AzTrials
AzTrials

Lymphoblastic Lymphoma, ChildhoodPhase 3LBL 2018NCT04043494

International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma

A Phase 3 study testing Cyclophosphamide, Cytarabine and Dexamethasone in people with Lymphoblastic Lymphoma, Childhood, run by University Hospital Muenster at 228 sites in 21 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Lymphoblastic Lymphoma, Childhood
What is being tested?
Cyclophosphamide, Cytarabine and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
683 participants
Where
228 sitesin 21 countries
Study dates
23 Aug 2019to 22 Apr 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

228 sites in 21 countries. Contact the study team or a site near you to ask about taking part.

Birgit Burkhardt, Prof. Dr. Dr. contact

+49 251 83 55696

LBL2018@ukmuenster.de

228 sites in 21 countries

Germany55 sites, 54 recruiting

  • Universitätsklinikum Aachen .Klinik für Kinder - und Jugendmedizin Hämatologie / Onkologie

    Aachen, 52057

    Recruiting

  • Klinikum Augsburg ,Schwäbisches Kinderkrebszentrum. I. Klinik für Kinder und Jugendliche Hämatologie / Onkologie

    Augsburg, 86156

    Recruiting

  • HELIOS Klinikum Berlin-Buch, Kinderklinik, Pädiatrische Hämatologie und Onkologie

    Berlin, 13125

    Recruiting

  • Charité Campus Virchow-Klinikum, Zentrum für Kinder- und Jugendmedizin- Abt. Hämatologie / Onkologie

    Berlin, 13353

    Recruiting

  • Evangelisches Krankenhaus Bielefeld GmbH, Klinik für Kinder- und Jugendmedizin, Hämatologie und Onkologie

    Bielefeld, 33617

    Recruiting

  • Zentrum für Kinderheilkunde der Universität Bonn, Abt. Päd. Hämatologie / Onkologie

    Bonn, 55113

    Recruiting

  • Städtisches Klinikum Braunschweig gGmbH, Zentrum für Kinder- und Jugendmedizin

    Braunschweig, 38126

    Recruiting

  • Klinikum Bremen-Mitte gGmbH, Prof.-Hess-Kinderklinik,Pädiatrische Onkologie und Hämatologie

    Bremen, 28177

    Recruiting

  • Klinikum Chemnitz gGmbH, Klinik für Kinder- und Jugendmedizin, Päd. Hämatologie und Onkologie

    Chemnitz, 09116

    Not yet recruiting

  • Klinikum der Universität zu Köln, Klinik für Kinder- und Jugendmedizin, Abt. Kinderonkologie und -hämatologie

    Cologne, 50924

    Not yet recruiting

  • Carl-Thiem-Klinikum, Kinderklinik, Station 5e

    Cottbus, 03048

    Recruiting

  • Vestische Kinderklinik, Universität Witten / Herdecke

    Datteln, 45711

    Recruiting

  • Klinikum Dortmund gGmbH, Klinik für Kinder- und Jugendmedizin, Station K1, Abt. Päd. Onkologie / Hämatologie

    Dortmund, 44137

    Recruiting

  • Universitätsklinik Carl Gustav Carus der TU Dresden, Klinik für Kinder- und Jugendmedizin

    Dresden, 01307

    Recruiting

  • Universitätsklinikum Düsseldorf, Zentrum für Kinder- und Jugendmedizin, Klinik für Päd. Hämatologie und Onkologie

    Düsseldorf, 40225

    Recruiting

  • HELIOS Klinikum Erfurt GmbH, Klinik für Kinder- und Jugendmedizin, Päd. Onkologie / Hämatologie

    Erfurt, 99089

    Recruiting

  • Universitätsklinikum Erlangen, Klinik für Kinder- und Jugendmedizin, Pädiatrische Onkologie / Hämatologie

    Erlangen, 91054

    Recruiting

  • Universitätsklinikum Essen, Zentrum für Kinder- und Jugendmedizin, Hämatologie / Onkologie

    Essen, 45122

    Recruiting

  • Universitätsklinikum Frankfurt, Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie und Onkologie

    Frankfurt, 60590

    Recruiting

  • Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin, Klinik IV: Päd. Hämatologie und Onkologie

    Freiburg im Breisgau, 79106

    Recruiting

  • Universitätsklinikum Gießen und Marburg, Standort Gießen, Zentrum für Kinderhämatologie und -onkologie

    Giessen, 35385

    Recruiting

  • Georg-August-Universität Universitäts-Kinderklinik, Pädiatrie I

    Göttingen, 37075

    Recruiting

  • Universitätsklinikum Greifswald KdöR, Klinik und Poliklinik für Kinder- und Jugendmedizin, Abt. Pädiatrische Onkologie und Hämatologie

    Greifswald, 17475

    Recruiting

  • Universitätsklinikum Halle (Saale), Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie / Onkologie

    Halle, 06120

    Recruiting

  • Universitätsklinikum Hamburg Eppendorf, Zentrum für Kinder- und Jugendmedizin, Abt. Pädiatrische Hämatologie und Onkologie

    Hamburg, 20246

    Recruiting

  • Medizinische Hochschule Hannover, Kinderheilkunde, Päd. Hämatologie / Onkologie

    Hanover, 30625

    Recruiting

  • Universitäts-Kinderklinik Heidelberg, Abt. Hämatologie / Onkologie

    Heidelberg, 69120

    Recruiting

  • Gemeinschaftskrankenhaus Herdecke, Kinder- und Jugendmedizin, Päd. Hämatologie / Onkologie

    Herdecke, 58313

    Recruiting

  • Universitätskliniken für Kinder- und Jugendmedizin, Päd. Hämatologie und Onkologie, Geb. 9

    Homburg, 66421

    Recruiting

  • Universitätsklinikum Jena, Klinik für Kinder- und Jugendmedizin

    Jena, 07745

    Recruiting

  • Städtisches Klinikum Karlsruhe gGmbH, Kinderklinik, Station S 24

    Karlsruhe, 76133

    Recruiting

  • Klinikum Kassel Gesundheit Nordhessen Holding AG, Klinik für pädiatrische Hämatologie und Onkologie

    Kassel, 34125

    Recruiting

  • Universitätsklinikum Schleswig Holstein Campus Kiel, Klinik für Allgemeine Pädiatrie, Päd. Onkologie / Hämatologie

    Kiel, 24105

    Recruiting

  • Gemeinschaftsklinikum Mittelrhein Kemperhof, Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie und Onkologie

    Koblenz, 56073

    Recruiting

  • HELIOS Klinikum Krefeld, Zentrum für Kinder- und Jugendmedizin, Päd. Hämatologie/Onkologie

    Krefeld, 47805

    Recruiting

  • Universitätsklinikum Leipzig, Klinik für Kinder und Jugendliche, Abt. Päd. Hämatologie / Onkologie

    Leipzig, 04103

    Recruiting

  • Universitätsklinikum Schleswig Holstein Campus Lübeck, Klinik für Kinder- und Jugendmedizin, Hämatologie und Onkologie

    Lübeck, 23538

    Recruiting

  • Universitätsklinikum Magdeburg A. ö. R., Kinderklinik, Päd. Hämatologie / Onkologie

    Magdeburg, 39120

    Recruiting

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Zentrum für Kinder- und Jugendmedizin, Pädiatrische Hämatologie / Onkologie

    Mainz, 55101

    Recruiting

  • Klinikum Mannheim gGmbH, Universitäts-Kinderklinik, Päd. Onkologie /Hämatologie

    Manheim, 68167

    Recruiting

  • Johannes Wesling Klinikum Minden, Klinik für Kinder- und Jugendmedizin, Päd. Hämatologie / Onkologie, Station E 22

    Minden, 32429

    Recruiting

  • Klinikum der LMU, Dr. von Haunersches Kinderspital, Pädiatrische Hämatologie / Onkologie

    München, 80337

    Recruiting

  • Klinikum Schwabing, Kinderklinik der TU Päd. Hämatologie / Onkologie, Station 24d

    München, 80804

    Recruiting

  • Universitätsklinikum Münster, Klinik für Kinder- und Jugendmedizin, Abt. Pädiatrische Hämatologie und Onkologie

    Münster, 48149

    Recruiting

  • Diakonie Neuendettelsau, Kliniken Hallerwiese / Cnopf'sche Kinderklinik, Pädiatrische Hämatologie /Onkologie

    Nuremberg, 90419

    Recruiting

  • Klinikum Oldenburg AöR, Zentrum für Kinder- und Jugendmedizin, Abt. Hämatologie / Onkologie

    Oldenburg, 26133

    Recruiting

  • Universitätsklinikum Regensburg, Klinik für Kinder- und Jugendmedizin, Abt. Päd. Hämatologie, Onkologie, SZT

    Regensburg, 93053

    Recruiting

  • Universitätsklinikum Rostock, Kinder- und Jugendklinik, Päd. Hämatologie und Onkologie

    Rostock, 18057

    Recruiting

  • Asklepios Klinik St. Augustin GmbH, Kinder- und Jugendmedizin, Kinder-Hämatologie und Onkologie

    Sankt Augustin, 53757

    Recruiting

  • HELIOS Kliniken Schwerin GmbH, Klinik für Kinder- und Jugendmedizin, Station A1

    Schwerin, 19049

    Recruiting

  • Klinikum Stuttgart, Olgahospital Zentrum für Kinder- und Jugendmedizin Pädiatrie 5 (Onkologie, Hämatologie, Immunologie)

    Stuttgart, 70174

    Recruiting

  • Klinikum Mutterhaus der Borromäerinnen gGmbH, Pädiatrische Abteilung

    Trier, 54290

    Withdrawn

  • Universitätsklinik Tübingen, Klinik für Kinderheilkunde und Jugendmedizin, Päd. Hämatologie / Onkologie

    Tübingen, 72076

    Recruiting

  • Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin, Päd. Hämatologie und Onkologie

    Ulm, 89081

    Recruiting

  • Universitätskinderklinik Würzburg, Päd. Onkologie und Hämatologie

    Würzburg, 97080

    Recruiting

Other trials in Germany

Italy33 sites, 27 recruiting

  • Azienda Ospedaliero Universitaria Delle Marche

    Ancona, 60126

    Not yet recruiting

  • University Hospital Consorziale Policlinico

    Bari, 70124

    Recruiting

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, 24127

    Not yet recruiting

  • Azienda Ospedaliero-Universitaria Di Bologna IRCCS

    Bologna, 40138

    Recruiting

  • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

    Brescia, 25123

    Recruiting

  • ARNAS G. Brotzu

    Cagliari, 09121

    Recruiting

  • Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania

    Catania, 95123

    Not yet recruiting

  • University Hospital Of Ferrara

    Cona, 44124

    Not yet recruiting

  • U. O. di Pediatria- Azienda Ospedaliera Annunziata

    Cosenza, 87100

    Withdrawn

  • Dipartimento di Medicina Clinica e Sperimentale Sezione di Pediatria - Università di Ferrara

    Ferrara, 44100

    Withdrawn

  • Azienda Ospedaliera Universitaria Meyer IRCCS

    Florence, 50139

    Recruiting

  • Giannina Gaslini Institute For Scientific Hospitalization And Care

    Genova, 16147

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

    Recruiting

  • Azienda Ospedaliero Universitaria di Modena

    Modena, 41124

    Withdrawn

  • Fondazione IRCCS San Gerardo Dei Tintori

    Monza, 20900

    Recruiting

  • S.C. Ematologia Oncologica- Ospedale "Pausilipon"

    Naples, 80123

    Withdrawn

  • L'Azienda Ospedaliera Di Rilievo Nazionale Santobono-Pausilipon

    Naples, 80129

    Recruiting

  • Azienda Ospedale-Università Padova

    Padova, 35128

    Recruiting

  • ARNAS Civico Di Cristina Benfratelli

    Palermo, 90127

    Not yet recruiting

  • Azienda Ospedaliero-Universitaria di Parma

    Parma, 43126

    Recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

    Recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Perugia, 06129

    Not yet recruiting

  • Azienda Sanitaria Locale Di Pescara

    Pescara, 65124

    Not yet recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126

    Recruiting

  • Azienda Unità Sanitaria della Romagna

    Rimini, 48121

    Recruiting

  • Sezione Ematologia- Dipart. Biotecnico Cellulare ed Ematologia- Università "La Sapienza"

    Roma, 00161

    Withdrawn

  • Ospedale Pediatrico Bambino Gesù

    Roma, 00165

    Not yet recruiting

  • Casa Sollievo Della Sofferenza

    San Giovanni Rotondo, 71013

    Recruiting

  • Oncologia Pediatrica,- Ospedale "R. Silvestrini"

    San Sisto, 06080

    Withdrawn

  • Azienda Ospedaliera Universitaria Città Della Salute E Della Scienza Di Torino

    Torino, 10126

    Recruiting

  • Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo

    Trieste, 34137

    Recruiting

  • Azienda Socio Sanitaria Territoriale Dei Sette Laghi

    Varese, 21100

    Recruiting

  • Azienda Ospedaliera Universitaria Integrata di Verona

    Verona, 37126

    Recruiting

Other trials in Italy

Spain30 sites, 30 recruiting

  • Hospital General Universitario de Alicante

    Alicante, 03010

    Recruiting

  • Hospital Universitario Torrecárdenas

    Almería, 04009

    Recruiting

  • Hospital Materno-Infantil de Badajoz

    Badajoz, 06010

    Recruiting

  • Hospital Universitario Cruces

    Barakaldo, 48903

    Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

    Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

    Recruiting

  • Hospital Universitario Donostia

    Donostia / San Sebastian, 20014

    Recruiting

  • Hospital Sant Joan de Déu

    Esplugues de Llobregat, 08950

    Recruiting

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014

    Recruiting

  • Complejo Hospitalario Universitario Insular Materno Infantil

    Las Palmas de Gran Canaria, 35016

    Recruiting

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

    Recruiting

  • Hospital Infantil Universitario Niño Jesús

    Madrid, 28009

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046

    Recruiting

  • Hospital Regional Universitario de Málaga

    Málaga, 29010

    Recruiting

  • Hospital Clínico Universitario Virgen de la Arrixaca

    Murcia, 30120

    Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo, 33011

    Recruiting

  • Hospital Universitari Son Espases

    Palma de Mallorca, 07120

    Recruiting

  • Hospital Virgen del Camino

    Pamplona, 31008

    Recruiting

  • Complejo Hospitalario Universitario de Vigo

    Pontevedra, 36036

    Recruiting

  • Hospital Universitario Nuestra Señora de Candelaria

    Santa Cruz de Tenerife, 38010

    Recruiting

  • Hospital Universitario Marqués de Valdecilla

    Santander, 390008

    Recruiting

  • Hospital Clínico Universitario de Santiago

    Santiago de Compostela, 15706

    Recruiting

  • Hospital Universitario Virgen Macarena

    Seville, 41009

    Recruiting

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

    Recruiting

  • Hospital Virgen de la Salud

    Toledo, 45004

    Recruiting

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

    Recruiting

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026

    Recruiting

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47003

    Recruiting

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

    Recruiting

Other trials in Spain

France29 sites, 29 recruiting

  • Service d'oncolologie, Hématologie pédiatrique. CHU Amiens, Avenue René Laënnec - SALOUEL

    Amiens, 80054

    Not yet recruiting

  • Pôle Femme Mère Enfant ; Unité d'Hématologie/Oncologie pédiatrique, CHU Angers

    Angers, 49033

    Not yet recruiting

  • Hématologie Oncologie pédiatrique, CHRU Besançon

    Besançon, 25030

    Not yet recruiting

  • Hôpital de Enfants, Unité Onco-Hématologie Pédiatrique, Groupe Hospitalier Pellegrin

    Bordeaux, 33076

    Not yet recruiting

  • Département de Pédiatrie et Génétique Médicale CHRU Morvan

    Brest, 29609

    Not yet recruiting

  • Unité d'hémato-immuno-oncologie pédiatrique. Centre Hospitalier Universitaire niveau 1 - bâtiment FEH

    Caen, 14033

    Not yet recruiting

  • Unité Onco- Hématologie Pédiatrique CHU Estaing 1 place Lucie-Aubrac

    Clermont-Ferrand, 63303

    Not yet recruiting

  • Service Immuno-Hématologie Oncologie Pédiatrique

    Dijon, 21079

    Not yet recruiting

  • Service onco hématologie pédiatrique CHU de Grenoble site Nord - Hôpital Couple enfant

    Grenoble, 38043

    Not yet recruiting

  • Unité d'hématologie pédiatrique CHRU de Lille - Hôpital Jeanne de Flandre

    Lille, 59037

    Not yet recruiting

  • Service d'Hématologie - Oncologie pédiatrique CHU Limoges - Hôpital de la mère et de l'enfant

    Limoges, 87042

    Not yet recruiting

  • Service d'immuno-hématologie pédiatrique et de transplantation de moelle osseuse, CHU de Lyon HCL - GH Est-Institut d'hématologie et d'oncologie pédiatrique IHOP

    Lyon, 69373

    Not yet recruiting

  • Service de Pédiatrie et hématologie pédiatrique, CHU de Marseille - Hôpital de la Timone

    Marseille, 13385

    Not yet recruiting

  • UAM Hématologie et Oncologie Pédiatrique, CHU de Montpellier - Hôpital Arnaud de Villeneuve

    Montpellier, 34295

    Not yet recruiting

  • Service d'hématologie et oncologie pédiatriques, Hôpital enfant-adolescent, CHU NANTES

    Nantes, 44093

    Not yet recruiting

  • Service d'hémato-oncologie pédiatrique CHU NICE - Hôpital l'Archet 2

    Nice, 06200

    Not yet recruiting

  • service d'oncologie pédiatrique, institut Curie

    Paris, 75005

    Not yet recruiting

  • Service Hémato-immuno- oncologie- CHU PARIS Armand Trousseau

    Paris, 75012

    Not yet recruiting

  • Service d' hémato-immunologie CHU Paris - Hôpital Robert Debré

    Paris, 75019

    Not yet recruiting

  • Service Oncologie-Hématologie pédiatrique CHU de Poitiers

    Poitiers, 86000

    Not yet recruiting

  • Service d'Hémato-Oncologie Pédiatrique- American Hospital

    Reims, 51100

    Not yet recruiting

  • Pôle pédiatrie Hémato-cancérologie pédiatrique- CHU RENNES - Hôpital sud

    Rennes, 35203

    Not yet recruiting

  • Service d'Hemato-Oncologie Pediatrique CHU Rouen

    Rouen, 76031

    Not yet recruiting

  • service d'oncologie pédiatrique, hopital Félix Guyon

    Saint-Denis, 97405

    Not yet recruiting

  • Pôle mère enfant-Unité Hématologie - Oncologie pédiatrique - CHU Hôpital NORD

    Saint-Priest-en-Jarez, 42270

    Not yet recruiting

  • Service d'Onco-Hematologie Pediatrique CHU STRASBOURG -Hôpital de Hautepierre

    Strasbourg, 67098

    Not yet recruiting

  • Service Pédiatrie - Hématologie Immunologie Oncologie - CHU Toulouse

    Toulouse, 31059

    Not yet recruiting

  • Service d'hémato-oncologie pédiatrique- CHU de Nancy - Hôpital de Brabois Enfant

    Vandœuvre-lès-Nancy, 54511

    Not yet recruiting

  • Dépt de Pédiatrie Gustave Roussy

    Villejuif, 94805

    Not yet recruiting

Other trials in France

Poland16 sites, 16 recruiting

  • Department of Pediatric Oncology and Hematology, Medical University of Bialystok

    Bialystok, 15-247

    Not yet recruiting

  • Department of Pediatric Hematology and Oncology, Nicolaus Copernicus University

    Bydgoszcz, 85-094

    Not yet recruiting

  • Department of Pediatric Hematology and Oncology, Center of Pediatrics and Oncology in Chorzów

    Chorzów, 41-500

    Not yet recruiting

  • Department of Pediatrics, Hematology, Oncology and Endocrinology, Medical University of Gdansk

    Gdansk, 20-211

    Not yet recruiting

  • Department of Pediatric Oncology and Hematology, Center of Pediatrics in Kielce

    Kielce, 25-736

    Not yet recruiting

  • Department of Pediatric Oncology/Hematology, Institute of Pediatrics, Medical College Jagiellonian University

    Krakow, 30-663

    Not yet recruiting

  • Department of Pediatrics, Oncology, Hematology and Diabetology, Institute of Pediatrics, Medical University of Lodz

    Lodz, 91-138

    Not yet recruiting

  • Department of Pediatric Hematology, Oncology and Transplantology, Medical University of Lublin

    Lublin, 20-093

    Not yet recruiting

  • Department of Pediatric Oncology and Hematology, Provincial Specialist Children's Hospital

    Olsztyn, 10-561

    Not yet recruiting

  • Department of Pediatric Oncology, Hematology and Transplantology, Poznan University of Medical Sciences

    Poznan, 60-572

    Not yet recruiting

  • Department of Paediatric Oncology and Haematology, University of Rzeszów, Department of Pediatrics

    Rzeszów, 35-301

    Not yet recruiting

  • Department of Pediatrics, Children Hematology nad Oncology, Pomeranian Medical University

    Szczecin, 71-242

    Not yet recruiting

  • Department of Pediatrics, Hematology and Oncology, Medical University of Warsaw

    Warsaw, 00-576

    Not yet recruiting

  • Department of Pediatric Oncology, Children's Memorial Health Institute

    Warsaw, 04-576

    Not yet recruiting

  • Department of Bone Marrow Transplantation, Children Oncology and Hematology, Wroclaw Medical University

    Wroclaw, 50-556

    Not yet recruiting

  • Department of Pediatric Hematology and Oncology, Silesian Medical University in Katowice

    Zabrze, 41-800

    Not yet recruiting

Other trials in Poland

Switzerland9 sites, 9 recruiting

  • Kantonsspital Aarau

    Aarau, 5001

    Not yet recruiting

  • Universitäts-Kinderspital beider Basel (UKBB)

    Basel, 4056

    Not yet recruiting

  • Ospedale San Giovanni

    Bellinzona, 6500

    Not yet recruiting

  • Inselspital Bern, University of Bern

    Bern, 3010

    Not yet recruiting

  • HUG Hôpitaux Universitaires de Genève

    Geneva, 1211

    Not yet recruiting

  • CHUV - Centre Hospitalier Universitaire Vaudois

    Lausanne, 1011

    Not yet recruiting

  • Luzerner Kantonspital - Kinderspital Luzern

    Lucerne, 6000

    Not yet recruiting

  • Ostschweizer Kinderspital

    Sankt Gallen, 9006

    Not yet recruiting

  • Universitäts-Kinderspital Zürich

    Zurich, 8032

    Not yet recruiting

Other trials in Switzerland

Belgium8 sites, 8 recruiting

  • Hôpital Universitaire des Enfants Reine Fabiola (ULB), Pédiatrie hémato-oncologie

    Brussels, 1020

    Recruiting

  • University Hospital Brussels, Pediatrische oncologie

    Brussels, 1090

    Recruiting

  • Cliniques Universitaires Saint-Luc (UCL), Hématologie et oncologie pédiatrique

    Brussels, 1200

    Recruiting

  • UZ Antwerpen Kinderhemato-oncologie

    Edegem, 2650

    Recruiting

  • University Hospital Gent Pediatrische hemato-oncologie

    Ghent, 9000

    Recruiting

  • University Hospitals Leuven, Kinderhemato-oncologie

    Leuven, 3000

    Recruiting

  • CHR Citadelle Hémato - oncologie pédiatrique

    Liège, 4000

    Recruiting

  • CHR Citadelle Hémato - oncologie pédiatrique

    Montegnée, 4000

    Recruiting

Other trials in Belgium

Hungary6 sites, 6 recruiting

  • 2nd Dep. of Pediatrics, Semmelweis Univ

    Budapest

    Not yet recruiting

  • Heim Pal Children Hospital

    Budapest

    Not yet recruiting

  • Dep. of Pediatrics, Univ. of Debrecen

    Debrecen

    Not yet recruiting

  • Children's Treating Center, Miskolc

    Miskolc

    Not yet recruiting

  • Dep. of Pediatrics, University of Pecs

    Pécs

    Not yet recruiting

  • Dep. of Pediatrics, Univ. of Szeged

    Szeged

    Not yet recruiting

Other trials in Hungary

Israel6 sites, 6 recruiting

  • Children's Hospital at Soroka Medical Center

    Beersheba

    Not yet recruiting

  • Ruth Rappaport Children's Hospital, Rambam Medical Center

    Haifa

    Not yet recruiting

  • Children's Hospital at Hadassah, Ein Kerem Medical Center

    Jerusalem

    Not yet recruiting

  • Schneider Children's hospital, Rabin Medical Center

    Petah Tikva

    Not yet recruiting

  • Edmond and Lily Safra Children's Hospital, Sheba Medical Center

    Ramat Gan

    Not yet recruiting

  • Dana Children's Hospital, Tel-Aviv Sourasky Medical Center

    Tel Aviv

    Not yet recruiting

Other trials in Israel

Sweden6 sites, 6 recruiting

  • Barncancercentrum, Drottning Silvias Barn och Ungdomssjukhus, Sahlgrenska Universitetssjukhuset

    Gothenburg, 416 85

    Recruiting

  • Barnonkologiska enheten, Barn och Ungdomsmedicinska kliniken, Universitetssjukhuset i Linköping

    Linköping, 581 85

    Recruiting

  • Barnonkologi, Skåne Universitetssjukhus

    Lund, 221 85

    Recruiting

  • Barncanceravdelningen Astrid Lindgrens Barnsjukhus, Nya Karolinska Universitetssjukhuset

    Stockholm, 171 76

    Recruiting

  • Barnonkologiska avdelningen, Barn 3, Norrlands Universitetssjukhus

    Umeå, 901 85

    Recruiting

  • Barnavdelningen för blod- och tumörsjukdomar 95A, Akademiska sjukhuset

    Uppsala, 752 39

    Recruiting

Other trials in Sweden

Austria5 sites, 5 recruiting

  • Univ.Klinik für Kinder- und Jugendheilkunde Graz, Klin. Abteilung für pädiatrische Hämato-Onkologie

    Graz, 8036

    Recruiting

  • Univ.Klinik für Kinder- und Jugendheilkunde Innsbruck, Universitätsklinik für Pädiatrie I

    Innsbruck, 6020

    Recruiting

  • Kepler Universitätsklinikum, Med Campus IV / Onkologie

    Linz, 4020

    Recruiting

  • LKH Salzburg, Universitätsklinik für Kinder- und Jugendheilkunde, Kinderonkologie

    Salzburg, 5020

    Recruiting

  • St. Anna Kinderspital

    Vienna, 1090

    Recruiting

Other trials in Austria

Finland5 sites, 5 recruiting

  • Helsinki University Hospital, Department of Pediatric Hematology and Oncology

    Helsinki, 00029 HUS

    Recruiting

  • Kuopio University Hospital, Department of Pediatric Hematology and Oncology

    Kuopio, 70029 KYS

    Recruiting

  • University Hospital of Oulu, Paediatric Haematology and Oncology

    Oulu, 90029 OYS

    Recruiting

  • Tampere University Hospital, Paediatric Haematology and Oncology

    Tampere, 33521 Tampere

    Recruiting

  • Turku University Hospital, Paediatric and Adolescent Haematology and Oncology

    Turku, 20521 Turku

    Recruiting

Other trials in Finland

Denmark4 sites, 4 recruiting

  • University Hospital Aalborg, Nord, Department of Pediatrics

    Aalborg, 9000

    Recruiting

  • Aarhus University Hospital, Department of Pediatrics

    Aarhus, 8200

    Recruiting

  • Børneonkologisk afsnit 5054, BørneUngeKlinikken, Juliane Marie Centret, Rigshospitalet

    Copenhagen, 2100 Ø

    Recruiting

  • H.C. Andersens Children Hospital, Odense University Hospital

    Odense, 5000

    Recruiting

Other trials in Denmark

Norway3 sites, 3 recruiting

  • Haukeland University Hospital in Bergen

    Bergen

    Recruiting

  • University Hospital Northern Norway

    Tromsø

    Recruiting

  • St Olavs Hospital in Trondheim

    Trondheim

    Recruiting

Other trials in Norway

Portugal3 sites, 3 recruiting

  • Centro Hospitalar e Universitário de Coimbra

    Coimbra, 3000-602

    Not yet recruiting

  • Instituto Português de Oncologia - Francisco Gentil - Libosa

    Lisbon, 1099-023

    Not yet recruiting

  • Instituto Português de Oncologia - Francisco Gentil - Porto

    Porto, 4200-072

    Not yet recruiting

Other trials in Portugal

Slovakia3 sites, 3 recruiting

  • Department of pediatric oncology and hematology, Children´s Faculty Hospital

    Banská Bystrica, 974 09

    Not yet recruiting

  • Department of pediatric hematology and oncology, National Institute of Children's Diseases

    Bratislava, 833 40

    Not yet recruiting

  • Department of pediatric hematology and oncology, Children´s University Hospital

    Košice, 04011

    Not yet recruiting

Other trials in Slovakia

Czechia2 sites, 2 recruiting

  • Dept. of Pediatric Oncology, University Hospital Brno and Faculty of Medicine, Masaryk University Cernopolni

    Brno, 662 63

    Recruiting

  • Dept. of Pediatric Hematology and Oncology. University Hospital Motol and 2nd Medical School, Charles University

    Prague, 160 06

    Recruiting

Other trials in Czechia

Russia2 sites, 2 recruiting

  • National Center for Pediatric Hematology, Oncology and Immunology Moscow

    Moscow, 117198

    Recruiting

  • Oncological center of regional Children's Hospital

    Yekaterinburg

    Recruiting

Other trials in Russia

China1 site, 1 recruiting

  • Hong Kong Children's Hospital

    Hong Kong

    Recruiting

Other trials in China

Ireland1 site, 1 recruiting

  • Our Lady's Children's Hospital Crumlin

    Dublin

    Not yet recruiting

Other trials in Ireland

Netherlands1 site, 1 recruiting

  • Princess Maxima Centre for Pediatric Oncology

    Utrecht, 3584CS

    Not yet recruiting

Other trials in Netherlands

About this study

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

Primary objectives:

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

Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CyclophosphamideDrug

    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)

  • CytarabineDrug

    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)

  • DexamethasoneDrug

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

  • DaunorubicinDrug

    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)

  • DoxorubicinDrug

    Part of standard chemotherapy

  • IfosfamideDrug

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

  • 6-MercaptopurineDrug

    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)

  • MethotrexateDrug

    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)

  • PEG asparaginaseDrug

    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)

  • PrednisoneDrug

    Part of standard chemotherapy

  • PrednisoloneDrug

    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

  • ThioguanineDrug

    Part of standard chemotherapy

  • VincristineDrug

    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)

  • VindesineDrug

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

Study groups in NCT04043494
Study groupRoleWhat they receive
SR I/II: R1 into protocol Ia-PredOther1. cytoreductive prephase with prednisone 2. standard induction phase (protocol Ia-prednisone) 3. consolidation phase (protocol Ib) 4. non-HR extra-compartment phase (protocol M) 5. maintenance therapy
Receives: Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Daunorubicin; Drug: 6-Mercaptopurine; Drug: Methotrexate; Drug: PEG asparaginase; Drug: Prednisone; Drug: Prednisolone; Drug: Vincristine
SR I/II: R1 into protocol Ia-DexaExperimental1. cytoreductive prephase with prednisone 2. experimental induction phase (protocol Ia-dexamethasone) 3. consolidation phase (protocol Ib) 4. non-HR extra-compartment Phase (protocol M) 5. maintenance therapy
Receives: Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dexamethasone; Drug: Daunorubicin; Drug: 6-Mercaptopurine; Drug: Methotrexate; Drug: PEG asparaginase; Drug: Prednisone; Drug: Prednisolone; Drug: Vincristine
SR: R1 into protocol Ia-PredOther1. cytoreductive prephase with prednisone 2. standard induction phase (protocol Ia-prednisone) 3. consolidation phase (protocol Ib) 4. non-HR extra-compartment phase (protocol M) 5. reintensification phase (protocol II) 6. maintenance therapy
Receives: Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dexamethasone; Drug: Daunorubicin; Drug: Doxorubicin; Drug: 6-Mercaptopurine; Drug: Methotrexate; Drug: PEG asparaginase; Drug: Prednisone; Drug: Prednisolone; Drug: Thioguanine; Drug: Vincristine
SR: R1 into protocol Ia-DexaExperimental1. cytoreductive prephase with prednisone 2. experimental induction phase (protocol Ia-dexamethasone) 3. consolidation phase (protocol Ib) 4. non-HR extra-compartment phase (protocol M) 5. reintensification phase (protocol II) 6. maintenance therapy
Receives: Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dexamethasone; Drug: Daunorubicin; Drug: Doxorubicin; Drug: 6-Mercaptopurine; Drug: Methotrexate; Drug: PEG asparaginase; Drug: Prednisone; Drug: Prednisolone; Drug: Thioguanine; Drug: Vincristine
HR: R1 into "Pred" and R2 into non-HR extra-compartment phaseOther1. cytoreductive prephase with prednisone 2. standard induction phase (protocol Ia-prednisone) 3. consolidation phase (protocol Ib) 4. non-HR extra-compartment phase (protocol M) 5. reintensification phase (protocol II) 6. maintenance therapy
Receives: Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dexamethasone; Drug: Daunorubicin; Drug: Doxorubicin; Drug: 6-Mercaptopurine; Drug: Methotrexate; Drug: PEG asparaginase; Drug: Prednisone; Drug: Prednisolone; Drug: Thioguanine; Drug: Vincristine
HR: R1 into "Dexa" and R2 into non-HR extra-compartment phaseExperimental1. cytoreductive prephase with prednisone 2. experimental induction phase (protocol Ia-dexamethasone) 3. consolidation phase (protocol Ib) 4. non-HR extra-compartment phase (protocol M) 5. reintensification phase (protocol II) 6. maintenance therapy
Receives: Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dexamethasone; Drug: Daunorubicin; Drug: Doxorubicin; Drug: 6-Mercaptopurine; Drug: Methotrexate; Drug: PEG asparaginase; Drug: Prednisone; Drug: Prednisolone; Drug: Thioguanine; Drug: Vincristine
HR: R1 into "Pred" and R2 into HR extra-compartment phaseExperimental1. cytoreductive prephase with prednisone 2. standard induction phase (protocol Ia-prednisone) 3. consolidation phase (protocol Ib*) 4. HR extra-compartment phase (intensified protocol M) 5. reintensification phase (protocol II) 6. maintenance therapy
Receives: Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dexamethasone; Drug: Daunorubicin; Drug: Doxorubicin; Drug: Ifosfamide; Drug: 6-Mercaptopurine; Drug: Methotrexate; Drug: PEG asparaginase; Drug: Prednisone; Drug: Prednisolone; Drug: Thioguanine; Drug: Vincristine; Drug: Vindesine
HR: R1 into "Dexa" and R2 into HR extra-compartment phaseExperimental1. cytoreductive prephase with prednisone 2. experimental induction phase (protocol Ia-dexamethasone) 3. consolidation phase (protocol Ib*) 4. HR extra-compartment phase (intensified protocol M) 5. reintensification phase (protocol II) 6. maintenance therapy
Receives: Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dexamethasone; Drug: Daunorubicin; Drug: Doxorubicin; Drug: Ifosfamide; Drug: 6-Mercaptopurine; Drug: Methotrexate; Drug: PEG asparaginase; Drug: Prednisone; Drug: Prednisolone; Drug: Thioguanine; Drug: Vincristine; Drug: Vindesine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: through study completion, maximal 7.25 years

  2. 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.

    Measured: through study completion, maximal 7.25 years

Secondary outcomes (7)

  1. 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

    Measured: through study completion, maximal 7.25 years

  2. Frequency of treatment-related toxicity overall and in specific protocol elements, randomized arms and during follow up

    Measured: through study completion, maximal 7.25 years

  3. Frequency of treatment-related mortality overall and in specific protocol elements, randomized arms and during follow up

    Measured: through study completion, maximal 7.25 years

  4. Frequency of adverse events of interest and severe adverse events overall

    Measured: through study completion, maximal 7.25 years

  5. Rate of evaluable patients for risk group stratification

    Measured: during recruitment

  6. Cumulative incidence of relapses in association with molecular markers

    Measured: through study completion, maximal 7.25 years

  7. Cumulative incidence of relapses in association with minimal residual disease results

    Measured: through study completion, maximal 7.25 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2019
  2. Study start23 Aug 2019
  3. Primary completion22 Apr 2030 (estimated)
  4. Study completion22 Apr 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
683 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04043494
Sponsor's protocol ID
UKM17_0023
Other IDs
2017-001691-39, 2017
Acronym
LBL 2018
Status last verified
Apr 2026
First submitted
15 Jul 2019
Last updated
6 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

    PubMed 33152759

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cyclophosphamide, Cytarabine and Dexamethasone in people with Lymphoblastic Lymphoma, Childhood, run by University Hospital Muenster at 228 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 228 sites in Germany, Italy, Spain, France, Poland and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Birgit Burkhardt, Prof. Dr. Dr. (+49 251 83 55696, LBL2018@ukmuenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative incidence of relapse with involvement of the CNS (CNS-relapse, pCICR) (time frame: through study completion, maximal 7.25 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04043494, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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