Back to resultsInternational Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma (LBL 2018)
Primary Purpose
Lymphoblastic Lymphoma, Childhood
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cyclophosphamide
Cytarabine
Dexamethasone
Daunorubicin
Doxorubicin
Ifosfamide
6-Mercaptopurine
Methotrexate
PEG asparaginase
Prednisone
Prednisolone
Thioguanine
Vincristine
Vindesine
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoblastic Lymphoma, Childhood
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
Sites / Locations
- Univ.Klinik für Kinder- und Jugendheilkunde Graz, Klin. Abteilung für pädiatrische Hämato-OnkologieRecruiting
- Univ.Klinik für Kinder- und Jugendheilkunde Innsbruck, Universitätsklinik für Pädiatrie IRecruiting
- Kepler Universitätsklinikum, Med Campus IV / OnkologieRecruiting
- LKH Salzburg, Universitätsklinik für Kinder- und Jugendheilkunde, KinderonkologieRecruiting
- St. Anna KinderspitalRecruiting
- Hôpital Universitaire des Enfants Reine Fabiola (ULB), Pédiatrie hémato-oncologieRecruiting
- University Hospital Brussels, Pediatrische oncologieRecruiting
- Cliniques Universitaires Saint-Luc (UCL), Hématologie et oncologie pédiatriqueRecruiting
- UZ Antwerpen Kinderhemato-oncologieRecruiting
- University Hospital Gent Pediatrische hemato-oncologieRecruiting
- University Hospitals Leuven, Kinderhemato-oncologieRecruiting
- CHR Citadelle Hémato - oncologie pédiatriqueRecruiting
- CHR Citadelle Hémato - oncologie pédiatriqueRecruiting
- Hong Kong Children's Hospital
- Dept. of Pediatric Oncology, University Hospital Brno and Faculty of Medicine, Masaryk University CernopolniRecruiting
- Dept. of Pediatric Hematology and Oncology. University Hospital Motol and 2nd Medical School, Charles UniversityRecruiting
- University Hospital Aalborg, Nord, Department of PediatricsRecruiting
- Aarhus University Hospital, Department of PediatricsRecruiting
- Børneonkologisk afsnit 5054, BørneUngeKlinikken, Juliane Marie Centret, RigshospitaletRecruiting
- H.C. Andersens Children Hospital, Odense University HospitalRecruiting
- Helsinki University Hospital, Department of Pediatric Hematology and OncologyRecruiting
- Kuopio University Hospital, Department of Pediatric Hematology and OncologyRecruiting
- University Hospital of Oulu, Paediatric Haematology and OncologyRecruiting
- Tampere University Hospital, Paediatric Haematology and OncologyRecruiting
- Turku University Hospital, Paediatric and Adolescent Haematology and OncologyRecruiting
- Service d'oncolologie, Hématologie pédiatrique. CHU Amiens, Avenue René Laënnec - SALOUEL
- Pôle Femme Mère Enfant ; Unité d'Hématologie/Oncologie pédiatrique, CHU Angers
- Hématologie Oncologie pédiatrique, CHRU Besançon
- Hôpital de Enfants, Unité Onco-Hématologie Pédiatrique, Groupe Hospitalier Pellegrin
- Département de Pédiatrie et Génétique Médicale CHRU Morvan
- Unité d'hémato-immuno-oncologie pédiatrique. Centre Hospitalier Universitaire niveau 1 - bâtiment FEH
- Unité Onco- Hématologie Pédiatrique CHU Estaing 1 place Lucie-Aubrac
- Service Immuno-Hématologie Oncologie Pédiatrique
- Service onco hématologie pédiatrique CHU de Grenoble site Nord - Hôpital Couple enfant
- Unité d'hématologie pédiatrique CHRU de Lille - Hôpital Jeanne de Flandre
- Service d'Hématologie - Oncologie pédiatrique CHU Limoges - Hôpital de la mère et de l'enfant
- 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
- Service de Pédiatrie et hématologie pédiatrique, CHU de Marseille - Hôpital de la Timone
- UAM Hématologie et Oncologie Pédiatrique, CHU de Montpellier - Hôpital Arnaud de Villeneuve
- Service d'hématologie et oncologie pédiatriques, Hôpital enfant-adolescent, CHU NANTES
- Service d'hémato-oncologie pédiatrique CHU NICE - Hôpital l'Archet 2
- service d'oncologie pédiatrique, institut Curie
- Service Hémato-immuno- oncologie- CHU PARIS Armand Trousseau
- Service d' hémato-immunologie CHU Paris - Hôpital Robert Debré
- Service Oncologie-Hématologie pédiatrique CHU de Poitiers
- Service d'Hémato-Oncologie Pédiatrique- American Hospital
- Pôle pédiatrie Hémato-cancérologie pédiatrique- CHU RENNES - Hôpital sud
- Service d'Hemato-Oncologie Pediatrique CHU Rouen
- service d'oncologie pédiatrique, hopital Félix Guyon
- Pôle mère enfant-Unité Hématologie - Oncologie pédiatrique - CHU Hôpital NORD
- Service d'Onco-Hematologie Pediatrique CHU STRASBOURG -Hôpital de Hautepierre
- Service Pédiatrie - Hématologie Immunologie Oncologie - CHU Toulouse
- Service d'hémato-oncologie pédiatrique- CHU de Nancy - Hôpital de Brabois Enfant
- Dépt de Pédiatrie Gustave Roussy
- Universitätsklinikum Aachen .Klinik für Kinder - und Jugendmedizin Hämatologie / OnkologieRecruiting
- Klinikum Augsburg ,Schwäbisches Kinderkrebszentrum. I. Klinik für Kinder und Jugendliche Hämatologie / OnkologieRecruiting
- HELIOS Klinikum Berlin-Buch, Kinderklinik, Pädiatrische Hämatologie und OnkologieRecruiting
- Charité Campus Virchow-Klinikum, Zentrum für Kinder- und Jugendmedizin- Abt. Hämatologie / OnkologieRecruiting
- Evangelisches Krankenhaus Bielefeld GmbH, Klinik für Kinder- und Jugendmedizin, Hämatologie und OnkologieRecruiting
- Zentrum für Kinderheilkunde der Universität Bonn, Abt. Päd. Hämatologie / OnkologieRecruiting
- Städtisches Klinikum Braunschweig gGmbH, Zentrum für Kinder- und JugendmedizinRecruiting
- Klinikum Bremen-Mitte gGmbH, Prof.-Hess-Kinderklinik,Pädiatrische Onkologie und HämatologieRecruiting
- Klinikum Chemnitz gGmbH, Klinik für Kinder- und Jugendmedizin, Päd. Hämatologie und Onkologie
- Carl-Thiem-Klinikum, Kinderklinik, Station 5eRecruiting
- Vestische Kinderklinik, Universität Witten / HerdeckeRecruiting
- Klinikum Dortmund gGmbH, Klinik für Kinder- und Jugendmedizin, Station K1, Abt. Päd. Onkologie / HämatologieRecruiting
- Universitätsklinik Carl Gustav Carus der TU Dresden, Klinik für Kinder- und JugendmedizinRecruiting
- Universitätsklinikum Düsseldorf, Zentrum für Kinder- und Jugendmedizin, Klinik für Päd. Hämatologie und OnkologieRecruiting
- HELIOS Klinikum Erfurt GmbH, Klinik für Kinder- und Jugendmedizin, Päd. Onkologie / HämatologieRecruiting
- Universitätsklinikum Erlangen, Klinik für Kinder- und Jugendmedizin, Pädiatrische Onkologie / HämatologieRecruiting
- Universitätsklinikum Essen, Zentrum für Kinder- und Jugendmedizin, Hämatologie / OnkologieRecruiting
- Universitätsklinikum Frankfurt, Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie und OnkologieRecruiting
- Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin, Klinik IV: Päd. Hämatologie und OnkologieRecruiting
- Universitätsklinikum Gießen und Marburg, Standort Gießen, Zentrum für Kinderhämatologie und -onkologieRecruiting
- Universitätsklinikum Greifswald KdöR, Klinik und Poliklinik für Kinder- und Jugendmedizin, Abt. Pädiatrische Onkologie und HämatologieRecruiting
- Georg-August-Universität Universitäts-Kinderklinik, Pädiatrie IRecruiting
- Universitätsklinikum Halle (Saale), Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie / OnkologieRecruiting
- Universitätsklinikum Hamburg Eppendorf, Zentrum für Kinder- und Jugendmedizin, Abt. Pädiatrische Hämatologie und OnkologieRecruiting
- Medizinische Hochschule Hannover, Kinderheilkunde, Päd. Hämatologie / OnkologieRecruiting
- Universitäts-Kinderklinik Heidelberg, Abt. Hämatologie / OnkologieRecruiting
- Gemeinschaftskrankenhaus Herdecke, Kinder- und Jugendmedizin, Päd. Hämatologie / OnkologieRecruiting
- Universitätskliniken für Kinder- und Jugendmedizin, Päd. Hämatologie und Onkologie, Geb. 9Recruiting
- Universitätsklinikum Jena, Klinik für Kinder- und JugendmedizinRecruiting
- Städtisches Klinikum Karlsruhe gGmbH, Kinderklinik, Station S 24Recruiting
- Klinikum Kassel Gesundheit Nordhessen Holding AG, Klinik für pädiatrische Hämatologie und OnkologieRecruiting
- Universitätsklinikum Schleswig Holstein Campus Kiel, Klinik für Allgemeine Pädiatrie, Päd. Onkologie / HämatologieRecruiting
- Gemeinschaftsklinikum Mittelrhein Kemperhof, Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie und OnkologieRecruiting
- HELIOS Klinikum Krefeld, Zentrum für Kinder- und Jugendmedizin, Päd. Hämatologie/OnkologieRecruiting
- Klinikum der Universität zu Köln, Klinik für Kinder- und Jugendmedizin, Abt. Kinderonkologie und -hämatologie
- Universitätsklinikum Leipzig, Klinik für Kinder und Jugendliche, Abt. Päd. Hämatologie / OnkologieRecruiting
- Universitätsklinikum Schleswig Holstein Campus Lübeck, Klinik für Kinder- und Jugendmedizin, Hämatologie und OnkologieRecruiting
- Universitätsklinikum Magdeburg A. ö. R., Kinderklinik, Päd. Hämatologie / OnkologieRecruiting
- Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Zentrum für Kinder- und Jugendmedizin, Pädiatrische Hämatologie / OnkologieRecruiting
- Klinikum Mannheim gGmbH, Universitäts-Kinderklinik, Päd. Onkologie /HämatologieRecruiting
- Johannes Wesling Klinikum Minden, Klinik für Kinder- und Jugendmedizin, Päd. Hämatologie / Onkologie, Station E 22Recruiting
- Klinikum der LMU, Dr. von Haunersches Kinderspital, Pädiatrische Hämatologie / OnkologieRecruiting
- Klinikum Schwabing, Kinderklinik der TU Päd. Hämatologie / Onkologie, Station 24dRecruiting
- Universitätsklinikum Münster, Klinik für Kinder- und Jugendmedizin, Abt. Pädiatrische Hämatologie und OnkologieRecruiting
- Diakonie Neuendettelsau, Kliniken Hallerwiese / Cnopf'sche Kinderklinik, Pädiatrische Hämatologie /OnkologieRecruiting
- Klinikum Oldenburg AöR, Zentrum für Kinder- und Jugendmedizin, Abt. Hämatologie / OnkologieRecruiting
- Universitätsklinikum Regensburg, Klinik für Kinder- und Jugendmedizin, Abt. Päd. Hämatologie, Onkologie, SZTRecruiting
- Universitätsklinikum Rostock, Kinder- und Jugendklinik, Päd. Hämatologie und OnkologieRecruiting
- Asklepios Klinik St. Augustin GmbH, Kinder- und Jugendmedizin, Kinder-Hämatologie und OnkologieRecruiting
- HELIOS Kliniken Schwerin GmbH, Klinik für Kinder- und Jugendmedizin, Station A1Recruiting
- Klinikum Stuttgart, Olgahospital Zentrum für Kinder- und Jugendmedizin Pädiatrie 5 (Onkologie, Hämatologie, Immunologie)Recruiting
- Klinikum Mutterhaus der Borromäerinnen gGmbH, Pädiatrische Abteilung
- Universitätsklinik Tübingen, Klinik für Kinderheilkunde und Jugendmedizin, Päd. Hämatologie / OnkologieRecruiting
- Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin, Päd. Hämatologie und OnkologieRecruiting
- Universitätskinderklinik Würzburg, Päd. Onkologie und HämatologieRecruiting
- 2nd Dep. of Pediatrics, Semmelweis Univ
- Heim Pal Children Hospital
- Dep. of Pediatrics, Univ. of Debrecen
- Children's Treating Center, Miskolc
- Dep. of Pediatrics, University of Pecs
- Dep. of Pediatrics, Univ. of Szeged
- Our Lady's Children's Hospital Crumlin
- Children's Hospital at Soroka Medical Center
- Ruth Rappaport Children's Hospital, Rambam Medical Center
- Children's Hospital at Hadassah, Ein Kerem Medical Center
- Schneider Children's hospital, Rabin Medical Center
- Edmond and Lily Safra Children's Hospital, Sheba Medical Center
- Dana Children's Hospital, Tel-Aviv Sourasky Medical Center
- Clinica Pediatrica, Centro Regionale Oncoematologia Pediatrica- Ospedale dei Bambini "G. Salesi"
- Dipartimento Biomedicina Età Evolutiva- U.O. Pediatrica I Policlinico
- Dipartimento Pediatrico degli OO.RR. di Bergamo
- Dipartimento di Scienze Pediatriche Mediche Chirurgiche Ospedale Sant'Orsola Malpighi
- Clinica Pediatrica Ospedale Civile
- Istituto di Clinica Pediatrica- Ospedale Regionale Microcitemie
- Divisione Ematologia - Oncologia Pediatrica, Clinica Pediatrica
- U. O. di Pediatria- Azienda Ospedaliera Annunziata
- Dipartimento di Medicina Clinica e Sperimentale Sezione di Pediatria - Università di Ferrara
- Unità Autonoma di Oncoematologia Pediatrica, Dipartimento Pediatria - Azienda "A.Meyer"
- Dipartimento di Ematologia e Oncologia Pediatrica Istituto " G. Gaslini"
- Divisione di Oncologia Pediatrica Ist. Nazionale Studio e Cura Tumori
- U.O. di Ematologia, Oncologia e Trapianto-Azienda Policlinico di Modena
- Clinica Pediatrica Ospedale S. Gerardo Via Donizetti
- S.C. Ematologia Oncologica- Ospedale "Pausilipon"
- Clinica di Oncoematologia Pediatrica- Azienda Ospedaliera-Università di Padova
- Oncoematologia Pediatrica- Ospedale dei Bambini G. di Cristina
- U.O. di Pediatria e Oncoematologia Pediatrica. Az. Osp. di Parma
- Oncoematologia Pediatrica IRCCS, Policlinico San Matteo Piazzale Golgi
- Dipartimento di Ematologia -Ospedale Civile
- U.O. Pediatria Ospedale Infermi- Azienda USL Rimini
- Sezione Ematologia- Dipart. Biotecnico Cellulare ed Ematologia- Università "La Sapienza"
- Divisione di Ematologia Pediatrica- Ospedale "Bambino Gesù". Istituto di Ricerca Scientifica
- Divisione di Pediatria- Ospedale "Casa Sollievo della Sofferenza"
- Oncologia Pediatrica,- Ospedale "R. Silvestrini"
- Dip. Scienze Pediatriche e dell'Adolescenza Ospedale Infantile Regina Margherita
- U.O. Emato-Oncologia Pediatrica- Università degli studi di Trieste-Ospedale Infantile Burlo Garofolo
- U.O. Oncoematologia Pediatrica- Policlinico "G.B. Rossi"
- Princess Maxima Centre for Pediatric Oncology
- Haukeland University Hospital in BergenRecruiting
- University Hospital Northern NorwayRecruiting
- St Olavs Hospital in TrondheimRecruiting
- Department of Pediatric Oncology and Hematology, Medical University of Bialystok
- Department of Pediatric Hematology and Oncology, Nicolaus Copernicus University
- Department of Pediatric Hematology and Oncology, Center of Pediatrics and Oncology in Chorzów
- Department of Pediatrics, Hematology, Oncology and Endocrinology, Medical University of Gdansk
- Department of Pediatric Oncology and Hematology, Center of Pediatrics in Kielce
- Department of Pediatric Oncology/Hematology, Institute of Pediatrics, Medical College Jagiellonian University
- Department of Pediatric Hematology, Oncology and Transplantology, Medical University of Lublin
- Department of Pediatric Oncology and Hematology, Provincial Specialist Children's Hospital
- Department of Pediatric Oncology, Hematology and Transplantology, Poznan University of Medical Sciences
- Department of Paediatric Oncology and Haematology, University of Rzeszów, Department of Pediatrics
- Department of Pediatrics, Children Hematology nad Oncology, Pomeranian Medical University
- Department of Pediatrics, Hematology and Oncology, Medical University of Warsaw
- Department of Pediatric Oncology, Children's Memorial Health Institute
- Department of Bone Marrow Transplantation, Children Oncology and Hematology, Wroclaw Medical University
- Department of Pediatric Hematology and Oncology, Silesian Medical University in Katowice
- Department of Pediatrics, Oncology, Hematology and Diabetology, Institute of Pediatrics, Medical University of Lodz
- Centro Hospitalar e Universitário de Coimbra
- Instituto Português de Oncologia - Francisco Gentil - Libosa
- Instituto Português de Oncologia - Francisco Gentil - Porto
- Oncological center of regional Children's HospitalRecruiting
- National Center for Pediatric Hematology, Oncology and Immunology MoscowRecruiting
- Department of pediatric oncology and hematology, Children´s Faculty Hospital
- Department of pediatric hematology and oncology, National Institute of Children's Diseases
- Department of pediatric hematology and oncology, Children´s University Hospital
- Hospital General Universitario de AlicanteRecruiting
- Hospital Universitario TorrecárdenasRecruiting
- Hospital Materno-Infantil de BadajozRecruiting
- Hospital Universitario CrucesRecruiting
- Hospital Universitari Vall d'HebronRecruiting
- Hospital de la Santa Creu i Sant PauRecruiting
- Hospital Universitario DonostiaRecruiting
- Hospital Sant Joan de DéuRecruiting
- Hospital Universitario Virgen de las NievesRecruiting
- Complejo Hospitalario Universitario Insular Materno InfantilRecruiting
- Hospital General Universitario Gregorio MarañónRecruiting
- Hospital Infantil Universitario Niño JesúsRecruiting
- Hospital Universitario 12 de OctubreRecruiting
- Hospital Universitario La PazRecruiting
- Hospital Clínico Universitario Virgen de la ArrixacaRecruiting
- Hospital Regional Universitario de MálagaRecruiting
- Hospital Universitario Central de AsturiasRecruiting
- Hospital Universitari Son EspasesRecruiting
- Hospital Virgen del CaminoRecruiting
- Complejo Hospitalario Universitario de VigoRecruiting
- Hospital Universitario Nuestra Señora de CandelariaRecruiting
- Hospital Universitario Marqués de ValdecillaRecruiting
- Hospital Clínico Universitario de SantiagoRecruiting
- Hospital Universitario Virgen MacarenaRecruiting
- Hospital Universitario Virgen del RocíoRecruiting
- Hospital Virgen de la SaludRecruiting
- Hospital Clínico Universitario de ValenciaRecruiting
- Hospital Universitari i Politècnic La FeRecruiting
- Hospital Clínico Universitario de ValladolidRecruiting
- Hospital Universitario Miguel ServetRecruiting
- Barncancercentrum, Drottning Silvias Barn och Ungdomssjukhus, Sahlgrenska UniversitetssjukhusetRecruiting
- Barnonkologiska enheten, Barn och Ungdomsmedicinska kliniken, Universitetssjukhuset i LinköpingRecruiting
- Barnonkologi, Skåne UniversitetssjukhusRecruiting
- Barncanceravdelningen Astrid Lindgrens Barnsjukhus, Nya Karolinska UniversitetssjukhusetRecruiting
- Barnonkologiska avdelningen, Barn 3, Norrlands UniversitetssjukhusRecruiting
- Barnavdelningen för blod- och tumörsjukdomar 95A, Akademiska sjukhusetRecruiting
- Kantonsspital Aarau
- Universitäts-Kinderspital beider Basel (UKBB)
- Ospedale San Giovanni
- Inselspital Bern, University of Bern
- HUG Hôpitaux Universitaires de Genève
- CHUV - Centre Hospitalier Universitaire Vaudois
- Luzerner Kantonspital - Kinderspital Luzern
- Ostschweizer Kinderspital
- Universitäts-Kinderspital Zürich
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Other
Experimental
Other
Experimental
Other
Experimental
Experimental
Experimental
Arm Label
SR I/II: R1 into protocol Ia-Pred
SR I/II: R1 into protocol Ia-Dexa
SR: R1 into protocol Ia-Pred
SR: R1 into protocol Ia-Dexa
HR: R1 into "Pred" and R2 into non-HR extra-compartment phase
HR: R1 into "Dexa" and R2 into non-HR extra-compartment phase
HR: R1 into "Pred" and R2 into HR extra-compartment phase
HR: R1 into "Dexa" and R2 into HR extra-compartment phase
Arm Description
cytoreductive prephase with prednisone standard induction phase (protocol Ia-prednisone) consolidation phase (protocol Ib) non-HR extra-compartment phase (protocol M) maintenance therapy
cytoreductive prephase with prednisone experimental induction phase (protocol Ia-dexamethasone) consolidation phase (protocol Ib) non-HR extra-compartment Phase (protocol M) maintenance therapy
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
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
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
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
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
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
Outcomes
Primary Outcome Measures
Cumulative incidence of relapse with involvement of the CNS (CNS-relapse, pCICR)
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.
Estimated probability of event-free survival (pEFS)
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.
Secondary Outcome Measures
Survival (pOS)
Survival (pOS) is defined as time from diagnosis to death due to any cause or to the date of last contact for patients alive
Frequency of treatment-related toxicity overall and in specific protocol elements, randomized arms and during follow up
Frequency of treatment-related mortality overall and in specific protocol elements, randomized arms and during follow up
Frequency of adverse events of interest and severe adverse events overall
Rate of evaluable patients for risk group stratification
Cumulative incidence of relapses in association with molecular markers
Cumulative incidence of relapses in association with minimal residual disease results
Full Information
NCT ID
NCT04043494
First Posted
July 15, 2019
Last Updated
December 13, 2022
Sponsor
University Hospital Muenster
Collaborators
Deutsche Krebshilfe e.V., Bonn (Germany)
1. Study Identification
Unique Protocol Identification Number
NCT04043494
Brief Title
International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma
Acronym
LBL 2018
Official Title
LBL 2018 - International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2019 (Actual)
Primary Completion Date
November 22, 2027 (Anticipated)
Study Completion Date
November 22, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Muenster
Collaborators
Deutsche Krebshilfe e.V., Bonn (Germany)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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), PPLLSG (Poland), SEHOP (Spain) and SFCE (France). HKPHOSG (Hong Kong), HPOG (Hungary), ISPHO (Israel), NSPHO (Moscow), 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoblastic Lymphoma, Childhood
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
683 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SR I/II: R1 into protocol Ia-Pred
Arm Type
Other
Arm Description
cytoreductive prephase with prednisone
standard induction phase (protocol Ia-prednisone)
consolidation phase (protocol Ib)
non-HR extra-compartment phase (protocol M)
maintenance therapy
Arm Title
SR I/II: R1 into protocol Ia-Dexa
Arm Type
Experimental
Arm Description
cytoreductive prephase with prednisone
experimental induction phase (protocol Ia-dexamethasone)
consolidation phase (protocol Ib)
non-HR extra-compartment Phase (protocol M)
maintenance therapy
Arm Title
SR: R1 into protocol Ia-Pred
Arm Type
Other
Arm 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
Arm Title
SR: R1 into protocol Ia-Dexa
Arm Type
Experimental
Arm 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
Arm Title
HR: R1 into "Pred" and R2 into non-HR extra-compartment phase
Arm Type
Other
Arm 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
Arm Title
HR: R1 into "Dexa" and R2 into non-HR extra-compartment phase
Arm Type
Experimental
Arm 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
Arm Title
HR: R1 into "Pred" and R2 into HR extra-compartment phase
Arm Type
Experimental
Arm 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
Arm Title
HR: R1 into "Dexa" and R2 into HR extra-compartment phase
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention 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(s)
Cytarabine
Intervention 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(s)
Dexamethasone
Intervention Description
Part of the experimental therapy in Randomization R1 (Protocol Ia-Dexamethasone) and in Randomization R2 (Intensified Protocol M)
Intervention Type
Drug
Intervention Name(s)
Daunorubicin
Intervention 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(s)
Doxorubicin
Intervention Description
Part of standard chemotherapy
Intervention Type
Drug
Intervention Name(s)
Ifosfamide
Intervention Description
Part of the experimental therapy in Randomization R2 (Intensified Protocol M)
Intervention Type
Drug
Intervention Name(s)
6-Mercaptopurine
Intervention 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(s)
Methotrexate
Intervention 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(s)
PEG asparaginase
Intervention 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(s)
Prednisone
Intervention Description
Part of standard chemotherapy
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention 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(s)
Thioguanine
Intervention Description
Part of standard chemotherapy
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention 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(s)
Vindesine
Intervention Description
Part of the experimental therapy in Randomization R2 (Intensified Protocol M)
Primary Outcome Measure Information:
Title
Cumulative incidence of relapse with involvement of the CNS (CNS-relapse, pCICR)
Description
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.
Time Frame
through study completion, maximal 7.25 years
Title
Estimated probability of event-free survival (pEFS)
Description
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.
Time Frame
through study completion, maximal 7.25 years
Secondary Outcome Measure Information:
Title
Survival (pOS)
Description
Survival (pOS) is defined as time from diagnosis to death due to any cause or to the date of last contact for patients alive
Time Frame
through study completion, maximal 7.25 years
Title
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
Title
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
Title
Frequency of adverse events of interest and severe adverse events overall
Time Frame
through study completion, maximal 7.25 years
Title
Rate of evaluable patients for risk group stratification
Time Frame
during recruitment
Title
Cumulative incidence of relapses in association with molecular markers
Time Frame
through study completion, maximal 7.25 years
Title
Cumulative incidence of relapses in association with minimal residual disease results
Time Frame
through study completion, maximal 7.25 years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Birgit Burkhardt, Prof. Dr. Dr.
Phone
+49 251 83 55696
Email
LBL2018@ukmuenster.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgit Burkhardt, Prof. Dr. Dr.
Organizational Affiliation
University Hospital Muenster, Klinik für Kinder- und Jugendmedizin - Pädiatrische Hämatologie und Onkologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univ.Klinik für Kinder- und Jugendheilkunde Graz, Klin. Abteilung für pädiatrische Hämato-Onkologie
City
Graz
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Name
Univ.Klinik für Kinder- und Jugendheilkunde Innsbruck, Universitätsklinik für Pädiatrie I
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Kepler Universitätsklinikum, Med Campus IV / Onkologie
City
Linz
ZIP/Postal Code
4020
Country
Austria
Individual Site Status
Recruiting
Facility Name
LKH Salzburg, Universitätsklinik für Kinder- und Jugendheilkunde, Kinderonkologie
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Recruiting
Facility Name
St. Anna Kinderspital
City
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Name
Hôpital Universitaire des Enfants Reine Fabiola (ULB), Pédiatrie hémato-oncologie
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Individual Site Status
Recruiting
Facility Name
University Hospital Brussels, Pediatrische oncologie
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Cliniques Universitaires Saint-Luc (UCL), Hématologie et oncologie pédiatrique
City
Brussel
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Antwerpen Kinderhemato-oncologie
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Name
University Hospital Gent Pediatrische hemato-oncologie
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
University Hospitals Leuven, Kinderhemato-oncologie
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CHR Citadelle Hémato - oncologie pédiatrique
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CHR Citadelle Hémato - oncologie pédiatrique
City
Montegnée
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Hong Kong Children's Hospital
City
Hong Kong
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Dept. of Pediatric Oncology, University Hospital Brno and Faculty of Medicine, Masaryk University Cernopolni
City
Brno
ZIP/Postal Code
662 63
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Dept. of Pediatric Hematology and Oncology. University Hospital Motol and 2nd Medical School, Charles University
City
Praha
ZIP/Postal Code
160 06
Country
Czechia
Individual Site Status
Recruiting
Facility Name
University Hospital Aalborg, Nord, Department of Pediatrics
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Aarhus University Hospital, Department of Pediatrics
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Børneonkologisk afsnit 5054, BørneUngeKlinikken, Juliane Marie Centret, Rigshospitalet
City
Kobenhavn
ZIP/Postal Code
2100 Ø
Country
Denmark
Individual Site Status
Recruiting
Facility Name
H.C. Andersens Children Hospital, Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Helsinki University Hospital, Department of Pediatric Hematology and Oncology
City
Helsinki
ZIP/Postal Code
00029 HUS
Country
Finland
Individual Site Status
Recruiting
Facility Name
Kuopio University Hospital, Department of Pediatric Hematology and Oncology
City
Kuopio
ZIP/Postal Code
70029 KYS
Country
Finland
Individual Site Status
Recruiting
Facility Name
University Hospital of Oulu, Paediatric Haematology and Oncology
City
Oulu
ZIP/Postal Code
90029 OYS
Country
Finland
Individual Site Status
Recruiting
Facility Name
Tampere University Hospital, Paediatric Haematology and Oncology
City
Tampere
ZIP/Postal Code
33521 Tampere
Country
Finland
Individual Site Status
Recruiting
Facility Name
Turku University Hospital, Paediatric and Adolescent Haematology and Oncology
City
Turku
ZIP/Postal Code
20521 Turku
Country
Finland
Individual Site Status
Recruiting
Facility Name
Service d'oncolologie, Hématologie pédiatrique. CHU Amiens, Avenue René Laënnec - SALOUEL
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Pôle Femme Mère Enfant ; Unité d'Hématologie/Oncologie pédiatrique, CHU Angers
City
Angers
ZIP/Postal Code
49033
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hématologie Oncologie pédiatrique, CHRU Besançon
City
Besançon
ZIP/Postal Code
25030
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hôpital de Enfants, Unité Onco-Hématologie Pédiatrique, Groupe Hospitalier Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Département de Pédiatrie et Génétique Médicale CHRU Morvan
City
Brest
ZIP/Postal Code
29609
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Unité d'hémato-immuno-oncologie pédiatrique. Centre Hospitalier Universitaire niveau 1 - bâtiment FEH
City
Caen
ZIP/Postal Code
14033
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Unité Onco- Hématologie Pédiatrique CHU Estaing 1 place Lucie-Aubrac
City
Clermont-Ferrand
ZIP/Postal Code
63303
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Service Immuno-Hématologie Oncologie Pédiatrique
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Service onco hématologie pédiatrique CHU de Grenoble site Nord - Hôpital Couple enfant
City
Grenoble
ZIP/Postal Code
38043
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Unité d'hématologie pédiatrique CHRU de Lille - Hôpital Jeanne de Flandre
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Service d'Hématologie - Oncologie pédiatrique CHU Limoges - Hôpital de la mère et de l'enfant
City
Limoges
ZIP/Postal Code
87042
Country
France
Individual Site Status
Not yet recruiting
Facility Name
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
City
Lyon
ZIP/Postal Code
69373
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Service de Pédiatrie et hématologie pédiatrique, CHU de Marseille - Hôpital de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Individual Site Status
Not yet recruiting
Facility Name
UAM Hématologie et Oncologie Pédiatrique, CHU de Montpellier - Hôpital Arnaud de Villeneuve
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Service d'hématologie et oncologie pédiatriques, Hôpital enfant-adolescent, CHU NANTES
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Service d'hémato-oncologie pédiatrique CHU NICE - Hôpital l'Archet 2
City
Nice
ZIP/Postal Code
06200
Country
France
Individual Site Status
Not yet recruiting
Facility Name
service d'oncologie pédiatrique, institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Service Hémato-immuno- oncologie- CHU PARIS Armand Trousseau
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Service d' hémato-immunologie CHU Paris - Hôpital Robert Debré
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Service Oncologie-Hématologie pédiatrique CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Service d'Hémato-Oncologie Pédiatrique- American Hospital
City
Reims
ZIP/Postal Code
51100
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Pôle pédiatrie Hémato-cancérologie pédiatrique- CHU RENNES - Hôpital sud
City
Rennes
ZIP/Postal Code
35203
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Service d'Hemato-Oncologie Pediatrique CHU Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France
Individual Site Status
Not yet recruiting
Facility Name
service d'oncologie pédiatrique, hopital Félix Guyon
City
Saint-Denis
ZIP/Postal Code
97405
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Pôle mère enfant-Unité Hématologie - Oncologie pédiatrique - CHU Hôpital NORD
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42270
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Service d'Onco-Hematologie Pediatrique CHU STRASBOURG -Hôpital de Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Service Pédiatrie - Hématologie Immunologie Oncologie - CHU Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Service d'hémato-oncologie pédiatrique- CHU de Nancy - Hôpital de Brabois Enfant
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54511
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Dépt de Pédiatrie Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Universitätsklinikum Aachen .Klinik für Kinder - und Jugendmedizin Hämatologie / Onkologie
City
Aachen
ZIP/Postal Code
52057
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum Augsburg ,Schwäbisches Kinderkrebszentrum. I. Klinik für Kinder und Jugendliche Hämatologie / Onkologie
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Individual Site Status
Recruiting
Facility Name
HELIOS Klinikum Berlin-Buch, Kinderklinik, Pädiatrische Hämatologie und Onkologie
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Individual Site Status
Recruiting
Facility Name
Charité Campus Virchow-Klinikum, Zentrum für Kinder- und Jugendmedizin- Abt. Hämatologie / Onkologie
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Name
Evangelisches Krankenhaus Bielefeld GmbH, Klinik für Kinder- und Jugendmedizin, Hämatologie und Onkologie
City
Bielefeld
ZIP/Postal Code
33617
Country
Germany
Individual Site Status
Recruiting
Facility Name
Zentrum für Kinderheilkunde der Universität Bonn, Abt. Päd. Hämatologie / Onkologie
City
Bonn
ZIP/Postal Code
55113
Country
Germany
Individual Site Status
Recruiting
Facility Name
Städtisches Klinikum Braunschweig gGmbH, Zentrum für Kinder- und Jugendmedizin
City
Braunschweig
ZIP/Postal Code
38126
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum Bremen-Mitte gGmbH, Prof.-Hess-Kinderklinik,Pädiatrische Onkologie und Hämatologie
City
Bremen
ZIP/Postal Code
28177
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum Chemnitz gGmbH, Klinik für Kinder- und Jugendmedizin, Päd. Hämatologie und Onkologie
City
Chemnitz
ZIP/Postal Code
09116
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Carl-Thiem-Klinikum, Kinderklinik, Station 5e
City
Cottbus
ZIP/Postal Code
03048
Country
Germany
Individual Site Status
Recruiting
Facility Name
Vestische Kinderklinik, Universität Witten / Herdecke
City
Datteln
ZIP/Postal Code
45711
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum Dortmund gGmbH, Klinik für Kinder- und Jugendmedizin, Station K1, Abt. Päd. Onkologie / Hämatologie
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinik Carl Gustav Carus der TU Dresden, Klinik für Kinder- und Jugendmedizin
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Düsseldorf, Zentrum für Kinder- und Jugendmedizin, Klinik für Päd. Hämatologie und Onkologie
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Individual Site Status
Recruiting
Facility Name
HELIOS Klinikum Erfurt GmbH, Klinik für Kinder- und Jugendmedizin, Päd. Onkologie / Hämatologie
City
Erfurt
ZIP/Postal Code
99089
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Erlangen, Klinik für Kinder- und Jugendmedizin, Pädiatrische Onkologie / Hämatologie
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Essen, Zentrum für Kinder- und Jugendmedizin, Hämatologie / Onkologie
City
Essen
ZIP/Postal Code
45122
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Frankfurt, Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie und Onkologie
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin, Klinik IV: Päd. Hämatologie und Onkologie
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Gießen und Marburg, Standort Gießen, Zentrum für Kinderhämatologie und -onkologie
City
Gießen
ZIP/Postal Code
35385
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Greifswald KdöR, Klinik und Poliklinik für Kinder- und Jugendmedizin, Abt. Pädiatrische Onkologie und Hämatologie
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Individual Site Status
Recruiting
Facility Name
Georg-August-Universität Universitäts-Kinderklinik, Pädiatrie I
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Halle (Saale), Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie / Onkologie
City
Halle
ZIP/Postal Code
06120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Hamburg Eppendorf, Zentrum für Kinder- und Jugendmedizin, Abt. Pädiatrische Hämatologie und Onkologie
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Name
Medizinische Hochschule Hannover, Kinderheilkunde, Päd. Hämatologie / Onkologie
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitäts-Kinderklinik Heidelberg, Abt. Hämatologie / Onkologie
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Gemeinschaftskrankenhaus Herdecke, Kinder- und Jugendmedizin, Päd. Hämatologie / Onkologie
City
Herdecke
ZIP/Postal Code
58313
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätskliniken für Kinder- und Jugendmedizin, Päd. Hämatologie und Onkologie, Geb. 9
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Jena, Klinik für Kinder- und Jugendmedizin
City
Jena
ZIP/Postal Code
07745
Country
Germany
Individual Site Status
Recruiting
Facility Name
Städtisches Klinikum Karlsruhe gGmbH, Kinderklinik, Station S 24
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum Kassel Gesundheit Nordhessen Holding AG, Klinik für pädiatrische Hämatologie und Onkologie
City
Kassel
ZIP/Postal Code
34125
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Schleswig Holstein Campus Kiel, Klinik für Allgemeine Pädiatrie, Päd. Onkologie / Hämatologie
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Name
Gemeinschaftsklinikum Mittelrhein Kemperhof, Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie und Onkologie
City
Koblenz
ZIP/Postal Code
56073
Country
Germany
Individual Site Status
Recruiting
Facility Name
HELIOS Klinikum Krefeld, Zentrum für Kinder- und Jugendmedizin, Päd. Hämatologie/Onkologie
City
Krefeld
ZIP/Postal Code
47805
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum der Universität zu Köln, Klinik für Kinder- und Jugendmedizin, Abt. Kinderonkologie und -hämatologie
City
Köln
ZIP/Postal Code
50924
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitätsklinikum Leipzig, Klinik für Kinder und Jugendliche, Abt. Päd. Hämatologie / Onkologie
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Schleswig Holstein Campus Lübeck, Klinik für Kinder- und Jugendmedizin, Hämatologie und Onkologie
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Magdeburg A. ö. R., Kinderklinik, Päd. Hämatologie / Onkologie
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Zentrum für Kinder- und Jugendmedizin, Pädiatrische Hämatologie / Onkologie
City
Mainz
ZIP/Postal Code
55101
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum Mannheim gGmbH, Universitäts-Kinderklinik, Päd. Onkologie /Hämatologie
City
Manheim
ZIP/Postal Code
68167
Country
Germany
Individual Site Status
Recruiting
Facility Name
Johannes Wesling Klinikum Minden, Klinik für Kinder- und Jugendmedizin, Päd. Hämatologie / Onkologie, Station E 22
City
Minden
ZIP/Postal Code
32429
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum der LMU, Dr. von Haunersches Kinderspital, Pädiatrische Hämatologie / Onkologie
City
München
ZIP/Postal Code
80337
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum Schwabing, Kinderklinik der TU Päd. Hämatologie / Onkologie, Station 24d
City
München
ZIP/Postal Code
80804
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Münster, Klinik für Kinder- und Jugendmedizin, Abt. Pädiatrische Hämatologie und Onkologie
City
Münster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Name
Diakonie Neuendettelsau, Kliniken Hallerwiese / Cnopf'sche Kinderklinik, Pädiatrische Hämatologie /Onkologie
City
Nürnberg
ZIP/Postal Code
90419
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum Oldenburg AöR, Zentrum für Kinder- und Jugendmedizin, Abt. Hämatologie / Onkologie
City
Oldenburg
ZIP/Postal Code
26133
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Regensburg, Klinik für Kinder- und Jugendmedizin, Abt. Päd. Hämatologie, Onkologie, SZT
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Rostock, Kinder- und Jugendklinik, Päd. Hämatologie und Onkologie
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Individual Site Status
Recruiting
Facility Name
Asklepios Klinik St. Augustin GmbH, Kinder- und Jugendmedizin, Kinder-Hämatologie und Onkologie
City
Sankt Augustin
ZIP/Postal Code
53757
Country
Germany
Individual Site Status
Recruiting
Facility Name
HELIOS Kliniken Schwerin GmbH, Klinik für Kinder- und Jugendmedizin, Station A1
City
Schwerin
ZIP/Postal Code
19049
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum Stuttgart, Olgahospital Zentrum für Kinder- und Jugendmedizin Pädiatrie 5 (Onkologie, Hämatologie, Immunologie)
City
Stuttgart
ZIP/Postal Code
70174
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum Mutterhaus der Borromäerinnen gGmbH, Pädiatrische Abteilung
City
Trier
ZIP/Postal Code
54290
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Universitätsklinik Tübingen, Klinik für Kinderheilkunde und Jugendmedizin, Päd. Hämatologie / Onkologie
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin, Päd. Hämatologie und Onkologie
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätskinderklinik Würzburg, Päd. Onkologie und Hämatologie
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Recruiting
Facility Name
2nd Dep. of Pediatrics, Semmelweis Univ
City
Budapest
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Heim Pal Children Hospital
City
Budapest
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Dep. of Pediatrics, Univ. of Debrecen
City
Debrecen
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Children's Treating Center, Miskolc
City
Miskolc
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Dep. of Pediatrics, University of Pecs
City
Pécs
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Dep. of Pediatrics, Univ. of Szeged
City
Szeged
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Our Lady's Children's Hospital Crumlin
City
Dublin
Country
Ireland
Individual Site Status
Not yet recruiting
Facility Name
Children's Hospital at Soroka Medical Center
City
Be'er Sheva
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Ruth Rappaport Children's Hospital, Rambam Medical Center
City
Haifa
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Children's Hospital at Hadassah, Ein Kerem Medical Center
City
Jerusalem
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Schneider Children's hospital, Rabin Medical Center
City
Petah tikva
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Edmond and Lily Safra Children's Hospital, Sheba Medical Center
City
Ramat Gan
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Dana Children's Hospital, Tel-Aviv Sourasky Medical Center
City
Tel Aviv
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Clinica Pediatrica, Centro Regionale Oncoematologia Pediatrica- Ospedale dei Bambini "G. Salesi"
City
Ancona
ZIP/Postal Code
60123
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Dipartimento Biomedicina Età Evolutiva- U.O. Pediatrica I Policlinico
City
Bari
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Dipartimento Pediatrico degli OO.RR. di Bergamo
City
Bergamo
ZIP/Postal Code
24100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Dipartimento di Scienze Pediatriche Mediche Chirurgiche Ospedale Sant'Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Clinica Pediatrica Ospedale Civile
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Istituto di Clinica Pediatrica- Ospedale Regionale Microcitemie
City
Cagliari
ZIP/Postal Code
09121
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Divisione Ematologia - Oncologia Pediatrica, Clinica Pediatrica
City
Catania
ZIP/Postal Code
95123
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
U. O. di Pediatria- Azienda Ospedaliera Annunziata
City
Cosenza
ZIP/Postal Code
87100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Dipartimento di Medicina Clinica e Sperimentale Sezione di Pediatria - Università di Ferrara
City
Ferrara
ZIP/Postal Code
44100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Unità Autonoma di Oncoematologia Pediatrica, Dipartimento Pediatria - Azienda "A.Meyer"
City
Firenze
ZIP/Postal Code
50132
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Dipartimento di Ematologia e Oncologia Pediatrica Istituto " G. Gaslini"
City
Genova
ZIP/Postal Code
16148
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Divisione di Oncologia Pediatrica Ist. Nazionale Studio e Cura Tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
U.O. di Ematologia, Oncologia e Trapianto-Azienda Policlinico di Modena
City
Modena
ZIP/Postal Code
41100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Clinica Pediatrica Ospedale S. Gerardo Via Donizetti
City
Monza
ZIP/Postal Code
20052
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
S.C. Ematologia Oncologica- Ospedale "Pausilipon"
City
Napoli
ZIP/Postal Code
80123
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Clinica di Oncoematologia Pediatrica- Azienda Ospedaliera-Università di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Oncoematologia Pediatrica- Ospedale dei Bambini G. di Cristina
City
Palermo
ZIP/Postal Code
90100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
U.O. di Pediatria e Oncoematologia Pediatrica. Az. Osp. di Parma
City
Parma
ZIP/Postal Code
43100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Oncoematologia Pediatrica IRCCS, Policlinico San Matteo Piazzale Golgi
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Dipartimento di Ematologia -Ospedale Civile
City
Pescara
ZIP/Postal Code
65123
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
U.O. Pediatria Ospedale Infermi- Azienda USL Rimini
City
Rimini
ZIP/Postal Code
47900
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Sezione Ematologia- Dipart. Biotecnico Cellulare ed Ematologia- Università "La Sapienza"
City
Roma
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Divisione di Ematologia Pediatrica- Ospedale "Bambino Gesù". Istituto di Ricerca Scientifica
City
Roma
ZIP/Postal Code
00165
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Divisione di Pediatria- Ospedale "Casa Sollievo della Sofferenza"
City
San Giovanni Rotondo
ZIP/Postal Code
71013
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Oncologia Pediatrica,- Ospedale "R. Silvestrini"
City
San Sisto
ZIP/Postal Code
06080
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Dip. Scienze Pediatriche e dell'Adolescenza Ospedale Infantile Regina Margherita
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
U.O. Emato-Oncologia Pediatrica- Università degli studi di Trieste-Ospedale Infantile Burlo Garofolo
City
Trieste
ZIP/Postal Code
34137
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
U.O. Oncoematologia Pediatrica- Policlinico "G.B. Rossi"
City
Verona
ZIP/Postal Code
37134
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Princess Maxima Centre for Pediatric Oncology
City
Utrecht
ZIP/Postal Code
3584CS
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Haukeland University Hospital in Bergen
City
Bergen
Country
Norway
Individual Site Status
Recruiting
Facility Name
University Hospital Northern Norway
City
Tromsø
Country
Norway
Individual Site Status
Recruiting
Facility Name
St Olavs Hospital in Trondheim
City
Trondheim
Country
Norway
Individual Site Status
Recruiting
Facility Name
Department of Pediatric Oncology and Hematology, Medical University of Bialystok
City
Białystok
ZIP/Postal Code
15-247
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Department of Pediatric Hematology and Oncology, Nicolaus Copernicus University
City
Bydgoszcz
ZIP/Postal Code
85-094
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Department of Pediatric Hematology and Oncology, Center of Pediatrics and Oncology in Chorzów
City
Chorzów
ZIP/Postal Code
41-500
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Department of Pediatrics, Hematology, Oncology and Endocrinology, Medical University of Gdansk
City
Gdańsk
ZIP/Postal Code
20-211
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Department of Pediatric Oncology and Hematology, Center of Pediatrics in Kielce
City
Kielce
ZIP/Postal Code
25-736
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Department of Pediatric Oncology/Hematology, Institute of Pediatrics, Medical College Jagiellonian University
City
Kraków
ZIP/Postal Code
30-663
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Department of Pediatric Hematology, Oncology and Transplantology, Medical University of Lublin
City
Lublin
ZIP/Postal Code
20-093
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Department of Pediatric Oncology and Hematology, Provincial Specialist Children's Hospital
City
Olsztyn
ZIP/Postal Code
10-561
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Department of Pediatric Oncology, Hematology and Transplantology, Poznan University of Medical Sciences
City
Poznań
ZIP/Postal Code
60-572
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Department of Paediatric Oncology and Haematology, University of Rzeszów, Department of Pediatrics
City
Rzeszów
ZIP/Postal Code
35-301
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Department of Pediatrics, Children Hematology nad Oncology, Pomeranian Medical University
City
Szczecin
ZIP/Postal Code
71-242
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Department of Pediatrics, Hematology and Oncology, Medical University of Warsaw
City
Warsaw
ZIP/Postal Code
00-576
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Department of Pediatric Oncology, Children's Memorial Health Institute
City
Warsaw
ZIP/Postal Code
04-576
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Department of Bone Marrow Transplantation, Children Oncology and Hematology, Wroclaw Medical University
City
Wrocław
ZIP/Postal Code
50-556
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Department of Pediatric Hematology and Oncology, Silesian Medical University in Katowice
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Department of Pediatrics, Oncology, Hematology and Diabetology, Institute of Pediatrics, Medical University of Lodz
City
Łódź
ZIP/Postal Code
91-138
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Centro Hospitalar e Universitário de Coimbra
City
Coimbra
ZIP/Postal Code
3000-602
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Name
Instituto Português de Oncologia - Francisco Gentil - Libosa
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Name
Instituto Português de Oncologia - Francisco Gentil - Porto
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Name
Oncological center of regional Children's Hospital
City
Ekaterinburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
National Center for Pediatric Hematology, Oncology and Immunology Moscow
City
Moscow
ZIP/Postal Code
117198
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Department of pediatric oncology and hematology, Children´s Faculty Hospital
City
Banská Bystrica
ZIP/Postal Code
974 09
Country
Slovakia
Individual Site Status
Not yet recruiting
Facility Name
Department of pediatric hematology and oncology, National Institute of Children's Diseases
City
Bratislava
ZIP/Postal Code
833 40
Country
Slovakia
Individual Site Status
Not yet recruiting
Facility Name
Department of pediatric hematology and oncology, Children´s University Hospital
City
Košice
ZIP/Postal Code
04011
Country
Slovakia
Individual Site Status
Not yet recruiting
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Torrecárdenas
City
Almería
ZIP/Postal Code
04009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Materno-Infantil de Badajoz
City
Badajoz
ZIP/Postal Code
06010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Cruces
City
Baracaldo
ZIP/Postal Code
48903
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Donostia
City
Donostia
ZIP/Postal Code
20014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Sant Joan de Déu
City
Esplugues De Llobregat
ZIP/Postal Code
08950
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Complejo Hospitalario Universitario Insular Materno Infantil
City
Las Palmas De Gran Canaria
ZIP/Postal Code
35016
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Infantil Universitario Niño Jesús
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clínico Universitario Virgen de la Arrixaca
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Regional Universitario de Málaga
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Son Espases
City
Palma De Mallorca
ZIP/Postal Code
07120
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Virgen del Camino
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Complejo Hospitalario Universitario de Vigo
City
Pontevedra
ZIP/Postal Code
36036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Nuestra Señora de Candelaria
City
Santa Cruz De Tenerife
ZIP/Postal Code
38010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
ZIP/Postal Code
390008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clínico Universitario de Santiago
City
Santiago De Compostela
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Virgen de la Salud
City
Toledo
ZIP/Postal Code
45004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari i Politècnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clínico Universitario de Valladolid
City
Valladolid
ZIP/Postal Code
47003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Barncancercentrum, Drottning Silvias Barn och Ungdomssjukhus, Sahlgrenska Universitetssjukhuset
City
Göteborg
ZIP/Postal Code
416 85
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Barnonkologiska enheten, Barn och Ungdomsmedicinska kliniken, Universitetssjukhuset i Linköping
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Barnonkologi, Skåne Universitetssjukhus
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Barncanceravdelningen Astrid Lindgrens Barnsjukhus, Nya Karolinska Universitetssjukhuset
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Barnonkologiska avdelningen, Barn 3, Norrlands Universitetssjukhus
City
Umeå
ZIP/Postal Code
901 85
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Barnavdelningen för blod- och tumörsjukdomar 95A, Akademiska sjukhuset
City
Uppsala
ZIP/Postal Code
752 39
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Kantonsspital Aarau
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Name
Universitäts-Kinderspital beider Basel (UKBB)
City
Basel
ZIP/Postal Code
4056
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Name
Ospedale San Giovanni
City
Bellinzona
ZIP/Postal Code
6500
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Name
Inselspital Bern, University of Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Name
HUG Hôpitaux Universitaires de Genève
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Name
CHUV - Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Name
Luzerner Kantonspital - Kinderspital Luzern
City
Luzern
ZIP/Postal Code
6000
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Name
Ostschweizer Kinderspital
City
Sankt Gallen
ZIP/Postal Code
9006
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Name
Universitäts-Kinderspital Zürich
City
Zürich
ZIP/Postal Code
8032
Country
Switzerland
Individual Site Status
Not yet recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33152759
Citation
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.
Results Reference
derived
Learn more about this trial
International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma
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