International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma

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

Sponsors

Lead Sponsor: University Hospital Muenster

Collaborator: Deutsche Krebshilfe e.V., Bonn (Germany)

Source University Hospital Muenster
Brief Summary

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)

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.

Overall Status Recruiting
Start Date 2019-08-23
Completion Date 2027-10-31
Primary Completion Date 2027-10-31
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Cumulative incidence of relapse with involvement of the CNS (CNS-relapse, pCICR) through study completion, maximal 7.25 years
Estimated probability of event-free survival (pEFS) through study completion, maximal 7.25 years
Secondary Outcome
Measure Time Frame
Survival (pOS) through study completion, maximal 7.25 years
Frequency of treatment-related toxicity overall and in specific protocol elements, randomized arms and during follow up through study completion, maximal 7.25 years
Frequency of treatment-related mortality overall and in specific protocol elements, randomized arms and during follow up through study completion, maximal 7.25 years
Frequency of adverse events of interest and severe adverse events overall through study completion, maximal 7.25 years
Rate of evaluable patients for risk group stratification during recruitment
Cumulative incidence of relapses in association with molecular markers through study completion, maximal 7.25 years
Cumulative incidence of relapses in association with minimal residual disease results through study completion, maximal 7.25 years
Enrollment 683
Condition
Intervention

Intervention Type: Drug

Intervention Name: Cyclophosphamide

Description: 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)

Intervention Type: Drug

Intervention Name: Cytarabine

Description: 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)

Intervention Type: Drug

Intervention Name: Dexamethasone

Description: Part of the experimental therapy in Randomization R1 (Protocol Ia-Dexamethasone) and in Randomization R2 (Intensified Protocol M)

Intervention Type: Drug

Intervention Name: Daunorubicin

Description: 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)

Intervention Type: Drug

Intervention Name: Doxorubicin

Description: Part of standard chemotherapy

Intervention Type: Drug

Intervention Name: Ifosfamide

Description: Part of the experimental therapy in Randomization R2 (Intensified Protocol M)

Intervention Type: Drug

Intervention Name: 6-Mercaptopurine

Description: 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)

Intervention Type: Drug

Intervention Name: Methotrexate

Description: 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)

Intervention Type: Drug

Intervention Name: PEG asparaginase

Description: 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)

Intervention Type: Drug

Intervention Name: Prednisone

Description: Part of standard chemotherapy

Intervention Type: Drug

Intervention Name: Prednisolone

Description: 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

Intervention Type: Drug

Intervention Name: Thioguanine

Description: Part of standard chemotherapy

Intervention Type: Drug

Intervention Name: Vincristine

Description: 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)

Intervention Type: Drug

Intervention Name: Vindesine

Description: Part of the experimental therapy in Randomization R2 (Intensified Protocol M)

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

N/A

Maximum Age:

18 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Birgit Burkhardt, Prof. Dr. Dr. Principal Investigator University Hospital Muenster, Klinik für Kinder- und Jugendmedizin - Pädiatrische Hämatologie und Onkologie
Overall Contact

Last Name: Birgit Burkhardt, Prof. Dr. Dr.

Phone: +49 251 83 55696

Email: [email protected]

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

Austria

Belgium

China

Czechia

Denmark

Finland

France

Germany

Hungary

Ireland

Israel

Italy

Netherlands

Norway

Poland

Portugal

Russian Federation

Slovakia

Spain

Sweden

Switzerland

Verification Date

2021-06-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 8
Arm Group

Label: SR I/II: R1 into protocol Ia-Pred

Type: Other

Description: cytoreductive prephase with prednisone standard induction phase (protocol Ia-prednisone) consolidation phase (protocol Ib) non-HR extra-compartment phase (protocol M) maintenance therapy

Label: SR I/II: R1 into protocol Ia-Dexa

Type: Experimental

Description: cytoreductive prephase with prednisone experimental induction phase (protocol Ia-dexamethasone) consolidation phase (protocol Ib) non-HR extra-compartment Phase (protocol M) maintenance therapy

Label: SR: R1 into protocol Ia-Pred

Type: Other

Description: 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

Label: SR: R1 into protocol Ia-Dexa

Type: Experimental

Description: 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

Label: HR: R1 into "Pred" and R2 into non-HR extra-compartment phase

Type: Other

Description: 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

Label: HR: R1 into "Dexa" and R2 into non-HR extra-compartment phase

Type: Experimental

Description: 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

Label: HR: R1 into "Pred" and R2 into HR extra-compartment phase

Type: Experimental

Description: 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

Label: HR: R1 into "Dexa" and R2 into HR extra-compartment phase

Type: Experimental

Description: 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

Acronym LBL 2018
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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