiting
    - Service Pédiatrie - Hématologie Immunologie Oncologie - CHU Toulouse
  - Vandœuvre-lès-Nancy, France, 54511
    - Not yet recruiting
    - Service d'hémato-oncologie pédiatrique- CHU de Nancy - Hôpital de Brabois Enfant
  - Villejuif, France, 94805
    - Not yet recruiting
    - Dépt de Pédiatrie Gustave Roussy
Germany
- - Aachen, Germany, 52057
    - Recruiting
    - Universitätsklinikum Aachen .Klinik für Kinder - und Jugendmedizin Hämatologie / Onkologie
  - Augsburg, Germany, 86156
    - Recruiting
    - Klinikum Augsburg ,Schwäbisches Kinderkrebszentrum. I. Klinik für Kinder und Jugendliche Hämatologie / Onkologie
  - Berlin, Germany, 13125
    - Recruiting
    - HELIOS Klinikum Berlin-Buch, Kinderklinik, Pädiatrische Hämatologie und Onkologie
  - Berlin, Germany, 13353
    - Recruiting
    - Charité Campus Virchow-Klinikum, Zentrum für Kinder- und Jugendmedizin- Abt. Hämatologie / Onkologie
  - Bielefeld, Germany, 33617
    - Recruiting
    - Evangelisches Krankenhaus Bielefeld GmbH, Klinik für Kinder- und Jugendmedizin, Hämatologie und Onkologie
  - Bonn, Germany, 55113
    - Recruiting
    - Zentrum für Kinderheilkunde der Universität Bonn, Abt. Päd. Hämatologie / Onkologie
  - Braunschweig, Germany, 38118
    - Recruiting
    - Städtisches Klinikum Braunschweig gGmbH, Klinik für Kinder- und Jugendmedizin, Station K5 / Päd. Hämato- und Onkologie
  - Bremen, Germany, 28177
    - Recruiting
    - Klinikum Bremen-Mitte gGmbH, Prof.-Hess-Kinderklinik,Pädiatrische Onkologie und Hämatologie
  - Chemnitz, Germany, 09116
    - Not yet recruiting
    - Klinikum Chemnitz gGmbH, Klinik für Kinder- und Jugendmedizin, Päd. Hämatologie und Onkologie
  - Cottbus, Germany, 03048
    - Recruiting
    - Carl-Thiem-Klinikum, Kinderklinik, Station 5e
  - Datteln, Germany, 45711
    - Recruiting
    - Vestische Kinderklinik, Universität Witten / Herdecke
  - Dortmund, Germany, 44137
    - Recruiting
    - Klinikum Dortmund gGmbH, Klinik für Kinder- und Jugendmedizin, Station K1, Abt. Päd. Onkologie / Hämatologie
  - Dresden, Germany, 01307
    - Recruiting
    - Universitätsklinik Carl Gustav Carus der TU Dresden, Klinik für Kinder- und Jugendmedizin
  - Düsseldorf, Germany, 40225
    - Recruiting
    - Universitätsklinikum Düsseldorf, Zentrum für Kinder- und Jugendmedizin, Klinik für Päd. Hämatologie und Onkologie
  - Erfurt, Germany, 99089
    - Recruiting
    - HELIOS Klinikum Erfurt GmbH, Klinik für Kinder- und Jugendmedizin, Päd. Onkologie / Hämatologie
  - Erlangen, Germany, 91054
    - Recruiting
    - Universitätsklinikum Erlangen, Klinik für Kinder- und Jugendmedizin, Pädiatrische Onkologie / Hämatologie
  - Essen, Germany, 45122
    - Recruiting
    - Universitätsklinikum Essen, Zentrum für Kinder- und Jugendmedizin, Hämatologie / Onkologie
  - Frankfurt, Germany, 60590
    - Recruiting
    - Universitätsklinikum Frankfurt, Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie und Onkologie
  - Freiburg, Germany, 79106
    - Recruiting
    - Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin, Klinik IV: Päd. Hämatologie und Onkologie
  - Gießen, Germany, 35385
    - Recruiting
    - Universitätsklinikum Gießen und Marburg, Standort Gießen, Zentrum für Kinderhämatologie und -onkologie
  - Greifswald, Germany, 17475
    - Recruiting
    - Universitätsklinikum Greifswald KdöR, Klinik und Poliklinik für Kinder- und Jugendmedizin, Abt. Pädiatrische Onkologie und Hämatologie
  - Göttingen, Germany, 37075
    - Recruiting
    - Georg-August-Universität Universitäts-Kinderklinik, Pädiatrie I
  - Halle, Germany, 06120
    - Recruiting
    - Universitätsklinikum Halle (Saale), Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie / Onkologie
  - Hamburg, Germany, 20246
    - Recruiting
    - Universitätsklinikum Hamburg Eppendorf, Zentrum für Kinder- und Jugendmedizin, Abt. Pädiatrische Hämatologie und Onkologie
  - Hannover, Germany, 30625
    - Not yet recruiting
    - Medizinische Hochschule Hannover, Kinderheilkunde, Päd. Hämatologie / Onkologie
  - Heidelberg, Germany, 69120
    - Recruiting
    - Universitäts-Kinderklinik Heidelberg, Abt. Hämatologie / Onkologie
  - Herdecke, Germany, 58313
    - Recruiting
    - Gemeinschaftskrankenhaus Herdecke, Kinder- und Jugendmedizin, Päd. Hämatologie / Onkologie
  - Homburg, Germany, 66421
    - Recruiting
    - Universitätskliniken für Kinder- und Jugendmedizin, Päd. Hämatologie und Onkologie, Geb. 9
  - Jena, Germany, 07745
    - Recruiting
    - Universitätsklinikum Jena, Klinik für Kinder- und Jugendmedizin
  - Karlsruhe, Germany, 76133
    - Recruiting
    - Städtisches Klinikum Karlsruhe gGmbH, Kinderklinik, Station S 24
  - Kassel, Germany, 34125
    - Recruiting
    - Klinikum Kassel Gesundheit Nordhessen Holding AG, Klinik für pädiatrische Hämatologie und Onkologie
  - Kiel, Germany, 24105
    - Recruiting
    - Universitätsklinikum Schleswig Holstein Campus Kiel, Klinik für Allgemeine Pädiatrie, Päd. Onkologie / Hämatologie
  - Koblenz, Germany, 56073
    - Recruiting
    - Gemeinschaftsklinikum Mittelrhein Kemperhof, Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie und Onkologie
  - Krefeld, Germany, 47805
    - Recruiting
    - HELIOS Klinikum Krefeld, Zentrum für Kinder- und Jugendmedizin, Päd. Hämatologie/Onkologie
  - Köln, Germany, 50924
    - Not yet recruiting
    - Klinikum der Universität zu Köln, Klinik für Kinder- und Jugendmedizin, Abt. Kinderonkologie und -hämatologie
  - Leipzig, Germany, 04103
    - Recruiting
    - Universitätsklinikum Leipzig, Klinik für Kinder und Jugendliche, Abt. Päd. Hämatologie / Onkologie
  - Lübeck, Germany, 23538
    - Recruiting
    - Universitätsklinikum Schleswig Holstein Campus Lübeck, Klinik für Kinder- und Jugendmedizin, Hämatologie und Onkologie
  - Magdeburg, Germany, 39120
    - Recruiting
    - Universitätsklinikum Magdeburg A. ö. R., Kinderklinik, Päd. Hämatologie / Onkologie
  - Mainz, Germany, 55101
    - Recruiting
    - Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Zentrum für Kinder- und Jugendmedizin, Pädiatrische Hämatologie / Onkologie
  - Manheim, Germany, 68167
    - Recruiting
    - Klinikum Mannheim gGmbH, Universitäts-Kinderklinik, Päd. Onkologie /Hämatologie
  - Minden, Germany, 32429
    - Recruiting
    - Johannes Wesling Klinikum Minden, Klinik für Kinder- und Jugendmedizin, Päd. Hämatologie / Onkologie, Station E 22
  - München, Germany, 80804
    - Recruiting
    - Klinikum Schwabing, Kinderklinik der TU Päd. Hämatologie / Onkologie, Station 24d
  - München, Germany, 80337
    - Not yet recruiting
    - Klinikum der LMU, Dr. von Haunersches Kinderspital, Pädiatrische Hämatologie / Onkologie
  - Münster, Germany, 48149
    - Recruiting
    - Universitätsklinikum Münster, Klinik für Kinder- und Jugendmedizin, Abt. Pädiatrische Hämatologie und Onkologie
  - Nürnberg, Germany, 90419
    - Recruiting
    - Diakonie Neuendettelsau, Kliniken Hallerwiese / Cnopf'sche Kinderklinik, Pädiatrische Hämatologie /Onkologie
  - Oldenburg, Germany, 26133
    - Recruiting
    - Klinikum Oldenburg AöR, Zentrum für Kinder- und Jugendmedizin, Abt. Hämatologie / Onkologie
  - Regensburg, Germany, 93053
    - Recruiting
    - Universitätsklinikum Regensburg, Klinik für Kinder- und Jugendmedizin, Abt. Päd. Hämatologie, Onkologie, SZT
  - Rostock, Germany, 18057
    - Recruiting
    - Universitätsklinikum Rostock, Kinder- und Jugendklinik, Päd. Hämatologie und Onkologie
  - Sankt Augustin, Germany, 53757
    - Recruiting
    - Asklepios Klinik St. Augustin GmbH, Kinder- und Jugendmedizin, Kinder-Hämatologie und Onkologie
  - Schwerin, Germany, 19049
    - Recruiting
    - HELIOS Kliniken Schwerin GmbH, Klinik für Kinder- und Jugendmedizin, Station A1
  - Stuttgart, Germany, 70174
    - Recruiting
    - Klinikum Stuttgart, Olgahospital Zentrum für Kinder- und Jugendmedizin Pädiatrie 5 (Onkologie, Hämatologie, Immunologie)
  - Trier, Germany, 54290
    - Withdrawn
    - Klinikum Mutterhaus der Borromäerinnen gGmbH, Pädiatrische Abteilung
  - Tübingen, Germany, 72076
    - Recruiting
    - Universitätsklinik Tübingen, Klinik für Kinderheilkunde und Jugendmedizin, Päd. Hämatologie / Onkologie
  - Ulm, Germany, 89081
    - Recruiting
    - Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin, Päd. Hämatologie und Onkologie
  - Würzburg, Germany, 97080
    - Recruiting
    - Universitätskinderklinik Würzburg, Päd. Onkologie und Hämatologie
Hungary
- - Budapest, Hungary
    - Not yet recruiting
    - 2nd Dep. of Pediatrics, Semmelweis Univ
  - Budapest, Hungary
    - Not yet recruiting
    - Heim Pal Children Hospital
  - Debrecen, Hungary
    - Not yet recruiting
    - Dep. of Pediatrics, Univ. of Debrecen
  - Miskolc, Hungary
    - Not yet recruiting
    - Children's Treating Center, Miskolc
  - Pécs, Hungary
    - Not yet recruiting
    - Dep. of Pediatrics, University of Pecs
  - Szeged, Hungary
    - Not yet recruiting
    - Dep. of Pediatrics, Univ. of Szeged
Ireland
- - Dublin, Ireland
    - Not yet recruiting
    - Our Lady's Children's Hospital Crumlin
Israel
- - Be'er Sheva, Israel
    - Not yet recruiting
    - Children's Hospital at Soroka Medical Center
  - Haifa, Israel
    - Not yet recruiting
    - Ruth Rappaport Children's Hospital, Rambam Medical Center
  - Jerusalem, Israel
    - Not yet recruiting
    - Children's Hospital at Hadassah, Ein Kerem Medical Center
  - Petah tikva, Israel
    - Not yet recruiting
    - Schneider Children's hospital, Rabin Medical Center
  - Ramat Gan, Israel
    - Not yet recruiting
    - Edmond and Lily Safra Children's Hospital, Sheba Medical Center
  - Tel Aviv, Israel
    - Not yet recruiting
    - Dana Children's Hospital, Tel-Aviv Sourasky Medical Center
Italy
- - Ancona, Italy, 60123
    - Not yet recruiting
    - Clinica Pediatrica, Centro Regionale Oncoematologia Pediatrica- Ospedale dei Bambini "G. Salesi"
  - Bari, Italy, 70124
    - Not yet recruiting
    - Dipartimento Biomedicina Età Evolutiva- U.O. Pediatrica I Policlinico
  - Bergamo, Italy, 24100
    - Not yet recruiting
    - Dipartimento Pediatrico degli OO.RR. di Bergamo
  - Bologna, Italy, 40138
    - Not yet recruiting
    - Dipartimento di Scienze Pediatriche Mediche Chirurgiche Ospedale Sant'Orsola Malpighi
  - Brescia, Italy, 25123
    - Not yet recruiting
    - Clinica Pediatrica Ospedale Civile
  - Cagliari, Italy, 09121
    - Not yet recruiting
    - Istituto di Clinica Pediatrica- Ospedale Regionale Microcitemie
  - Catania, Italy, 95123
    - Not yet recruiting
    - Divisione Ematologia - Oncologia Pediatrica, Clinica Pediatrica
  - Cosenza, Italy, 87100
    - Not yet recruiting
    - U. O. di Pediatria- Azienda Ospedaliera Annunziata
  - Ferrara, Italy, 44100
    - Not yet recruiting
    - Dipartimento di Medicina Clinica e Sperimentale Sezione di Pediatria - Università di Ferrara
  - Firenze, Italy, 50132
    - Not yet recruiting
    - Unità Autonoma di Oncoematologia Pediatrica, Dipartimento Pediatria - Azienda "A.Meyer"
  - Genova, Italy, 16148
    - Not yet recruiting
    - Dipartimento di Ematologia e Oncologia Pediatrica Istituto " G. Gaslini"
  - Milano, Italy, 20133
    - Not yet recruiting
    - Divisione di Oncologia Pediatrica Ist. Nazionale Studio e Cura Tumori
  - Modena, Italy, 41100
    - Not yet recruiting
    - U.O. di Ematologia, Oncologia e Trapianto-Azienda Policlinico di Modena
  - Monza, Italy, 20052
    - Not yet recruiting
    - Clinica Pediatrica Ospedale S. Gerardo Via Donizetti
  - Napoli, Italy, 80123
    - Not yet recruiting
    - S.C. Ematologia Oncologica- Ospedale "Pausilipon"
  - Padova, Italy, 35128
    - Not yet recruiting
    - Clinica di Oncoematologia Pediatrica- Azienda Ospedaliera-Università di Padova
  - Palermo, Italy, 90100
    - Not yet recruiting
    - Oncoematologia Pediatrica- Ospedale dei Bambini G. di Cristina
  - Parma, Italy, 43100
    - Not yet recruiting
    - U.O. di Pediatria e Oncoematologia Pediatrica. Az. Osp. di Parma
  - Pavia, Italy, 27100
    - Not yet recruiting
    - Oncoematologia Pediatrica IRCCS, Policlinico San Matteo Piazzale Golgi
  - Pescara, Italy, 65123
    - Not yet recruiting
    - Dipartimento di Ematologia -Ospedale Civile
  - Rimini, Italy, 47900
    - Not yet recruiting
    - U.O. Pediatria Ospedale Infermi- Azienda USL Rimini
  - Roma, Italy, 00161
    - Not yet recruiting
    - Sezione Ematologia- Dipart. Biotecnico Cellulare ed Ematologia- Università "La Sapienza"
  - Roma, Italy, 00165
    - Not yet recruiting
    - Divisione di Ematologia Pediatrica- Ospedale "Bambino Gesù". Istituto di Ricerca Scientifica
  - San Giovanni Rotondo, Italy, 71013
    - Not yet recruiting
    - Divisione di Pediatria- Ospedale "Casa Sollievo della Sofferenza"
  - San Sisto, Italy, 06080
    - Not yet recruiting
    - Oncologia Pediatrica,- Ospedale "R. Silvestrini"
  - Torino, Italy, 10126
    - Not yet recruiting
    - Dip. Scienze Pediatriche e dell'Adolescenza Ospedale Infantile Regina Margherita
  - Trieste, Italy, 34137
    - Not yet recruiting
    - U.O. Emato-Oncologia Pediatrica- Università degli studi di Trieste-Ospedale Infantile Burlo Garofolo
  - Verona, Italy, 37134
    - Not yet recruiting
    - U.O. Oncoematologia Pediatrica- Policlinico "G.B. Rossi"
Netherlands
- - Utrecht, Netherlands, 3584CS
    - Not yet recruiting
    - Princess Maxima Centre for Pediatric Oncology
Norway
- - Bergen, Norway
    - Recruiting
    - Haukeland University Hospital in Bergen
  - Tromsø, Norway
    - Recruiting
    - University Hospital Northern Norway
  - Trondheim, Norway
    - Recruiting
    - St Olavs Hospital in Trondheim
Poland
- - Białystok, Poland, 15-247
    - Not yet recruiting
    - Department of Pediatric Oncology and Hematology, Medical University of Bialystok
  - Bydgoszcz, Poland, 85-094
    - Not yet recruiting
    - Department of Pediatric Hematology and Oncology, Nicolaus Copernicus University
  - Chorzów, Poland, 41-500
    - Not yet recruiting
    - Department of Pediatric Hematology and Oncology, Center of Pediatrics and Oncology in Chorzów
  - Gdańsk, Poland, 20-211
    - Not yet recruiting
    - Department of Pediatrics, Hematology, Oncology and Endocrinology, Medical University of Gdansk
  - Kielce, Poland, 25-736
    - Not yet recruiting
    - Department of Pediatric Oncology and Hematology, Center of Pediatrics in Kielce
  - Kraków, Poland, 30-663
    - Not yet recruiting
    - Department of Pediatric Oncology/Hematology, Institute of Pediatrics, Medical College Jagiellonian University
  - Lublin, Poland, 20-093
    - Not yet recruiting
    - Department of Pediatric Hematology, Oncology and Transplantology, Medical University of Lublin
  - Olsztyn, Poland, 10-561
    - Not yet recruiting
    - Department of Pediatric Oncology and Hematology, Provincial Specialist Children's Hospital
  - Poznań, Poland, 60-572
    - Not yet recruiting
    - Department of Pediatric Oncology, Hematology and Transplantology, Poznan University of Medical Sciences
  - Rzeszów, Poland, 35-301
    - Not yet recruiting
    - Department of Paediatric Oncology and Haematology, University of Rzeszów, Department of Pediatrics
  - Szczecin, Poland, 71-242
    - Not yet recruiting
    - Department of Pediatrics, Children Hematology nad Oncology, Pomeranian Medical University
  - Warsaw, Poland, 00-576
    - Not yet recruiting
    - Department of Pediatrics, Hematology and Oncology, Medical University of Warsaw
  - Warsaw, Poland, 04-576
    - Not yet recruiting
    - Department of Pediatric Oncology, Children's Memorial Health Institute
  - Wrocław, Poland, 50-556
    - Not yet recruiting
    - Department of Bone Marrow Transplantation, Children Oncology and Hematology, Wroclaw Medical University
  - Zabrze, Poland, 41-800
    - Not yet recruiting
    - Department of Pediatric Hematology and Oncology, Silesian Medical University in Katowice
  - Łódź, Poland, 91-138
    - Not yet recruiting
    - Department of Pediatrics, Oncology, Hematology and Diabetology, Institute of Pediatrics, Medical University of Lodz
Portugal
- - Coimbra, Portugal, 3000-602
    - Not yet recruiting
    - Centro Hospitalar e Universitário de Coimbra
  - Lisboa, Portugal, 1099-023
    - Not yet recruiting
    - Instituto Português de Oncologia - Francisco Gentil - Libosa
  - Porto, Portugal, 4200-072
    - Not yet recruiting
    - Instituto Português de Oncologia - Francisco Gentil - Porto
Russian Federation
- - Ekaterinburg, Russian Federation
    - Recruiting
    - Oncological center of regional Children's Hospital
  - Moscow, Russian Federation, 117198
    - Recruiting
    - National Center for Pediatric Hematology, Oncology and Immunology Moscow
Slovakia
- - Banská Bystrica, Slovakia, 974 09
    - Not yet recruiting
    - Department of pediatric oncology and hematology, Children´s Faculty Hospital
  - Bratislava, Slovakia, 833 40
    - Not yet recruiting
    - Department of pediatric hematology and oncology, National Institute of Children's Diseases
  - Košice, Slovakia, 04011
    - Not yet recruiting
    - Department of pediatric hematology and oncology, Children´s University Hospital
Spain
- - Alicante, Spain, 03010
    - Recruiting
    - Hospital General Universitario de Alicante
  - Almería, Spain, 04009
    - Recruiting
    - Hospital Universitario Torrecárdenas
  - Badajoz, Spain, 06010
    - Recruiting
    - Hospital Materno-Infantil de Badajoz
  - Baracaldo, Spain, 48903
    - Recruiting
    - Hospital Universitario Cruces
  - Barcelona, Spain, 08035
    - Recruiting
    - Hospital Universitari Vall d'Hebron
  - Barcelona, Spain, 08041
    - Recruiting
    - Hospital de La Santa Creu i Sant Pau
  - Donostia, Spain, 20014
    - Recruiting
    - Hospital Universitario Donostia
  - Esplugues De Llobregat, Spain, 08950
    - Recruiting
    - Hospital Sant Joan de Déu
  - Granada, Spain, 18014
    - Recruiting
    - Hospital Universitario Virgen de las Nieves
  - Las Palmas De Gran Canaria, Spain, 35016
    - Recruiting
    - Complejo Hospitalario Universitario Insular Materno Infantil
  - Madrid, Spain, 28041
    - Recruiting
    - Hospital Universitario 12 de Octubre
  - Madrid, Spain, 28046
    - Recruiting
    - Hospital Universitario La Paz
  - Madrid, Spain, 28007
    - Recruiting
    - Hospital General Universitario Gregorio Marañon
  - Madrid, Spain, 28009
    - Recruiting
    - Hospital Infantil Universitario Nino Jesus
  - Murcia, Spain, 30120
    - Recruiting
    - Hospital Clínico Universitario Virgen de la Arrixaca
  - Málaga, Spain, 29010
    - Recruiting
    - Hospital Regional Universitario de Malaga
  - Oviedo, Spain, 33011
    - Recruiting
    - Hospital Universitario Central de Asturias
  - Palma De Mallorca, Spain, 07120
    - Recruiting
    - Hospital Universitari Son Espases
  - Pamplona, Spain, 31008
    - Recruiting
    - Hospital Virgen del Camino
  - Pontevedra, Spain, 36036
    - Recruiting
    - Complejo Hospitalario Universitario de Vigo
  - Santa Cruz De Tenerife, Spain, 38010
    - Recruiting
    - Hospital Universitario Nuestra Señora de Candelaria
  - Santander, Spain, 390008
    - Recruiting
    - Hospital Universitario Marqués de Valdecilla
  - Santiago De Compostela, Spain, 15706
    - Recruiting
    - Hospital Clinico Universitario de Santiago
  - Sevilla, Spain, 41009
    - Recruiting
    - Hospital Universitario Virgen Macarena
  - Sevilla, Spain, 41013
    - Recruiting
    - Hospital Universitario Virgen del Rocio
  - Toledo, Spain, 45004
    - Recruiting
    - Hospital Virgen De La Salud
  - Valencia, Spain, 46010
    - Recruiting
    - Hospital Clinico Universitario de Valencia
  - Valencia, Spain, 46026
    - Recruiting
    - Hospital Universitari i Politecnic La Fe
  - Valladolid, Spain, 47003
    - Recruiting
    - Hospital Clínico Universitario de Valladolid
  - Zaragoza, Spain, 50009
    - Recruiting
    - Hospital Universitario Miguel Servet
Sweden
- - Göteborg, Sweden, 416 85
    - Recruiting
    - Barncancercentrum, Drottning Silvias Barn och Ungdomssjukhus, Sahlgrenska Universitetssjukhuset
  - Linköping, Sweden, 581 85
    - Recruiting
    - Barnonkologiska enheten, Barn och Ungdomsmedicinska kliniken, Universitetssjukhuset i Linköping
  - Lund, Sweden, 221 85
    - Recruiting
    - Barnonkologi, Skåne Universitetssjukhus
  - Stockholm, Sweden, 171 76
    - Recruiting
    - Barncanceravdelningen Astrid Lindgrens Barnsjukhus, Nya Karolinska Universitetssjukhuset
  - Umeå, Sweden, 901 85
    - Recruiting
    - Barnonkologiska avdelningen, Barn 3, Norrlands Universitetssjukhus
  - Uppsala, Sweden, 752 39
    - Recruiting
    - Barnavdelningen för blod- och tumörsjukdomar 95A, Akademiska sjukhuset
Switzerland
- - Aarau, Switzerland, 5001
    - Not yet recruiting
    - Kantonsspital Aarau
  - Basel, Switzerland, 4056
    - Not yet recruiting
    - Universitäts-Kinderspital beider Basel (UKBB)
  - Bellinzona, Switzerland, 6500
    - Not yet recruiting
    - Ospedale San Giovanni
  - Bern, Switzerland, 3010
    - Not yet recruiting
    - Inselspital Bern, University of Bern
  - Geneva, Switzerland, 1211
    - Not yet recruiting
    - HUG Hôpitaux Universitaires de Gèneve
  - Lausanne, Switzerland, 1011
    - Not yet recruiting
    - CHUV - Centre hospitalier universitaire vaudois
  - Luzern, Switzerland, 6000
    - Not yet recruiting
    - Luzerner Kantonspital - Kinderspital Luzern
  - Sankt Gallen, Switzerland, 9006
    - Not yet recruiting
    - Ostschweizer Kinderspital
  - Zürich, Switzerland, 8032
    - Not yet recruiting
    - Universitäts-Kinderspital Zürich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 16 years (Child, Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion criteria:

newly diagnosed lymphoblastic lymphoma
age <18 years
patient enrolled in a participating center
written informed consent of patient (>14 years of age or according to local law and regulation) and parents to trial participation and transfer and processing of data
willingness of patients and the investigator/pathologist to provide adequate slides/blocks for reference (molecular) pathology and international pathology panel and/or fresh or fresh frozen samples for genetic risk group stratification if these samples are available after standard diagnostic procedures.

Exclusion criteria:

lymphoblastic lymphoma as secondary malignancy
non-lymphoma related relevant medical, psychiatric or social conditions incompatible with trial treatment, including among others
- prior organ transplant
- severe immunodeficiency
- demyelinating Charcot-Marie Tooth syndrome
- serious acute or chronic infections, such as HIV, VZV and tuberculosis
- urinary tract infection, cystitis, urinary outflow obstruction, severe renal impairment (creatinine clearance less than 20 ml/min)
- severe hepatic impairment (bilirubin >3 times ULN, transaminases >10 times ULN)
- myocardial insufficiency, severe arrhythmias
- ulcers of the oral cavity and known active gastrointestinal ulcer disease
- known hypersensitivity to any IMP and to any excipient (listed in section 6.1 of the respective SmPC)
steroid pre-treatment with ≥ 1 mg/kg/d for more than two weeks during the last month before diagnosis
vaccination with live vaccines within 2 weeks before start of protocol treatment
treatment started according to another protocol or pre-treatment with cytostatic drugs
participation in another clinical trial that interferes with the protocol, except NHL-BFM Registry 2012 and trials with different endpoints, involving aspects of supportive treatment, which can run parallel to LBL 2018 without influencing the outcome of this trial (e.g. trials on antiemetics, antibiotics, strategies for psychosocial support)
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 cytostatic therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: SR I/II: R1 into protocol Ia-Pred cytoreductive prephase with prednisone standard induction phase (protocol Ia-prednisone) consolidation phase (protocol Ib) non-HR extra-compartment phase (protocol M) maintenance therapy	Drug: Cyclophosphamide Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: Cytarabine No involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2). Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: Daunorubicin Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: 6-Mercaptopurine Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: Methotrexate Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: PEG asparaginase Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Protocol Ib* (Randomization R2) Drug: Prednisone Part of standard chemotherapy Drug: Prednisolone No involvement of CNS: Part of standard chemotherapy. Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2 Drug: Vincristine Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
Experimental: SR I/II: R1 into protocol Ia-Dexa cytoreductive prephase with prednisone experimental induction phase (protocol Ia-dexamethasone) consolidation phase (protocol Ib) non-HR extra-compartment Phase (protocol M) maintenance therapy	Drug: Cyclophosphamide Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: Cytarabine No involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2). Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: Daunorubicin Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: 6-Mercaptopurine Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: Methotrexate Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: PEG asparaginase Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Protocol Ib* (Randomization R2) Drug: Prednisone Part of standard chemotherapy Drug: Prednisolone No involvement of CNS: Part of standard chemotherapy. Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2 Drug: Vincristine Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: Dexamethasone Part of the experimental therapy in Randomization R1 (Protocol Ia-Dexamethasone) and in Randomization R2 (Intensified Protocol M)
Other: SR: R1 into protocol Ia-Pred cytoreductive prephase with prednisone standard induction phase (protocol Ia-prednisone) consolidation phase (protocol Ib) non-HR extra-compartment phase (protocol M) reintensification phase (protocol II) maintenance therapy	Drug: Doxorubicin Part of standard chemotherapy Drug: Cyclophosphamide Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: Cytarabine No involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2). Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: Daunorubicin Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: 6-Mercaptopurine Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: Methotrexate Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: PEG asparaginase Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Protocol Ib* (Randomization R2) Drug: Prednisone Part of standard chemotherapy Drug: Prednisolone No involvement of CNS: Part of standard chemotherapy. Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2 Drug: Vincristine Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: Dexamethasone Part of the experimental therapy in Randomization R1 (Protocol Ia-Dexamethasone) and in Randomization R2 (Intensified Protocol M) Drug: Thioguanine Part of standard chemotherapy
Experimental: SR: R1 into protocol Ia-Dexa cytoreductive prephase with prednisone experimental induction phase (protocol Ia-dexamethasone) consolidation phase (protocol Ib) non-HR extra-compartment phase (protocol M) reintensification phase (protocol II) maintenance therapy	Drug: Doxorubicin Part of standard chemotherapy Drug: Cyclophosphamide Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: Cytarabine No involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2). Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: Daunorubicin Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: 6-Mercaptopurine Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: Methotrexate Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: PEG asparaginase Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Protocol Ib* (Randomization R2) Drug: Prednisone Part of standard chemotherapy Drug: Prednisolone No involvement of CNS: Part of standard chemotherapy. Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2 Drug: Vincristine Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: Dexamethasone Part of the experimental therapy in Randomization R1 (Protocol Ia-Dexamethasone) and in Randomization R2 (Intensified Protocol M) Drug: Thioguanine Part of standard chemotherapy
Other: HR: R1 into "Pred" and R2 into non-HR extra-compartment phase cytoreductive prephase with prednisone standard induction phase (protocol Ia-prednisone) consolidation phase (protocol Ib) non-HR extra-compartment phase (protocol M) reintensification phase (protocol II) maintenance therapy	Drug: Doxorubicin Part of standard chemotherapy Drug: Cyclophosphamide Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: Cytarabine No involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2). Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: Daunorubicin Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: 6-Mercaptopurine Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: Methotrexate Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: PEG asparaginase Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Protocol Ib* (Randomization R2) Drug: Prednisone Part of standard chemotherapy Drug: Prednisolone No involvement of CNS: Part of standard chemotherapy. Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2 Drug: Vincristine Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: Dexamethasone Part of the experimental therapy in Randomization R1 (Protocol Ia-Dexamethasone) and in Randomization R2 (Intensified Protocol M) Drug: Thioguanine Part of standard chemotherapy
Experimental: HR: R1 into "Dexa" and R2 into non-HR extra-compartment phase cytoreductive prephase with prednisone experimental induction phase (protocol Ia-dexamethasone) consolidation phase (protocol Ib) non-HR extra-compartment phase (protocol M) reintensification phase (protocol II) maintenance therapy	Drug: Doxorubicin Part of standard chemotherapy Drug: Cyclophosphamide Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: Cytarabine No involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2). Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: Daunorubicin Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: 6-Mercaptopurine Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: Methotrexate Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: PEG asparaginase Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Protocol Ib* (Randomization R2) Drug: Prednisone Part of standard chemotherapy Drug: Prednisolone No involvement of CNS: Part of standard chemotherapy. Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2 Drug: Vincristine Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: Dexamethasone Part of the experimental therapy in Randomization R1 (Protocol Ia-Dexamethasone) and in Randomization R2 (Intensified Protocol M) Drug: Thioguanine Part of standard chemotherapy
Experimental: HR: R1 into "Pred" and R2 into HR extra-compartment phase cytoreductive prephase with prednisone standard induction phase (protocol Ia-prednisone) consolidation phase (protocol Ib*) HR extra-compartment phase (intensified protocol M) reintensification phase (protocol II) maintenance therapy	Drug: Doxorubicin Part of standard chemotherapy Drug: Cyclophosphamide Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: Cytarabine No involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2). Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: Daunorubicin Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: 6-Mercaptopurine Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: Methotrexate Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: PEG asparaginase Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Protocol Ib* (Randomization R2) Drug: Prednisone Part of standard chemotherapy Drug: Prednisolone No involvement of CNS: Part of standard chemotherapy. Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2 Drug: Vincristine Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: Dexamethasone Part of the experimental therapy in Randomization R1 (Protocol Ia-Dexamethasone) and in Randomization R2 (Intensified Protocol M) Drug: Thioguanine Part of standard chemotherapy Drug: Ifosfamide Part of the experimental therapy in Randomization R2 (Intensified Protocol M) Drug: Vindesine Part of the experimental therapy in Randomization R2 (Intensified Protocol M)
Experimental: HR: R1 into "Dexa" and R2 into HR extra-compartment phase cytoreductive prephase with prednisone experimental induction phase (protocol Ia-dexamethasone) consolidation phase (protocol Ib*) HR extra-compartment phase (intensified protocol M) reintensification phase (protocol II) maintenance therapy	Drug: Doxorubicin Part of standard chemotherapy Drug: Cyclophosphamide Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: Cytarabine No involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2). Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: Daunorubicin Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: 6-Mercaptopurine Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: Methotrexate Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: PEG asparaginase Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Protocol Ib* (Randomization R2) Drug: Prednisone Part of standard chemotherapy Drug: Prednisolone No involvement of CNS: Part of standard chemotherapy. Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2 Drug: Vincristine Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Intensified Protocol M (Randomization R2) Drug: Dexamethasone Part of the experimental therapy in Randomization R1 (Protocol Ia-Dexamethasone) and in Randomization R2 (Intensified Protocol M) Drug: Thioguanine Part of standard chemotherapy Drug: Ifosfamide Part of the experimental therapy in Randomization R2 (Intensified Protocol M) Drug: Vindesine Part of the experimental therapy in Randomization R2 (Intensified Protocol M)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative incidence of relapse with involvement of the CNS (CNS-relapse, pCICR) Time Frame: through study completion, maximal 7.25 years	The time to relapse is defined as the time from randomization to the first relapse or the date of last follow-up. Other events (non-response, progressive disease, relapse, second malignancy or death before and in CR) will be taken into account as competing events.	through study completion, maximal 7.25 years
Estimated probability of event-free survival (pEFS) Time Frame: through study completion, maximal 7.25 years	The pEFS is defined as the time from randomization to the first event (non-response, progressive disease, relapse, second malignancy or death from any cause) or date of last follow-up.	through study completion, maximal 7.25 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival (pOS) Time Frame: through study completion, maximal 7.25 years	Survival (pOS) is defined as time from diagnosis to death due to any cause or to the date of last contact for patients alive	through study completion, maximal 7.25 years
Frequency of treatment-related toxicity overall and in specific protocol elements, randomized arms and during follow up Time Frame: through study completion, maximal 7.25 years		through study completion, maximal 7.25 years
Frequency of treatment-related mortality overall and in specific protocol elements, randomized arms and during follow up Time Frame: through study completion, maximal 7.25 years		through study completion, maximal 7.25 years
Frequency of adverse events of interest and severe adverse events overall Time Frame: through study completion, maximal 7.25 years		through study completion, maximal 7.25 years
Rate of evaluable patients for risk group stratification Time Frame: during recruitment		during recruitment
Cumulative incidence of relapses in association with molecular markers Time Frame: through study completion, maximal 7.25 years		through study completion, maximal 7.25 years
Cumulative incidence of relapses in association with minimal residual disease results Time Frame: through study completion, maximal 7.25 years		through study completion, maximal 7.25 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Muenster

Collaborators

Deutsche Krebshilfe e.V., Bonn (Germany)

Investigators

Principal Investigator: Birgit Burkhardt, Prof. Dr. Dr., University Hospital Muenster, Klinik für Kinder- und Jugendmedizin - Pädiatrische Hämatologie und Onkologie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Khanam T, Sandmann S, Seggewiss J, Ruether C, Zimmermann M, Norvil AB, Bartenhagen C, Randau G, Mueller S, Herbrueggen H, Hoffmann P, Herms S, Wei L, Woeste M, Wuensch C, Gowher H, Oschlies I, Klapper W, Woessmann W, Dugas M, Burkhardt B. Integrative genomic analysis of pediatric T-cell lymphoblastic lymphoma reveals candidates of clinical significance. Blood. 2021 Apr 29;137(17):2347-2359. doi: 10.1182/blood.2020005381.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2019

Primary Completion (Anticipated)

October 31, 2027

Study Completion (Anticipated)

October 31, 2027

Study Registration Dates

First Submitted

July 15, 2019

First Submitted That Met QC Criteria

July 31, 2019

First Posted (Actual)

August 2, 2019

Study Record Updates

Last Update Posted (Actual)

June 8, 2021

Last Update Submitted That Met QC Criteria

June 7, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

UKM17_0023
2017-001691-39 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

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Intervention / Treatment

Detailed Description

Study Type

Enrollment (Anticipated)

Phase

Contacts and Locations

Study Contact

Study Locations

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Ages Eligible for Study

Accepts Healthy Volunteers

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Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Anticipated)

Study Completion (Anticipated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Lymphoblastic Lymphoma, Childhood

Clinical Trials on Doxorubicin

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