Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

1,800

Participants

Timeline

Start Date

April 30, 2013

Primary Completion Date

June 30, 2025

Study Completion Date

April 30, 2030

Conditions
Acute Lymphoblastic Leukaemia
Interventions
DRUG

VP16

60 mg/kg BW,1 day in TBI/VP16 conditioning; 40 mg/kg BW in Bu/VP16/Cy conditioning

RADIATION

TBI

2 x 2Gy/day , 3 days (total 12Gy)

DRUG

Thiotepa

2x5 mg/kg BW, 1 day

DRUG

Treosulfan

14g/m² BS, 3 days

DRUG

Fludarabine

30 mg/m² BS, 5 days

DRUG

Busulfan

iV, dosage according therapeutic drug monitoring, 4 days

DRUG

ATG Thymoglobulin

MD: ATG Thymo: 2,5mg/kg BW/d 3 days.

DRUG

Cyclophosphamide

as part of conditioning 60 mg/kg BW 2 days or as GvHD Prophylaxis 50mg/kg BW/d 2 days with Mesna

DRUG

Grafalon

MD: 15mg/kg BW/d 3 days MMD: 10mg/kg BW/d 3 days

Trial Locations (119)

1020

RECRUITING

Hôpital Universitaire des Enfants Reine Fabiola (HUDERF), Brussels

1054

ACTIVE_NOT_RECRUITING

Universitätsklinikum Erlangen, Kinder- und Jugendklinik, Erlangen

1090

RECRUITING

St. Anna Children's Hospital, Vienna, Austria, Vienna

1097

RECRUITING

National Institute of Haematology and Infectious Disease, Hospital of Southern Pest, Paediatric Bone Marrow Transplantation Unit, Budapest

1142

ACTIVE_NOT_RECRUITING

Starship Children's Hospital, Auckland

1200

RECRUITING

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

1211

RECRUITING

HUG Hôpitaux Universitaire de Genève, Geneva

1651

RECRUITING

Hospital Sor Maria Ludovica, Department Hematology Stem Cell Transplant Unit, La Plata

2031

ACTIVE_NOT_RECRUITING

Sydney Children's Hospital, Randwick

2100

RECRUITING

Paediatric Stem Cell Transplant and Immune Deficiency, Dept. for children and adolescents 4072, Rigshospitalet, Copenhagen

2145

ACTIVE_NOT_RECRUITING

The Children's Hospital at Westmead Oncology Unit, Sydney

2300

RECRUITING

Leiden University Medical Center Department of Pediatrics/BMT unit, Leiden

3000

RECRUITING

University Hospitals Leuven Kinderhemato-oncologie, Leuven

3052

ACTIVE_NOT_RECRUITING

Children's Cancer Centre The Royal Children's Hospital, Melbourne

3584

RECRUITING

Princess Máxima Center for Pediatric Oncology, Utrecht

4056

RECRUITING

Universitäts-Kinderspital beider Basel (UKBB), Basel

4101

ACTIVE_NOT_RECRUITING

Lady Cilento Children's Hospital, South Brisbane

6008

ACTIVE_NOT_RECRUITING

Princess Margaret Hospital for Children, Perth

6020

RECRUITING

Universitätsklinik für Kinder- und Jugendheilkunde, Innsbruck

8032

RECRUITING

Universitäts-Kinderspital Zurich, Zurich

8036

RECRUITING

Universitätsklinik für Kinder- und Jugendheilkunde, Abt. f. Hämato-Onkologie, Graz

9000

RECRUITING

University Hospital Gent Pediatrische hemato-oncologie, Ghent

10126

TERMINATED

Ospedale Infantile Regina Margherita SC Oncoematologia e Centro Trapianti, Torino

11527

RECRUITING

Saint Sophia Children's Hospital BMT Unit, Athens

13353

ACTIVE_NOT_RECRUITING

Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Berlin

13385

ACTIVE_NOT_RECRUITING

Hopital la Timone Adulte, Marseille

14186

RECRUITING

Karolinska University Hospital, Department of Pediatrics, Stockholm

16147

NOT_YET_RECRUITING

Istituto Gaslini Genova Oncoematologia Pediatrica-, Genoa

17475

ACTIVE_NOT_RECRUITING

Universitätsmedizin Greifswald, Klinik und Poliklinik für Kinder- und Jugendmedizin, Greifswald

20246

ACTIVE_NOT_RECRUITING

Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Pädiatrische Hämatologie und Onkologie, Hamburg

20900

RECRUITING

A.O. San Gerardo di Monza Clinica Pediatrica, Monza

22185

RECRUITING

Skane University Hospital, Dept. of Pediatrics, Section for Hematology and Oncology, Lund

24105

ACTIVE_NOT_RECRUITING

UKSH - Universitätsklinikum Schleswig-Holstein, Klinik für Allgemeine Pädiatrie, Kiel

27100

RECRUITING

Fondazione IRCCS Policlinico San Matteo, Pavia

30625

ACTIVE_NOT_RECRUITING

Medizinische Hochschule Hannover, Zentrum Kinderheilkunde und Jugendmedizin, Hanover

31096

RECRUITING

Rambam Medical Center, Haifa

33076

ACTIVE_NOT_RECRUITING

CHU Bordeaux, Bordeaux

34295

ACTIVE_NOT_RECRUITING

Hopital Arnaud de Villeneuve, Montpellier

35128

NOT_YET_RECRUITING

Azienda Ospedaliera di Padova Oncoematologia Pediatrica, Padua

35203

ACTIVE_NOT_RECRUITING

CHU de Rennes, Serive d'Onco-Pédiatrie, Rennes

35392

ACTIVE_NOT_RECRUITING

Universitätsklinikum Gießen, Zentrum für Kinder- und Jugendmedizin, Giessen

38043

ACTIVE_NOT_RECRUITING

CHU Grenoble - Clinique Universitaire de Pédiatrie, Hôpital Couple Enfant, Grenoble

40138

NOT_YET_RECRUITING

Azienda Ospedaliero-Universitaria Policlinico S. Orsola-Malpighi di Bologna, Bologna

40225

ACTIVE_NOT_RECRUITING

Universitätsklinikum Düsseldorf, Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immunologie, Düsseldorf

41685

RECRUITING

Queen Silvia Children's Hospital, Department of Pediatric Oncology (Avdelnig 321-322), Gothenburg

44093

ACTIVE_NOT_RECRUITING

CHU Nantes, Service d'onco hémato pédiatrie, Nantes

45122

ACTIVE_NOT_RECRUITING

Universitätsklinikum Essen, Klinik für Kinderheilkunde III, Essen

48149

ACTIVE_NOT_RECRUITING

Universitätsklinikum Münster, Klinik für Kinder- und Jugendmedizin, Münster

49202

RECRUITING

Schneider Children's Medical Center of Israel, Petah Tikva

50139

WITHDRAWN

Ospedale Mayer di Firenze SODc Tumori Pediatrici e TMO, Florence

52074

ACTIVE_NOT_RECRUITING

Uniklinik RWTH Aachen, Kinder- und Jugendmedizin, Aachen

53113

ACTIVE_NOT_RECRUITING

Universitätsklinikum Bonn, Abteilung für Pädiatrische Hämatologie und Onkologie, Bonn

54500

ACTIVE_NOT_RECRUITING

CHU Nancy - Hopital d'Enfants, Nancy

56126

NOT_YET_RECRUITING

Azienda Ospedaliero Universitaria Pisana U.O. di Oncoematologia Pediatrica A.O., Pisa

59037

ACTIVE_NOT_RECRUITING

CHRU Lille, Service d'Hématologie Pédiatrique, Lille

60590

ACTIVE_NOT_RECRUITING

Klinikum der Johann Wolfgang Goethe-Universität, Klinik für Kinder- und Jugendmedizin (KKJM), Frankfurt am Main

63003

ACTIVE_NOT_RECRUITING

CHU Clermont-Ferrand, Clermont-Ferrand

64239

RECRUITING

Dana Children's Hospital, Tel Aviv

67098

ACTIVE_NOT_RECRUITING

CHU Strasbourg, Service d'hématologie et d'oncologie pédiatrique, Strasbourg

69120

ACTIVE_NOT_RECRUITING

Universitätsklinikum Heidelberg, Zentrum für Kinder- und Jugendmedizin, Heidelberg

69372

ACTIVE_NOT_RECRUITING

IHOP / Lyon, Service Hématologie et d'Oncologie pédiatrique, Lyon

72076

ACTIVE_NOT_RECRUITING

Universitätsklinik für Kinder- und Jugendmedizin Tübingen, Tübingen

75019

ACTIVE_NOT_RECRUITING

Hôpital Robert Debré, Paris

75185

RECRUITING

University Children's Hospital, Dept. of Women's & Children's Health Section for Pediatrics, Uppsala

76031

ACTIVE_NOT_RECRUITING

CHU de Rouen, Hopital des Enfants, Service d' Immuno-Hématologie Oncologie Pédiatrique, Rouen

79106

ACTIVE_NOT_RECRUITING

Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin, Freiburg im Breisgau

80123

NOT_YET_RECRUITING

A.O.R.N. Santobono Pausilipon, Dipartimento di Oncoematologia, Napoli

80337

ACTIVE_NOT_RECRUITING

Klinikum der Universität München, Dr. von Haunersches Kinderspital, München

80804

ACTIVE_NOT_RECRUITING

Städt. Krankenhaus München Schwabing, Universitätskinderklinik der TU München, München

83340

RECRUITING

University Children's Hospital, Bratislava

89075

ACTIVE_NOT_RECRUITING

Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin, Ulm

93053

ACTIVE_NOT_RECRUITING

Universitätsklinikum Regensburg, Klinik und Poliklinik für Kinder- und Jugendmedizin, Regensburg

97080

ACTIVE_NOT_RECRUITING

Universitäts-Kinderklinik Würzburg, Würzburg

Unknown

RECRUITING

"Hospital de Pediatria Juan P. Garrahan Combate de Los Pozos N°1800 CABA", Buenos Aires

RECRUITING

Belarusian Research Center for Pediatric Oncology, Hematology and Immunology, Minsk

RECRUITING

Centre Hospitalier Universitaire de Liège Domaine Universitaire du Sart Tilman, Liège

ACTIVE_NOT_RECRUITING

Alberta Children's Hospital Division of Pediatric Oncology, Calgary

ACTIVE_NOT_RECRUITING

Montreal Children's Hospital, Montral

RECRUITING

CHU Sainte-Justine Hematology-Oncology Division, Montreal

RECRUITING

Hospital for Sick Children University of Toronto Division of Haematology/Oncology, Toronto

RECRUITING

BC Children's Hospital, Vancouver

NOT_YET_RECRUITING

CancerCare Manitoba/University of Manitoba, Winnipeg

RECRUITING

Hospital Dr Luis Calvo Mackenna, Santiago

RECRUITING

Department of Pediatrics, UHC Zagreb, Zagreb

RECRUITING

University of Malaya, Department of Paediatrics, Kuala Lumpur

RECRUITING

Instituto Nacional de Peditria, Mexico City

RECRUITING

University Hospital No.1, Collegium Medicum UMK, department of Paediatrics, Oncology, Hematology and Paediatric Transplantology, Bydgoszcz

WITHDRAWN

University Children's Hospital in Krakow, Department of Transplantation, Krakow

NOT_YET_RECRUITING

Children's University Hospital, Dept. Pediatric Hematology, Oncology, and Transplantology, Lublin

RECRUITING

Poznan University of Medical Sciences, Department of Pediatric Onology, Hematology & HSCT, Poznan

RECRUITING

Cape of Hope, Wroclaw Medical University, Wroclaw

RECRUITING

IInsitutul Clinic Fundeni, Sectia de Transplant Medular, Bucharest

RECRUITING

University of Medicine and Pharmacy V. BABES, Emergency Children's Hospital LOUIS TURCANU, III. Clinic of Pediatrics , Department of Onco-hematology and Bone Marrow Transplantation, Timișoara

RECRUITING

King Abdullah specialists children hospital, Riyadh

RECRUITING

University childrens' hospital, UMCL, Ljubljana

RECRUITING

Hospital Santa Creu i Sant Pau, Barcelona

RECRUITING

Hospital Vall d'Hebron, Barcelona

NOT_YET_RECRUITING

Hospital Materno Infantil de Málaga, Málaga

RECRUITING

Hospital Virgen de la Arrixaca, Murcia

RECRUITING

Hospital Universitario Central de Asturias, Oviedo

RECRUITING

Gazi University School of Medicine Pediatric Stem Cell Transplantation Unit, Ankara

RECRUITING

Gülhane Training and Research Hospital, Ankara

RECRUITING

Akdeniz University School of Medicine Pediatric Stem Cell Transplantation Unit, Antalya

RECRUITING

Bahcesehir University School of Medicine Pediatric Stem Cell Transplantation Unit, Antalya

RECRUITING

Acibadem University Atakent Hospital Pediatric Stem Cell Transplantation Unit, Istanbul

RECRUITING

Bahcelievler Medicalpark Hospital Pediatric Stem Cell Transplantation Unit, Istanbul

RECRUITING

Bahcesehir University School of Medicine Pediatric Stem Cell Transplantation Unit, Istanbul

RECRUITING

Medipol Mega Üniversite Hastanesi, Istanbul

RECRUITING

Dokuzeylul University School of Medicine Pediatric Stem Cell Transplantation Unit, Izmir

RECRUITING

Ege University School of Medicine Pediatric Stem Cell Transplantation Unit, Izmir

RECRUITING

Erciyes University School of Medicine Pediatric Stem Cell Transplantation Unit, Kayseri

150 06

RECRUITING

Department of Pediatric Hematology and Oncology Teaching Hospital Motol, 2nd Medical School, Charles University, Prague

00029 HUS

RECRUITING

Division of Hematology-Oncology and Stem Cell Transplantation, Hospital for Children and Adolescents, Univ. of Helsinki, Helsinki

06120

ACTIVE_NOT_RECRUITING

Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Kinder- und Jugendmedizin, Halle

07745

ACTIVE_NOT_RECRUITING

Universitätsklinikum Jena, Sektion für Stammzelltransplantation, Jena

04103

ACTIVE_NOT_RECRUITING

Universitätsmedizin Leipzig, Abteilung für Pädiatrische Onkologie, Hämatologie und Hämostaseologie, Leipzig

00165

RECRUITING

Ospedale Pediatrico Bambino Gesù, Sapienza, University of Rome, Rome

0424

RECRUITING

Oslo University Hospital Rikshospitalet, Oslo

06100

RECRUITING

Ankara University School of Medicine Pediatric Stem Cell Transplantation Unit, Ankara

All Listed Sponsors
collaborator

ALL SCTped Forum

OTHER

collaborator

European Society for Blood and Marrow Transplantation

NETWORK

collaborator

ALL-BFM Study Group

NETWORK

collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

collaborator

Dutch Childhood Oncology Group

OTHER

collaborator

Swiss Pediatric Oncology Group

OTHER

collaborator

Australian & New Zealand Children's Haematology/Oncology Group

OTHER

lead

St. Anna Kinderkrebsforschung

OTHER