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JOURNAL ONKOLOGIE – STUDIE
LBL 2018

International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma

Rekrutierend

NCT-Nummer:
NCT04043494

Studienbeginn:
August 2019

Letztes Update:
30.09.2020

Wirkstoff:
Cyclophosphamide, Cytarabine, Dexamethasone, Daunorubicin, Doxorubicin, ifosfamide, 6-mercaptopurine, Methotrexate, PEG asparaginase, Prednisone, prednisolone, Thioguanine, Vincristine, Vindesine

Indikation (Clinical Trials):
Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Non-Hodgkin

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
Phase 3

Sponsor:
University Hospital Muenster

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

Studienleiter

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

Kontakt

Studienlocations
(3 von 223)

Universitätsklinikum Aachen .Klinik für Kinder - und Jugendmedizin Hämatologie / Onkologie
52057 Aachen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Klinikum Augsburg ,Schwäbisches Kinderkrebszentrum. I. Klinik für Kinder und Jugendliche Hämatologie / Onkologie
86156 Augsburg
(Bayern)
GermanyRekrutierend» Google-Maps
HELIOS Klinikum Berlin-Buch, Kinderklinik, Pädiatrische Hämatologie und Onkologie
13125 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Charité Campus Virchow-Klinikum, Zentrum für Kinder- und Jugendmedizin- Abt. Hämatologie / Onkologie
13353 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Evangelisches Krankenhaus Bielefeld GmbH, Klinik für Kinder- und Jugendmedizin, Hämatologie und Onkologie
33617 Bielefeld
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Zentrum für Kinderheilkunde der Universität Bonn, Abt. Päd. Hämatologie / Onkologie
55113 Bonn
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Städtisches Klinikum Braunschweig gGmbH, Klinik für Kinder- und Jugendmedizin, Station K5 / Päd. Hämato- und Onkologie
38118 Braunschweig
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Klinikum Bremen-Mitte gGmbH, Prof.-Hess-Kinderklinik,Pädiatrische Onkologie und Hämatologie
28177 Bremen
(Bremen)
GermanyRekrutierend» Google-Maps
Klinikum Chemnitz gGmbH, Klinik für Kinder- und Jugendmedizin, Päd. Hämatologie und Onkologie
09116 Chemnitz
(Sachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Carl-Thiem-Klinikum, Kinderklinik, Station 5e
03048 Cottbus
(Brandenburg)
GermanyRekrutierend» Google-Maps
Vestische Kinderklinik, Universität Witten / Herdecke
45711 Datteln
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Klinikum Dortmund gGmbH, Klinik für Kinder- und Jugendmedizin, Station K1, Abt. Päd. Onkologie / Hämatologie
44137 Dortmund
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Universitätsklinik Carl Gustav Carus der TU Dresden, Klinik für Kinder- und Jugendmedizin
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Universitätsklinikum Düsseldorf, Zentrum für Kinder- und Jugendmedizin, Klinik für Päd. Hämatologie und Onkologie
40225 Düsseldorf
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
HELIOS Klinikum Erfurt GmbH, Klinik für Kinder- und Jugendmedizin, Päd. Onkologie / Hämatologie
99089 Erfurt
(Thüringen)
GermanyRekrutierend» Google-Maps
Universitätsklinikum Erlangen, Klinik für Kinder- und Jugendmedizin, Pädiatrische Onkologie / Hämatologie
91054 Erlangen
(Bayern)
GermanyRekrutierend» Google-Maps
Universitätsklinikum Essen, Zentrum für Kinder- und Jugendmedizin, Hämatologie / Onkologie
45122 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Universitätsklinikum Frankfurt, Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie und Onkologie
60590 Frankfurt
(Hessen)
GermanyRekrutierend» Google-Maps
Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin, Klinik IV: Päd. Hämatologie und Onkologie
79106 Freiburg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Universitätsklinikum Gießen und Marburg, Standort Gießen, Zentrum für Kinderhämatologie und -onkologie
35385 Gießen
(Hessen)
GermanyRekrutierend» Google-Maps
Universitätsklinikum Greifswald KdöR, Klinik und Poliklinik für Kinder- und Jugendmedizin, Abt. Pädiatrische Onkologie und Hämatologie
17475 Greifswald
(Mecklenburg-Vorpommern)
GermanyRekrutierend» Google-Maps
Georg-August-Universität Universitäts-Kinderklinik, Pädiatrie I
37075 Göttingen
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Universitätsklinikum Halle (Saale), Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie / Onkologie
06120 Halle
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
Universitätsklinikum Hamburg Eppendorf, Zentrum für Kinder- und Jugendmedizin, Abt. Pädiatrische Hämatologie und Onkologie
20246 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Medizinische Hochschule Hannover, Kinderheilkunde, Päd. Hämatologie / Onkologie
30625 Hannover
(Niedersachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Universitäts-Kinderklinik Heidelberg, Abt. Hämatologie / Onkologie
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Gemeinschaftskrankenhaus Herdecke, Kinder- und Jugendmedizin, Päd. Hämatologie / Onkologie
58313 Herdecke
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Universitätskliniken für Kinder- und Jugendmedizin, Päd. Hämatologie und Onkologie, Geb. 9
66421 Homburg
(Saarland)
GermanyRekrutierend» Google-Maps
Universitätsklinikum Jena, Klinik für Kinder- und Jugendmedizin
07745 Jena
(Thüringen)
GermanyRekrutierend» Google-Maps
Städtisches Klinikum Karlsruhe gGmbH, Kinderklinik, Station S 24
76133 Karlsruhe
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Klinikum Kassel Gesundheit Nordhessen Holding AG, Klinik für pädiatrische Hämatologie und Onkologie
34125 Kassel
(Hessen)
GermanyRekrutierend» Google-Maps
Universitätsklinikum Schleswig Holstein Campus Kiel, Klinik für Allgemeine Pädiatrie, Päd. Onkologie / Hämatologie
24105 Kiel
(Schleswig-Holstein)
GermanyRekrutierend» Google-Maps
Gemeinschaftsklinikum Mittelrhein Kemperhof, Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie und Onkologie
56073 Koblenz
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
HELIOS Klinikum Krefeld, Zentrum für Kinder- und Jugendmedizin, Päd. Hämatologie/Onkologie
47805 Krefeld
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Klinikum der Universität zu Köln, Klinik für Kinder- und Jugendmedizin, Abt. Kinderonkologie und -hämatologie
50924 Köln
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Universitätsklinikum Leipzig, Klinik für Kinder und Jugendliche, Abt. Päd. Hämatologie / Onkologie
04103 Leipzig
(Sachsen)
GermanyRekrutierend» Google-Maps
Universitätsklinikum Schleswig Holstein Campus Lübeck, Klinik für Kinder- und Jugendmedizin, Hämatologie und Onkologie
23538 Lübeck
(Schleswig-Holstein)
GermanyRekrutierend» Google-Maps
Universitätsklinikum Magdeburg A. ö. R., Kinderklinik, Päd. Hämatologie / Onkologie
39120 Magdeburg
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Zentrum für Kinder- und Jugendmedizin, Pädiatrische Hämatologie / Onkologie
55101 Mainz
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
Klinikum Mannheim gGmbH, Universitäts-Kinderklinik, Päd. Onkologie /Hämatologie
68167 Manheim
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Johannes Wesling Klinikum Minden, Klinik für Kinder- und Jugendmedizin, Päd. Hämatologie / Onkologie, Station E 22
32429 Minden
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Klinikum der LMU, Dr. von Haunersches Kinderspital, Pädiatrische Hämatologie / Onkologie
80337 München
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Klinikum Schwabing, Kinderklinik der TU Päd. Hämatologie / Onkologie, Station 24d
80804 München
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Universitätsklinikum Münster, Klinik für Kinder- und Jugendmedizin, Abt. Pädiatrische Hämatologie und Onkologie
48149 Münster
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Diakonie Neuendettelsau, Kliniken Hallerwiese / Cnopf'sche Kinderklinik, Pädiatrische Hämatologie /Onkologie
90419 Nürnberg
(Bayern)
GermanyRekrutierend» Google-Maps
Klinikum Oldenburg AöR, Zentrum für Kinder- und Jugendmedizin, Abt. Hämatologie / Onkologie
26133 Oldenburg
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Universitätsklinikum Regensburg, Klinik für Kinder- und Jugendmedizin, Abt. Päd. Hämatologie, Onkologie, SZT
93053 Regensburg
(Bayern)
GermanyRekrutierend» Google-Maps
Universitätsklinikum Rostock, Kinder- und Jugendklinik, Päd. Hämatologie und Onkologie
18057 Rostock
(Mecklenburg-Vorpommern)
GermanyNoch nicht rekrutierend» Google-Maps
Asklepios Klinik St. Augustin GmbH, Kinder- und Jugendmedizin, Kinder-Hämatologie und Onkologie
53757 Sankt Augustin
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
HELIOS Kliniken Schwerin GmbH, Klinik für Kinder- und Jugendmedizin, Station A1
19049 Schwerin
(Mecklenburg-Vorpommern)
GermanyRekrutierend» Google-Maps
Klinikum Stuttgart, Olgahospital Zentrum für Kinder- und Jugendmedizin Pädiatrie 5 (Onkologie, Hämatologie, Immunologie)
70174 Stuttgart
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Klinikum Mutterhaus der Borromäerinnen gGmbH, Pädiatrische Abteilung
54290 Trier
(Rheinland-Pfalz)
GermanyZurückgezogen» Google-Maps
Universitätsklinik Tübingen, Klinik für Kinderheilkunde und Jugendmedizin, Päd. Hämatologie / Onkologie
72076 Tübingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin, Päd. Hämatologie und Onkologie
89081 Ulm
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Universitätskinderklinik Würzburg, Päd. Onkologie und Hämatologie
97080 Würzburg
(Bayern)
GermanyRekrutierend» Google-Maps
Univ.Klinik für Kinder- und Jugendheilkunde Graz, Klin. Abteilung für pädiatrische Hämato-Onkologie
8036 Graz
AustriaRekrutierend» Google-Maps
Univ.Klinik für Kinder- und Jugendheilkunde Innsbruck, Universitätsklinik für Pädiatrie I
6020 Innsbruck
AustriaRekrutierend» Google-Maps
Kepler Universitätsklinikum, Med Campus IV / Onkologie
4020 Linz
AustriaRekrutierend» Google-Maps
LKH Salzburg, Universitätsklinik für Kinder- und Jugendheilkunde, Kinderonkologie
5020 Salzburg
AustriaRekrutierend» Google-Maps
Hôpital Universitaire des Enfants Reine Fabiola (ULB), Pédiatrie hémato-oncologie
1020 Brussels
BelgiumNoch nicht rekrutierend» Google-Maps
University Hospital Brussels, Pediatrische oncologie
1090 Brussel
BelgiumNoch nicht rekrutierend» Google-Maps
Cliniques Universitaires Saint-Luc (UCL), Hématologie et oncologie pédiatrique
1200 Brussel
BelgiumNoch nicht rekrutierend» Google-Maps
UZ Antwerpen Kinderhemato-oncologie
2650 Edegem
BelgiumNoch nicht rekrutierend» Google-Maps
University Hospital Gent Pediatrische hemato-oncologie
9000 Gent
BelgiumNoch nicht rekrutierend» Google-Maps
University Hospitals Leuven, Kinderhemato-oncologie
3000 Leuven
BelgiumNoch nicht rekrutierend» Google-Maps
CHR Citadelle Hémato - oncologie pédiatrique
4000 Liège
BelgiumNoch nicht rekrutierend» Google-Maps
CHR Citadelle Hémato - oncologie pédiatrique
4000 Montegnée
BelgiumNoch nicht rekrutierend» Google-Maps
Hong Kong Children's Hospital
Hong Kong
ChinaNoch nicht rekrutierend» Google-Maps
Dept. of Pediatric Oncology, University Hospital Brno and Faculty of Medicine, Masaryk University Cernopolni
662 63 Brno
CzechiaRekrutierend» Google-Maps
Dept. of Pediatric Hematology and Oncology. University Hospital Motol and 2nd Medical School, Charles University
160 06 Praha
CzechiaRekrutierend» Google-Maps
University Hospital Aalborg, Nord, Department of Pediatrics
9000 Aalborg
DenmarkNoch nicht rekrutierend» Google-Maps
Aarhus University Hospital, Department of Pediatrics
8200 Aarhus
DenmarkNoch nicht rekrutierend» Google-Maps
Børneonkologisk afsnit 5054, BørneUngeKlinikken, Juliane Marie Centret, Rigshospitalet
2100 Ø Kobenhavn
DenmarkRekrutierend» Google-Maps
H.C. Andersens Children Hospital, Odense University Hospital
5000 Odense
DenmarkNoch nicht rekrutierend» Google-Maps
Helsinki University Hospital, Department of Pediatric Hematology and Oncology
00029 HUS Helsinki
FinlandNoch nicht rekrutierend» Google-Maps
Kuopio University Hospital, Department of Pediatric Hematology and Oncology
70029 KYS Kuopio
FinlandNoch nicht rekrutierend» Google-Maps
University Hospital of Oulu, Paediatric Haematology and Oncology
90029 OYS Oulu
FinlandNoch nicht rekrutierend» Google-Maps
Tampere University Hospital, Paediatric Haematology and Oncology
33521 Tampere Tampere
FinlandNoch nicht rekrutierend» Google-Maps
Turku University Hospital, Paediatric and Adolescent Haematology and Oncology
20521 Turku Turku
FinlandNoch nicht rekrutierend» Google-Maps
Service d'oncolologie, Hématologie pédiatrique. CHU Amiens, Avenue René Laënnec - SALOUEL
80054 Amiens
FranceNoch nicht rekrutierend» Google-Maps
Pôle Femme Mère Enfant ; Unité d'Hématologie/Oncologie pédiatrique, CHU Angers
49033 Angers
FranceNoch nicht rekrutierend» Google-Maps
Hématologie Oncologie pédiatrique, CHRU Besançon
25030 Besançon
FranceNoch nicht rekrutierend» Google-Maps
Hôpital de Enfants, Unité Onco-Hématologie Pédiatrique, Groupe Hospitalier Pellegrin
33076 Bordeaux
FranceNoch nicht rekrutierend» Google-Maps
Département de Pédiatrie et Génétique Médicale CHRU Morvan
29609 Brest
FranceNoch nicht rekrutierend» Google-Maps
Unité d'hémato-immuno-oncologie pédiatrique. Centre Hospitalier Universitaire niveau 1 - bâtiment FEH
14033 Caen
FranceNoch nicht rekrutierend» Google-Maps
Unité Onco- Hématologie Pédiatrique CHU Estaing 1 place Lucie-Aubrac
63303 Clermont-Ferrand
FranceNoch nicht rekrutierend» Google-Maps
Service Immuno-Hématologie Oncologie Pédiatrique
21079 Dijon
FranceNoch nicht rekrutierend» Google-Maps
Service onco hématologie pédiatrique CHU de Grenoble site Nord - Hôpital Couple enfant
38043 Grenoble
FranceNoch nicht rekrutierend» Google-Maps
Unité d'hématologie pédiatrique CHRU de Lille - Hôpital Jeanne de Flandre
59037 Lille
FranceNoch nicht rekrutierend» Google-Maps
Service d'Hématologie - Oncologie pédiatrique CHU Limoges - Hôpital de la mère et de l'enfant
87042 Limoges
FranceNoch nicht rekrutierend» Google-Maps
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
69373 Lyon
FranceNoch nicht rekrutierend» Google-Maps
Service de Pédiatrie et hématologie pédiatrique, CHU de Marseille - Hôpital de la Timone
13385 Marseille
FranceNoch nicht rekrutierend» Google-Maps
UAM Hématologie et Oncologie Pédiatrique, CHU de Montpellier - Hôpital Arnaud de Villeneuve
34295 Montpellier
FranceNoch nicht rekrutierend» Google-Maps
Service d'hématologie et oncologie pédiatriques, Hôpital enfant-adolescent, CHU NANTES
44093 Nantes
FranceNoch nicht rekrutierend» Google-Maps
Service d'hémato-oncologie pédiatrique CHU NICE - Hôpital l'Archet 2
06200 Nice
FranceNoch nicht rekrutierend» Google-Maps
service d'oncologie pédiatrique, institut Curie
75005 Paris
FranceNoch nicht rekrutierend» Google-Maps
Service Hémato-immuno- oncologie- CHU PARIS Armand Trousseau
75012 Paris
FranceNoch nicht rekrutierend» Google-Maps
Service d' hémato-immunologie CHU Paris - Hôpital Robert Debré
75019 Paris
FranceNoch nicht rekrutierend» Google-Maps
Service Oncologie-Hématologie pédiatrique CHU de Poitiers
86000 Poitiers
FranceNoch nicht rekrutierend» Google-Maps
Service d'Hémato-Oncologie Pédiatrique- American Hospital
51100 Reims
FranceNoch nicht rekrutierend» Google-Maps
Pôle pédiatrie Hémato-cancérologie pédiatrique- CHU RENNES - Hôpital sud
35203 Rennes
FranceNoch nicht rekrutierend» Google-Maps
Service d'Hemato-Oncologie Pediatrique CHU Rouen
76031 Rouen
FranceNoch nicht rekrutierend» Google-Maps
service d'oncologie pédiatrique, hopital Félix Guyon
97405 Saint-Denis
FranceNoch nicht rekrutierend» Google-Maps
Pôle mère enfant-Unité Hématologie - Oncologie pédiatrique - CHU Hôpital NORD
42270 Saint-Priest-en-Jarez
FranceNoch nicht rekrutierend» Google-Maps
Service d'Onco-Hematologie Pediatrique CHU STRASBOURG -Hôpital de Hautepierre
67098 Strasbourg
FranceNoch nicht rekrutierend» Google-Maps
Service Pédiatrie - Hématologie Immunologie Oncologie - CHU Toulouse
31059 Toulouse
FranceNoch nicht rekrutierend» Google-Maps
Service d'hémato-oncologie pédiatrique- CHU de Nancy - Hôpital de Brabois Enfant
54511 Vandœuvre-lès-Nancy
FranceNoch nicht rekrutierend» Google-Maps
Dépt de Pédiatrie Gustave Roussy
94805 Villejuif
FranceNoch nicht rekrutierend» Google-Maps
2nd Dep. of Pediatrics, Semmelweis Univ
Budapest
HungaryNoch nicht rekrutierend» Google-Maps
Heim Pal Children Hospital
Budapest
HungaryNoch nicht rekrutierend» Google-Maps
Dep. of Pediatrics, Univ. of Debrecen
Debrecen
HungaryNoch nicht rekrutierend» Google-Maps
Children's Treating Center, Miskolc
Miskolc
HungaryNoch nicht rekrutierend» Google-Maps
Dep. of Pediatrics, University of Pecs
Pécs
HungaryNoch nicht rekrutierend» Google-Maps
Dep. of Pediatrics, Univ. of Szeged
Szeged
HungaryNoch nicht rekrutierend» Google-Maps
Our Lady's Children's Hospital Crumlin
Dublin
IrelandNoch nicht rekrutierend» Google-Maps
Children's Hospital at Soroka Medical Center
Be'er Sheva
IsraelNoch nicht rekrutierend» Google-Maps
Ruth Rappaport Children's Hospital, Rambam Medical Center
Haifa
IsraelNoch nicht rekrutierend» Google-Maps
Children's Hospital at Hadassah, Ein Kerem Medical Center
Jerusalem
IsraelNoch nicht rekrutierend» Google-Maps
Schneider Children's hospital, Rabin Medical Center
Petah tikva
IsraelNoch nicht rekrutierend» Google-Maps
Edmond and Lily Safra Children's Hospital, Sheba Medical Center
Ramat Gan
IsraelNoch nicht rekrutierend» Google-Maps
Dana Children's Hospital, Tel-Aviv Sourasky Medical Center
Tel Aviv
IsraelNoch nicht rekrutierend» Google-Maps
Clinica Pediatrica, Centro Regionale Oncoematologia Pediatrica- Ospedale dei Bambini "G. Salesi"
60123 Ancona
ItalyNoch nicht rekrutierend» Google-Maps
Dipartimento Biomedicina Età Evolutiva- U.O. Pediatrica I Policlinico
70124 Bari
ItalyNoch nicht rekrutierend» Google-Maps
Dipartimento Pediatrico degli OO.RR. di Bergamo
24100 Bergamo
ItalyNoch nicht rekrutierend» Google-Maps
Dipartimento di Scienze Pediatriche Mediche Chirurgiche Ospedale Sant'Orsola Malpighi
40138 Bologna
ItalyNoch nicht rekrutierend» Google-Maps
Clinica Pediatrica Ospedale Civile
25123 Brescia
ItalyNoch nicht rekrutierend» Google-Maps
Istituto di Clinica Pediatrica- Ospedale Regionale Microcitemie
09121 Cagliari
ItalyNoch nicht rekrutierend» Google-Maps
Divisione Ematologia - Oncologia Pediatrica, Clinica Pediatrica
95123 Catania
ItalyNoch nicht rekrutierend» Google-Maps
U. O. di Pediatria- Azienda Ospedaliera Annunziata
87100 Cosenza
ItalyNoch nicht rekrutierend» Google-Maps
Dipartimento di Medicina Clinica e Sperimentale Sezione di Pediatria - Università di Ferrara
44100 Ferrara
ItalyNoch nicht rekrutierend» Google-Maps
Unità Autonoma di Oncoematologia Pediatrica, Dipartimento Pediatria - Azienda "A.Meyer"
50132 Firenze
ItalyNoch nicht rekrutierend» Google-Maps
Dipartimento di Ematologia e Oncologia Pediatrica Istituto " G. Gaslini"
16148 Genova
ItalyNoch nicht rekrutierend» Google-Maps
Divisione di Oncologia Pediatrica Ist. Nazionale Studio e Cura Tumori
20133 Milano
ItalyNoch nicht rekrutierend» Google-Maps
U.O. di Ematologia, Oncologia e Trapianto-Azienda Policlinico di Modena
41100 Modena
ItalyNoch nicht rekrutierend» Google-Maps
Clinica Pediatrica Ospedale S. Gerardo Via Donizetti
20052 Monza
ItalyNoch nicht rekrutierend» Google-Maps
S.C. Ematologia Oncologica- Ospedale "Pausilipon"
80123 Napoli
ItalyNoch nicht rekrutierend» Google-Maps
Clinica di Oncoematologia Pediatrica- Azienda Ospedaliera-Università di Padova
35128 Padova
ItalyNoch nicht rekrutierend» Google-Maps
Oncoematologia Pediatrica- Ospedale dei Bambini G. di Cristina
90100 Palermo
ItalyNoch nicht rekrutierend» Google-Maps
U.O. di Pediatria e Oncoematologia Pediatrica. Az. Osp. di Parma
43100 Parma
ItalyNoch nicht rekrutierend» Google-Maps
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Alle anzeigen

Studien-Informationen

Detailed Description:

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

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

Primary objectives:

- Randomization R1, all patients eligible: To examine, whether the cumulative incidence of relapses with involvement of the CNS (CNS relapse, pCICR) can be decreased by a modified induction therapy including dexamethasone (experimental arm) instead of prednisone (standard arm)

- Randomization R2, only patients with high risk LBL eligible: to examine, whether the probability of event-free survival (pEFS) in these patients can be improved by receiving an intensified treatment arm versus a standard treatment arm (as used in the EURO-LB 02)

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

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

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

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

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

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

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

2. Estimated probability of event-free survival (pEFS) (Time Frame - through study completion, maximal 7.25 years):
The pEFS is defined as the time from randomization to the first event (non-response, progressive disease, relapse, second malignancy or death from any cause) or date of last follow-up.

Secondary outcome:

1. Survival (pOS) (Time Frame - through study completion, maximal 7.25 years):
Survival (pOS) is defined as time from diagnosis to death due to any cause or to the date of last contact for patients alive

2. 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)

3. 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)

4. Frequency of adverse events of interest and severe adverse events overall (Time Frame - through study completion, maximal 7.25 years)

5. Rate of evaluable patients for risk group stratification (Time Frame - during recruitment)

6. Cumulative incidence of relapses in association with molecular markers (Time Frame - through study completion, maximal 7.25 years)

7. Cumulative incidence of relapses in association with minimal residual disease results (Time Frame - through study completion, maximal 7.25 years)

Studien-Arme

  • Other: SR I/II: R1 into protocol Ia-Pred
    cytoreductive prephase with prednisone standard induction phase (protocol Ia-prednisone) consolidation phase (protocol Ib) non-HR extra-compartment phase (protocol M) maintenance therapy
  • Experimental: SR I/II: R1 into protocol Ia-Dexa
    cytoreductive prephase with prednisone experimental induction phase (protocol Ia-dexamethasone) consolidation phase (protocol Ib) non-HR extra-compartment Phase (protocol M) maintenance therapy
  • Other: SR: R1 into protocol Ia-Pred
    cytoreductive prephase with prednisone standard induction phase (protocol Ia-prednisone) consolidation phase (protocol Ib) non-HR extra-compartment phase (protocol M) reintensification phase (protocol II) maintenance therapy
  • Experimental: SR: R1 into protocol Ia-Dexa
    cytoreductive prephase with prednisone experimental induction phase (protocol Ia-dexamethasone) consolidation phase (protocol Ib) non-HR extra-compartment phase (protocol M) reintensification phase (protocol II) maintenance therapy
  • Other: HR: R1 into "Pred" and R2 into non-HR extra-compartment phase
    cytoreductive prephase with prednisone standard induction phase (protocol Ia-prednisone) consolidation phase (protocol Ib) non-HR extra-compartment phase (protocol M) reintensification phase (protocol II) maintenance therapy
  • Experimental: HR: R1 into "Dexa" and R2 into non-HR extra-compartment phase
    cytoreductive prephase with prednisone experimental induction phase (protocol Ia-dexamethasone) consolidation phase (protocol Ib) non-HR extra-compartment phase (protocol M) reintensification phase (protocol II) maintenance therapy
  • Experimental: HR: R1 into "Pred" and R2 into HR extra-compartment phase
    cytoreductive prephase with prednisone standard induction phase (protocol Ia-prednisone) consolidation phase (protocol Ib*) HR extra-compartment phase (intensified protocol M) reintensification phase (protocol II) maintenance therapy
  • Experimental: HR: R1 into "Dexa" and R2 into HR extra-compartment phase
    cytoreductive prephase with prednisone experimental induction phase (protocol Ia-dexamethasone) consolidation phase (protocol Ib*) HR extra-compartment phase (intensified protocol M) reintensification phase (protocol II) maintenance therapy

Geprüfte Regime

  • Cyclophosphamide:
    Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
  • Cytarabine:
    No involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2). Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
  • Dexamethasone:
    Part of the experimental therapy in Randomization R1 (Protocol Ia-Dexamethasone) and in Randomization R2 (Intensified Protocol M)
  • Daunorubicin:
    Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
  • Doxorubicin:
    Part of standard chemotherapy
  • Ifosfamide:
    Part of the experimental therapy in Randomization R2 (Intensified Protocol M)
  • 6-Mercaptopurine:
    Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
  • Methotrexate:
    Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
  • PEG asparaginase:
    Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Protocol Ib* (Randomization R2)
  • Prednisone:
    Part of standard chemotherapy
  • Prednisolone:
    No involvement of CNS: Part of standard chemotherapy. Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2
  • Thioguanine:
    Part of standard chemotherapy
  • Vincristine:
    Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
  • Vindesine:
    Part of the experimental therapy in Randomization R2 (Intensified Protocol M)

Quelle: ClinicalTrials.gov


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