Clinical trial NCT04043494: International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma
Official title: LBL 2018 - International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Lymphoblastic Lymphoma, Childhood
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: Deutsche Krebshilfe e.V., Bonn (Germany)
First posted: 2019-08-02
Enrollment: 683
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Cumulative incidence of relapse with involvement of the CNS (CNS-relapse, pCICR)
timeFrame: through study completion, maximal 7.25 years
measure: Estimated probability of event-free survival (pEFS)
timeFrame: through study completion, maximal 7.25 years
Secondary outcomes:
measure: Survival (pOS)
timeFrame: through study completion, maximal 7.25 years
measure: Frequency of treatment-related toxicity overall and in specific protocol elements, randomized arms and during follow up
timeFrame: through study completion, maximal 7.25 years
measure: Frequency of treatment-related mortality overall and in specific protocol elements, randomized arms and during follow up
timeFrame: through study completion, maximal 7.25 years
measure: Frequency of adverse events of interest and severe adverse events overall
timeFrame: through study completion, maximal 7.25 years
measure: Rate of evaluable patients for risk group stratification
timeFrame: during recruitment
measure: Cumulative incidence of relapses in association with molecular markers
timeFrame: through study completion, maximal 7.25 years
measure: Cumulative incidence of relapses in association with minimal residual disease results
timeFrame: through study completion, maximal 7.25 years
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Univ.Klinik für Kinder- und Jugendheilkunde Graz, Klin. Abteilung für pädiatrische Hämato-Onkologie
city: Innsbruck
country: Austria
facility: Univ.Klinik für Kinder- und Jugendheilkunde Innsbruck, Universitätsklinik für Pädiatrie I
city: Linz
country: Austria
facility: Kepler Universitätsklinikum, Med Campus IV / Onkologie
city: Salzburg
country: Austria
facility: LKH Salzburg, Universitätsklinik für Kinder- und Jugendheilkunde, Kinderonkologie
city: Wien
country: Austria
facility: St. Anna Kinderspital
city: Brussels
country: Belgium
facility: Hôpital Universitaire des Enfants Reine Fabiola (ULB), Pédiatrie hémato-oncologie
city: Brussel
country: Belgium
facility: University Hospital Brussels, Pediatrische oncologie
city: Brussel
country: Belgium
facility: Cliniques Universitaires Saint-Luc (UCL), Hématologie et oncologie pédiatrique
city: Edegem
country: Belgium
facility: UZ Antwerpen Kinderhemato-oncologie
city: Gent
country: Belgium
facility: University Hospital Gent Pediatrische hemato-oncologie
city: Leuven
country: Belgium
facility: University Hospitals Leuven, Kinderhemato-oncologie
city: Liège
country: Belgium
facility: CHR Citadelle Hémato - oncologie pédiatrique
city: Montegnée
country: Belgium
facility: CHR Citadelle Hémato - oncologie pédiatrique
city: Hong Kong
country: China
facility: Hong Kong Children's Hospital
city: Brno
country: Czechia
facility: Dept. of Pediatric Oncology, University Hospital Brno and Faculty of Medicine, Masaryk University Cernopolni
city: Praha
country: Czechia
facility: Dept. of Pediatric Hematology and Oncology. University Hospital Motol and 2nd Medical School, Charles University
city: Aalborg
country: Denmark
facility: University Hospital Aalborg, Nord, Department of Pediatrics
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Department of Pediatrics
city: Kobenhavn
country: Denmark
facility: Børneonkologisk afsnit 5054, BørneUngeKlinikken, Juliane Marie Centret, Rigshospitalet
city: Odense
country: Denmark
facility: H.C. Andersens Children Hospital, Odense University Hospital
city: Helsinki
country: Finland
facility: Helsinki University Hospital, Department of Pediatric Hematology and Oncology
city: Kuopio
country: Finland
facility: Kuopio University Hospital, Department of Pediatric Hematology and Oncology
city: Oulu
country: Finland
facility: University Hospital of Oulu, Paediatric Haematology and Oncology
city: Tampere
country: Finland
facility: Tampere University Hospital, Paediatric Haematology and Oncology
city: Turku
country: Finland
facility: Turku University Hospital, Paediatric and Adolescent Haematology and Oncology
city: Amiens
country: France
facility: Service d'oncolologie, Hématologie pédiatrique. CHU Amiens, Avenue René Laënnec - SALOUEL
city: Angers
country: France
facility: Pôle Femme Mère Enfant ; Unité d'Hématologie/Oncologie pédiatrique, CHU Angers
city: Besançon
country: France
facility: Hématologie Oncologie pédiatrique, CHRU Besançon
city: Bordeaux
country: France
facility: Hôpital de Enfants, Unité Onco-Hématologie Pédiatrique, Groupe Hospitalier Pellegrin
city: Brest
country: France
facility: Département de Pédiatrie et Génétique Médicale CHRU Morvan
city: Caen
country: France
facility: Unité d'hémato-immuno-oncologie pédiatrique. Centre Hospitalier Universitaire niveau 1 - bâtiment FEH
city: Clermont-Ferrand
country: France
facility: Unité Onco- Hématologie Pédiatrique CHU Estaing 1 place Lucie-Aubrac
city: Dijon
country: France
facility: Service Immuno-Hématologie Oncologie Pédiatrique
city: Grenoble
country: France
facility: Service onco hématologie pédiatrique CHU de Grenoble site Nord - Hôpital Couple enfant
city: Lille
country: France
facility: Unité d'hématologie pédiatrique CHRU de Lille - Hôpital Jeanne de Flandre
city: Limoges
country: France
facility: Service d'Hématologie - Oncologie pédiatrique CHU Limoges - Hôpital de la mère et de l'enfant
city: Lyon
country: France
facility: 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: Marseille
country: France
facility: Service de Pédiatrie et hématologie pédiatrique, CHU de Marseille - Hôpital de la Timone
city: Montpellier
country: France
facility: UAM Hématologie et Oncologie Pédiatrique, CHU de Montpellier - Hôpital Arnaud de Villeneuve
city: Nantes
country: France
facility: Service d'hématologie et oncologie pédiatriques, Hôpital enfant-adolescent, CHU NANTES
city: Nice
country: France
facility: Service d'hémato-oncologie pédiatrique CHU NICE - Hôpital l'Archet 2
city: Paris
country: France
facility: service d'oncologie pédiatrique, institut Curie
city: Paris
country: France
facility: Service Hémato-immuno- oncologie- CHU PARIS Armand Trousseau
city: Paris
country: France
facility: Service d' hémato-immunologie CHU Paris - Hôpital Robert Debré
city: Poitiers
country: France
facility: Service Oncologie-Hématologie pédiatrique CHU de Poitiers
city: Reims
country: France
facility: Service d'Hémato-Oncologie Pédiatrique- American Hospital
city: Rennes
country: France
facility: Pôle pédiatrie Hémato-cancérologie pédiatrique- CHU RENNES - Hôpital sud
city: Rouen
country: France
facility: Service d'Hemato-Oncologie Pediatrique CHU Rouen
city: Saint-Denis
country: France
facility: service d'oncologie pédiatrique, hopital Félix Guyon
city: Saint-Priest-en-Jarez
country: France
facility: Pôle mère enfant-Unité Hématologie - Oncologie pédiatrique - CHU Hôpital NORD
city: Strasbourg
country: France
facility: Service d'Onco-Hematologie Pediatrique CHU STRASBOURG -Hôpital de Hautepierre
city: Toulouse
country: France
facility: Service Pédiatrie - Hématologie Immunologie Oncologie - CHU Toulouse
city: Vandœuvre-lès-Nancy
country: France
facility: Service d'hémato-oncologie pédiatrique- CHU de Nancy - Hôpital de Brabois Enfant
city: Villejuif
country: France
facility: Dépt de Pédiatrie Gustave Roussy
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen .Klinik für Kinder - und Jugendmedizin Hämatologie / Onkologie
city: Augsburg
country: Germany
facility: Klinikum Augsburg ,Schwäbisches Kinderkrebszentrum. I. Klinik für Kinder und Jugendliche Hämatologie / Onkologie
city: Berlin
country: Germany
facility: HELIOS Klinikum Berlin-Buch, Kinderklinik, Pädiatrische Hämatologie und Onkologie
city: Berlin
country: Germany
facility: Charité Campus Virchow-Klinikum, Zentrum für Kinder- und Jugendmedizin- Abt. Hämatologie / Onkologie
city: Bielefeld
country: Germany
facility: Evangelisches Krankenhaus Bielefeld GmbH, Klinik für Kinder- und Jugendmedizin, Hämatologie und Onkologie
city: Bonn
country: Germany
facility: Zentrum für Kinderheilkunde der Universität Bonn, Abt. Päd. Hämatologie / Onkologie
city: Braunschweig
country: Germany
facility: Städtisches Klinikum Braunschweig gGmbH, Zentrum für Kinder- und Jugendmedizin
city: Bremen
country: Germany
facility: Klinikum Bremen-Mitte gGmbH, Prof.-Hess-Kinderklinik,Pädiatrische Onkologie und Hämatologie
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH, Klinik für Kinder- und Jugendmedizin, Päd. Hämatologie und Onkologie
city: Cottbus
country: Germany
facility: Carl-Thiem-Klinikum, Kinderklinik, Station 5e
city: Datteln
country: Germany
facility: Vestische Kinderklinik, Universität Witten / Herdecke
city: Dortmund
country: Germany
facility: Klinikum Dortmund gGmbH, Klinik für Kinder- und Jugendmedizin, Station K1, Abt. Päd. Onkologie / Hämatologie
city: Dresden
country: Germany
facility: Universitätsklinik Carl Gustav Carus der TU Dresden, Klinik für Kinder- und Jugendmedizin
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf, Zentrum für Kinder- und Jugendmedizin, Klinik für Päd. Hämatologie und Onkologie
city: Erfurt
country: Germany
facility: HELIOS Klinikum Erfurt GmbH, Klinik für Kinder- und Jugendmedizin, Päd. Onkologie / Hämatologie
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen, Klinik für Kinder- und Jugendmedizin, Pädiatrische Onkologie / Hämatologie
city: Essen
country: Germany
facility: Universitätsklinikum Essen, Zentrum für Kinder- und Jugendmedizin, Hämatologie / Onkologie
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt, Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie und Onkologie
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin, Klinik IV: Päd. Hämatologie und Onkologie
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen und Marburg, Standort Gießen, Zentrum für Kinderhämatologie und -onkologie
city: Greifswald
country: Germany
facility: Universitätsklinikum Greifswald KdöR, Klinik und Poliklinik für Kinder- und Jugendmedizin, Abt. Pädiatrische Onkologie und Hämatologie
city: Göttingen
country: Germany
facility: Georg-August-Universität Universitäts-Kinderklinik, Pädiatrie I
city: Halle
country: Germany
facility: Universitätsklinikum Halle (Saale), Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie / Onkologie
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg Eppendorf, Zentrum für Kinder- und Jugendmedizin, Abt. Pädiatrische Hämatologie und Onkologie
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover, Kinderheilkunde, Päd. Hämatologie / Onkologie
city: Heidelberg
country: Germany
facility: Universitäts-Kinderklinik Heidelberg, Abt. Hämatologie / Onkologie
city: Herdecke
country: Germany
facility: Gemeinschaftskrankenhaus Herdecke, Kinder- und Jugendmedizin, Päd. Hämatologie / Onkologie
city: Homburg
country: Germany
facility: Universitätskliniken für Kinder- und Jugendmedizin, Päd. Hämatologie und Onkologie, Geb. 9
city: Jena
country: Germany
facility: Universitätsklinikum Jena, Klinik für Kinder- und Jugendmedizin
city: Karlsruhe
country: Germany
facility: Städtisches Klinikum Karlsruhe gGmbH, Kinderklinik, Station S 24
city: Kassel
country: Germany
facility: Klinikum Kassel Gesundheit Nordhessen Holding AG, Klinik für pädiatrische Hämatologie und Onkologie
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig Holstein Campus Kiel, Klinik für Allgemeine Pädiatrie, Päd. Onkologie / Hämatologie
city: Koblenz
country: Germany
facility: Gemeinschaftsklinikum Mittelrhein Kemperhof, Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie und Onkologie
city: Krefeld
country: Germany
facility: HELIOS Klinikum Krefeld, Zentrum für Kinder- und Jugendmedizin, Päd. Hämatologie/Onkologie
city: Köln
country: Germany
facility: Klinikum der Universität zu Köln, Klinik für Kinder- und Jugendmedizin, Abt. Kinderonkologie und -hämatologie
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig, Klinik für Kinder und Jugendliche, Abt. Päd. Hämatologie / Onkologie
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig Holstein Campus Lübeck, Klinik für Kinder- und Jugendmedizin, Hämatologie und Onkologie
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg A. ö. R., Kinderklinik, Päd. Hämatologie / Onkologie
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Zentrum für Kinder- und Jugendmedizin, Pädiatrische Hämatologie / Onkologie
city: Manheim
country: Germany
facility: Klinikum Mannheim gGmbH, Universitäts-Kinderklinik, Päd. Onkologie /Hämatologie
city: Minden
country: Germany
facility: Johannes Wesling Klinikum Minden, Klinik für Kinder- und Jugendmedizin, Päd. Hämatologie / Onkologie, Station E 22
city: München
country: Germany
facility: Klinikum der LMU, Dr. von Haunersches Kinderspital, Pädiatrische Hämatologie / Onkologie
city: München
country: Germany
facility: Klinikum Schwabing, Kinderklinik der TU Päd. Hämatologie / Onkologie, Station 24d
city: Münster
country: Germany
facility: Universitätsklinikum Münster, Klinik für Kinder- und Jugendmedizin, Abt. Pädiatrische Hämatologie und Onkologie
city: Nürnberg
country: Germany
facility: Diakonie Neuendettelsau, Kliniken Hallerwiese / Cnopf'sche Kinderklinik, Pädiatrische Hämatologie /Onkologie
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg AöR, Zentrum für Kinder- und Jugendmedizin, Abt. Hämatologie / Onkologie
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg, Klinik für Kinder- und Jugendmedizin, Abt. Päd. Hämatologie, Onkologie, SZT
city: Rostock
country: Germany
facility: Universitätsklinikum Rostock, Kinder- und Jugendklinik, Päd. Hämatologie und Onkologie
city: Sankt Augustin
country: Germany
facility: Asklepios Klinik St. Augustin GmbH, Kinder- und Jugendmedizin, Kinder-Hämatologie und Onkologie
city: Schwerin
country: Germany
facility: HELIOS Kliniken Schwerin GmbH, Klinik für Kinder- und Jugendmedizin, Station A1
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart, Olgahospital Zentrum für Kinder- und Jugendmedizin Pädiatrie 5 (Onkologie, Hämatologie, Immunologie)
city: Trier
country: Germany
facility: Klinikum Mutterhaus der Borromäerinnen gGmbH, Pädiatrische Abteilung
city: Tübingen
country: Germany
facility: Universitätsklinik Tübingen, Klinik für Kinderheilkunde und Jugendmedizin, Päd. Hämatologie / Onkologie
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin, Päd. Hämatologie und Onkologie
city: Würzburg
country: Germany
facility: Universitätskinderklinik Würzburg, Päd. Onkologie und Hämatologie
city: Budapest
country: Hungary
facility: 2nd Dep. of Pediatrics, Semmelweis Univ
city: Budapest
country: Hungary
facility: Heim Pal Children Hospital
city: Debrecen
country: Hungary
facility: Dep. of Pediatrics, Univ. of Debrecen
city: Miskolc
country: Hungary
facility: Children's Treating Center, Miskolc
city: Pécs
country: Hungary
facility: Dep. of Pediatrics, University of Pecs
city: Szeged
country: Hungary
facility: Dep. of Pediatrics, Univ. of Szeged
city: Dublin
country: Ireland
facility: Our Lady's Children's Hospital Crumlin
city: Be'er Sheva
country: Israel
facility: Children's Hospital at Soroka Medical Center
city: Haifa
country: Israel
facility: Ruth Rappaport Children's Hospital, Rambam Medical Center
city: Jerusalem
country: Israel
facility: Children's Hospital at Hadassah, Ein Kerem Medical Center
city: Petah tikva
country: Israel
facility: Schneider Children's hospital, Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Edmond and Lily Safra Children's Hospital, Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Dana Children's Hospital, Tel-Aviv Sourasky Medical Center
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Delle Marche
city: Bari
country: Italy
facility: University Hospital Consorziale Policlinico
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni XXIII
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria Di Bologna IRCCS
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
city: Cagliari
country: Italy
facility: ARNAS G. Brotzu
city: Catania
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
city: Cona
country: Italy
facility: University Hospital Of Ferrara
city: Cosenza
country: Italy
facility: U. O. di Pediatria- Azienda Ospedaliera Annunziata
city: Ferrara
country: Italy
facility: Dipartimento di Medicina Clinica e Sperimentale Sezione di Pediatria - Università di Ferrara
city: Florence
country: Italy
facility: Azienda Ospedaliera Universitaria Meyer IRCCS
city: Genova
country: Italy
facility: Giannina Gaslini Institute For Scientific Hospitalization And Care
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Modena
country: Italy
facility: Azienda Ospedaliero Universitaria di Modena
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo Dei Tintori
city: Naples
country: Italy
facility: L'Azienda Ospedaliera Di Rilievo Nazionale Santobono-Pausilipon
city: Napoli
country: Italy
facility: S.C. Ematologia Oncologica- Ospedale "Pausilipon"
city: Padova
country: Italy
facility: Azienda Ospedale-Università Padova
city: Palermo
country: Italy
facility: ARNAS Civico Di Cristina Benfratelli
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria di Parma
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Perugia
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Pescara
country: Italy
facility: Azienda Sanitaria Locale Di Pescara
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Rimini
country: Italy
facility: Azienda Unità Sanitaria della Romagna
city: Roma
country: Italy
facility: Sezione Ematologia- Dipart. Biotecnico Cellulare ed Ematologia- Università "La Sapienza"
city: Roma
country: Italy
facility: Ospedale Pediatrico Bambino Gesù
city: San Giovanni Rotondo
country: Italy
facility: Casa Sollievo Della Sofferenza
city: San Sisto
country: Italy
facility: Oncologia Pediatrica,- Ospedale "R. Silvestrini"
city: Torino
country: Italy
facility: Azienda Ospedaliera Universitaria Città Della Salute E Della Scienza Di Torino
city: Trieste
country: Italy
facility: Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
city: Varese
country: Italy
facility: Azienda Socio Sanitaria Territoriale Dei Sette Laghi
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata di Verona
city: Utrecht
country: Netherlands
facility: Princess Maxima Centre for Pediatric Oncology
city: Bergen
country: Norway
facility: Haukeland University Hospital in Bergen
city: Tromsø
country: Norway
facility: University Hospital Northern Norway
city: Trondheim
country: Norway
facility: St Olavs Hospital in Trondheim
city: Białystok
country: Poland
facility: Department of Pediatric Oncology and Hematology, Medical University of Bialystok
city: Bydgoszcz
country: Poland
facility: Department of Pediatric Hematology and Oncology, Nicolaus Copernicus University
city: Chorzów
country: Poland
facility: Department of Pediatric Hematology and Oncology, Center of Pediatrics and Oncology in Chorzów
city: Gdańsk
country: Poland
facility: Department of Pediatrics, Hematology, Oncology and Endocrinology, Medical University of Gdansk
city: Kielce
country: Poland
facility: Department of Pediatric Oncology and Hematology, Center of Pediatrics in Kielce
city: Kraków
country: Poland
facility: Department of Pediatric Oncology/Hematology, Institute of Pediatrics, Medical College Jagiellonian University
city: Lublin
country: Poland
facility: Department of Pediatric Hematology, Oncology and Transplantology, Medical University of Lublin
city: Olsztyn
country: Poland
facility: Department of Pediatric Oncology and Hematology, Provincial Specialist Children's Hospital
city: Poznań
country: Poland
facility: Department of Pediatric Oncology, Hematology and Transplantology, Poznan University of Medical Sciences
city: Rzeszów
country: Poland
facility: Department of Paediatric Oncology and Haematology, University of Rzeszów, Department of Pediatrics
city: Szczecin
country: Poland
facility: Department of Pediatrics, Children Hematology nad Oncology, Pomeranian Medical University
city: Warsaw
country: Poland
facility: Department of Pediatrics, Hematology and Oncology, Medical University of Warsaw
city: Warsaw
country: Poland
facility: Department of Pediatric Oncology, Children's Memorial Health Institute
city: Wrocław
country: Poland
facility: Department of Bone Marrow Transplantation, Children Oncology and Hematology, Wroclaw Medical University
city: Zabrze
country: Poland
facility: Department of Pediatric Hematology and Oncology, Silesian Medical University in Katowice
city: Łódź
country: Poland
facility: Department of Pediatrics, Oncology, Hematology and Diabetology, Institute of Pediatrics, Medical University of Lodz
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitário de Coimbra
city: Lisboa
country: Portugal
facility: Instituto Português de Oncologia - Francisco Gentil - Libosa
city: Porto
country: Portugal
facility: Instituto Português de Oncologia - Francisco Gentil - Porto
city: Ekaterinburg
country: Russian Federation
facility: Oncological center of regional Children's Hospital
city: Moscow
country: Russian Federation
facility: National Center for Pediatric Hematology, Oncology and Immunology Moscow
city: Banská Bystrica
country: Slovakia
facility: Department of pediatric oncology and hematology, Children´s Faculty Hospital
city: Bratislava
country: Slovakia
facility: Department of pediatric hematology and oncology, National Institute of Children's Diseases
city: Košice
country: Slovakia
facility: Department of pediatric hematology and oncology, Children´s University Hospital
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Almería
country: Spain
facility: Hospital Universitario Torrecárdenas
city: Badajoz
country: Spain
facility: Hospital Materno-Infantil de Badajoz
city: Baracaldo
country: Spain
facility: Hospital Universitario Cruces
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Donostia
country: Spain
facility: Hospital Universitario Donostia
city: Esplugues De Llobregat
country: Spain
facility: Hospital Sant Joan de Déu
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Las Palmas De Gran Canaria
country: Spain
facility: Complejo Hospitalario Universitario Insular Materno Infantil
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Niño Jesús
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Palma De Mallorca
country: Spain
facility: Hospital Universitari Son Espases
city: Pamplona
country: Spain
facility: Hospital Virgen del Camino
city: Pontevedra
country: Spain
facility: Complejo Hospitalario Universitario de Vigo
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital Universitario Nuestra Señora de Candelaria
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Santiago De Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Göteborg
country: Sweden
facility: Barncancercentrum, Drottning Silvias Barn och Ungdomssjukhus, Sahlgrenska Universitetssjukhuset
city: Linköping
country: Sweden
facility: Barnonkologiska enheten, Barn och Ungdomsmedicinska kliniken, Universitetssjukhuset i Linköping
city: Lund
country: Sweden
facility: Barnonkologi, Skåne Universitetssjukhus
city: Stockholm
country: Sweden
facility: Barncanceravdelningen Astrid Lindgrens Barnsjukhus, Nya Karolinska Universitetssjukhuset
city: Umeå
country: Sweden
facility: Barnonkologiska avdelningen, Barn 3, Norrlands Universitetssjukhus
city: Uppsala
country: Sweden
facility: Barnavdelningen för blod- och tumörsjukdomar 95A, Akademiska sjukhuset
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
city: Basel
country: Switzerland
facility: Universitäts-Kinderspital beider Basel (UKBB)
city: Bellinzona
country: Switzerland
facility: Ospedale San Giovanni
city: Bern
country: Switzerland
facility: Inselspital Bern, University of Bern
city: Geneva
country: Switzerland
facility: HUG Hôpitaux Universitaires de Genève
city: Lausanne
country: Switzerland
facility: CHUV - Centre Hospitalier Universitaire Vaudois
city: Luzern
country: Switzerland
facility: Luzerner Kantonspital - Kinderspital Luzern
city: Sankt Gallen
country: Switzerland
facility: Ostschweizer Kinderspital
city: Zürich
country: Switzerland
facility: Universitäts-Kinderspital Zürich
Study officials:
affiliation: University Hospital Muenster, Klinik für Kinder- und Jugendmedizin - Pädiatrische Hämatologie und Onkologie
name: Birgit Burkhardt, Prof. Dr. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.