Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia
Who is this study for? Child patients with Acute Lymphoblastic Leukemia
Status: Recruiting
Location: See all (118) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
The ALL SCTped 2012 FORUM is a multinational, multi-centre, controlled, prospective phase III study for the therapy and therapy optimisation for children and adolescents with ALL in complete morphological remission (CR, less than 5% bone marrow blasts, no blasts in cerebrospinal fluid, no other extramedullary leukemia), who have an indication for HSCT with a myeloablative conditioning regimen. The stratification of patients in first and following remissions according to the individual transplantation modalities rests upon an indication for allogeneic HSCT and the availability of a suitable donor within the individual transplantation groups.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 18
Healthy Volunteers: f
View:
⁃ Patients with ALL (except for patients with B-ALL) who fulfil the following criteria:
• age at diagnosis ≤ 18 years. Age at HSCT ≤ 21 years
• indication for allogeneic HSCT
• complete remission (CR) before HSCT
• written consent of the parents (legal guardian) and, if necessary, the minor patient via Informed Consent Form
• no pregnancy
• no secondary malignancy
• no previous HSCT
• HSCT is performed in a study participating centre
Locations
Other Locations
Argentina
Hospital de Pediatria Juan P. Garrahan Combate de Los Pozos N°1800 CABA
RECRUITING
Buenos Aires
Hospital Sor Maria Ludovica, Department Hematology Stem Cell Transplant Unit
RECRUITING
La Plata
Australia
Children's Cancer Centre The Royal Children's Hospital
ACTIVE_NOT_RECRUITING
Melbourne
Princess Margaret Hospital for Children
ACTIVE_NOT_RECRUITING
Perth
Sydney Children's Hospital
ACTIVE_NOT_RECRUITING
Randwick
Lady Cilento Children's Hospital
ACTIVE_NOT_RECRUITING
South Brisbane
The Children's Hospital at Westmead Oncology Unit
ACTIVE_NOT_RECRUITING
Sydney
Austria
Universitätsklinik für Kinder- und Jugendheilkunde, Abt. f. Hämato-Onkologie
RECRUITING
Graz
Universitätsklinik für Kinder- und Jugendheilkunde
RECRUITING
Innsbruck
St. Anna Children's Hospital, Vienna, Austria
RECRUITING
Vienna
Belarus
Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
RECRUITING
Minsk
Belgium
Cliniques Universitaires Saint-Luc (UCL) Hématologie et oncologie pédiatrique
RECRUITING
Brussels
Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)
RECRUITING
Brussels
University Hospital Gent Pediatrische hemato-oncologie
RECRUITING
Ghent
University Hospitals Leuven Kinderhemato-oncologie
RECRUITING
Leuven
Centre Hospitalier Universitaire de Liège Domaine Universitaire du Sart Tilman
RECRUITING
Liège
Canada
Alberta Children's Hospital Division of Pediatric Oncology
ACTIVE_NOT_RECRUITING
Calgary
Montreal Children's Hospital
ACTIVE_NOT_RECRUITING
Montral
CHU Sainte-Justine Hematology-Oncology Division
RECRUITING
Montreal
Hospital for Sick Children University of Toronto Division of Haematology/Oncology
RECRUITING
Toronto
BC Children's Hospital
RECRUITING
Vancouver
CancerCare Manitoba/University of Manitoba
NOT_YET_RECRUITING
Winnipeg
Chile
Hospital Dr Luis Calvo Mackenna
RECRUITING
Santiago
Croatia
Department of Pediatrics, UHC Zagreb
RECRUITING
Zagreb
Denmark
Paediatric Stem Cell Transplant and Immune Deficiency, Dept. for children and adolescents 4072, Rigshospitalet
RECRUITING
Copenhagen
Finland
Division of Hematology-Oncology and Stem Cell Transplantation, Hospital for Children and Adolescents, Univ. of Helsinki
RECRUITING
Helsinki
France
CHU Bordeaux
ACTIVE_NOT_RECRUITING
Bordeaux
CHU Clermont-Ferrand
ACTIVE_NOT_RECRUITING
Clermont-ferrand
CHU Grenoble - Clinique Universitaire de Pédiatrie, Hôpital Couple Enfant
ACTIVE_NOT_RECRUITING
Grenoble
CHRU Lille, Service d'Hématologie Pédiatrique
ACTIVE_NOT_RECRUITING
Lille
IHOP / Lyon, Service Hématologie et d'Oncologie pédiatrique
ACTIVE_NOT_RECRUITING
Lyon
Hopital la Timone Adulte
ACTIVE_NOT_RECRUITING
Marseille
Hopital Arnaud de Villeneuve
ACTIVE_NOT_RECRUITING
Montpellier
CHU Nancy - Hopital d'Enfants
ACTIVE_NOT_RECRUITING
Nancy
CHU Nantes, Service d'onco hémato pédiatrie
ACTIVE_NOT_RECRUITING
Nantes
Hôpital Robert Debré
ACTIVE_NOT_RECRUITING
Paris
CHU de Rennes, Serive d'Onco-Pédiatrie
ACTIVE_NOT_RECRUITING
Rennes
CHU de Rouen, Hopital des Enfants, Service d' Immuno-Hématologie Oncologie Pédiatrique
ACTIVE_NOT_RECRUITING
Rouen
CHU Strasbourg, Service d'hématologie et d'oncologie pédiatrique
ACTIVE_NOT_RECRUITING
Strasbourg
Germany
Uniklinik RWTH Aachen, Kinder- und Jugendmedizin
ACTIVE_NOT_RECRUITING
Aachen
Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum
ACTIVE_NOT_RECRUITING
Berlin
Universitätsklinikum Bonn, Abteilung für Pädiatrische Hämatologie und Onkologie
ACTIVE_NOT_RECRUITING
Bonn
Universitätsklinikum Düsseldorf, Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immunologie
ACTIVE_NOT_RECRUITING
Düsseldorf
Universitätsklinikum Erlangen, Kinder- und Jugendklinik
ACTIVE_NOT_RECRUITING
Erlangen
Universitätsklinikum Essen, Klinik für Kinderheilkunde III
ACTIVE_NOT_RECRUITING
Essen
Klinikum der Johann Wolfgang Goethe-Universität, Klinik für Kinder- und Jugendmedizin (KKJM)
ACTIVE_NOT_RECRUITING
Frankfurt Am Main
Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin
ACTIVE_NOT_RECRUITING
Freiburg Im Breisgau
Universitätsklinikum Gießen, Zentrum für Kinder- und Jugendmedizin
ACTIVE_NOT_RECRUITING
Giessen
Universitätsmedizin Greifswald, Klinik und Poliklinik für Kinder- und Jugendmedizin
ACTIVE_NOT_RECRUITING
Greifswald
Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Kinder- und Jugendmedizin
ACTIVE_NOT_RECRUITING
Halle
Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Pädiatrische Hämatologie und Onkologie
ACTIVE_NOT_RECRUITING
Hamburg
Medizinische Hochschule Hannover, Zentrum Kinderheilkunde und Jugendmedizin
ACTIVE_NOT_RECRUITING
Hanover
Universitätsklinikum Heidelberg, Zentrum für Kinder- und Jugendmedizin
ACTIVE_NOT_RECRUITING
Heidelberg
Universitätsklinikum Jena, Sektion für Stammzelltransplantation
ACTIVE_NOT_RECRUITING
Jena
UKSH - Universitätsklinikum Schleswig-Holstein, Klinik für Allgemeine Pädiatrie
ACTIVE_NOT_RECRUITING
Kiel
Universitätsmedizin Leipzig, Abteilung für Pädiatrische Onkologie, Hämatologie und Hämostaseologie
ACTIVE_NOT_RECRUITING
Leipzig
Klinikum der Universität München, Dr. von Haunersches Kinderspital
ACTIVE_NOT_RECRUITING
München
Städt. Krankenhaus München Schwabing, Universitätskinderklinik der TU München
ACTIVE_NOT_RECRUITING
München
Universitätsklinikum Münster, Klinik für Kinder- und Jugendmedizin
ACTIVE_NOT_RECRUITING
Münster
Universitätsklinikum Regensburg, Klinik und Poliklinik für Kinder- und Jugendmedizin
ACTIVE_NOT_RECRUITING
Regensburg
Universitätsklinik für Kinder- und Jugendmedizin Tübingen
ACTIVE_NOT_RECRUITING
Tübingen
Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin
ACTIVE_NOT_RECRUITING
Ulm
Universitäts-Kinderklinik Würzburg
ACTIVE_NOT_RECRUITING
Würzburg
Greece
Saint Sophia Children's Hospital BMT Unit
RECRUITING
Athens
Hungary
National Institute of Haematology and Infectious Disease, Hospital of Southern Pest, Paediatric Bone Marrow Transplantation Unit
RECRUITING
Budapest
Israel
Rambam Medical Center
RECRUITING
Haifa
Schneider Children's Medical Center of Israel
RECRUITING
Petah Tikva
Dana Children's Hospital
RECRUITING
Tel Aviv
Italy
Azienda Ospedaliero-Universitaria Policlinico S. Orsola-Malpighi di Bologna
NOT_YET_RECRUITING
Bologna
Ospedale Mayer di Firenze SODc Tumori Pediatrici e TMO
WITHDRAWN
Florence
Istituto Gaslini Genova Oncoematologia Pediatrica-
NOT_YET_RECRUITING
Genoa
A.O. San Gerardo di Monza Clinica Pediatrica
RECRUITING
Monza
A.O.R.N. Santobono Pausilipon, Dipartimento di Oncoematologia
NOT_YET_RECRUITING
Napoli
Azienda Ospedaliera di Padova Oncoematologia Pediatrica
NOT_YET_RECRUITING
Padua
Fondazione IRCCS Policlinico San Matteo
RECRUITING
Pavia
Azienda Ospedaliero Universitaria Pisana U.O. di Oncoematologia Pediatrica A.O.
NOT_YET_RECRUITING
Pisa
Ospedale Pediatrico Bambino Gesù, Sapienza, University of Rome
RECRUITING
Rome
Ospedale Infantile Regina Margherita SC Oncoematologia e Centro Trapianti
TERMINATED
Torino
Malaysia
University of Malaya, Department of Paediatrics
RECRUITING
Kuala Lumpur
Mexico
Instituto Nacional de Peditria
RECRUITING
Mexico City
Netherlands
Leiden University Medical Center Department of Pediatrics/BMT unit
RECRUITING
Leiden
Princess Máxima Center for Pediatric Oncology
RECRUITING
Utrecht
New Zealand
Starship Children's Hospital
ACTIVE_NOT_RECRUITING
Auckland
Norway
Oslo University Hospital Rikshospitalet
RECRUITING
Oslo
Poland
University Hospital No.1, Collegium Medicum UMK, department of Paediatrics, Oncology, Hematology and Paediatric Transplantology
RECRUITING
Bydgoszcz
University Children's Hospital in Krakow, Department of Transplantation
WITHDRAWN
Krakow
Children's University Hospital, Dept. Pediatric Hematology, Oncology, and Transplantology
NOT_YET_RECRUITING
Lublin
Poznan University of Medical Sciences, Department of Pediatric Onology, Hematology & HSCT
RECRUITING
Poznan
Cape of Hope, Wroclaw Medical University
RECRUITING
Wroclaw
Romania
IInsitutul Clinic Fundeni, Sectia de Transplant Medular
RECRUITING
Bucharest
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
RECRUITING
Timișoara
Saudi Arabia
King Abdullah specialists children hospital
RECRUITING
Riyadh
Slovakia
University Children's Hospital
RECRUITING
Bratislava
Slovenia
University childrens' hospital, UMCL
RECRUITING
Ljubljana
Spain
Hospital Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital Vall d'Hebron
RECRUITING
Barcelona
Hospital Materno Infantil de Málaga
NOT_YET_RECRUITING
Málaga
Hospital Virgen de la Arrixaca
RECRUITING
Murcia
Hospital Universitario Central de Asturias
RECRUITING
Oviedo
Sweden
Queen Silvia Children's Hospital, Department of Pediatric Oncology (Avdelnig 321-322)
RECRUITING
Gothenburg
Skane University Hospital, Dept. of Pediatrics, Section for Hematology and Oncology
RECRUITING
Lund
Karolinska University Hospital, Department of Pediatrics
RECRUITING
Stockholm
University Children's Hospital, Dept. of Women's & Children's Health Section for Pediatrics
RECRUITING
Uppsala
Switzerland
Universitäts-Kinderspital beider Basel (UKBB)
RECRUITING
Basel
HUG Hôpitaux Universitaire de Genève
RECRUITING
Geneva
Universitäts-Kinderspital Zurich
RECRUITING
Zurich
Turkey
Ankara University School of Medicine Pediatric Stem Cell Transplantation Unit
RECRUITING
Ankara
Gazi University School of Medicine Pediatric Stem Cell Transplantation Unit
RECRUITING
Ankara
Gülhane Training and Research Hospital
RECRUITING
Ankara
Akdeniz University School of Medicine Pediatric Stem Cell Transplantation Unit
RECRUITING
Antalya
Bahcesehir University School of Medicine Pediatric Stem Cell Transplantation Unit
RECRUITING
Antalya
Acibadem University Atakent Hospital Pediatric Stem Cell Transplantation Unit
RECRUITING
Istanbul
Bahcelievler Medicalpark Hospital Pediatric Stem Cell Transplantation Unit
RECRUITING
Istanbul
Bahcesehir University School of Medicine Pediatric Stem Cell Transplantation Unit
RECRUITING
Istanbul
Medipol Mega Üniversite Hastanesi
RECRUITING
Istanbul
Dokuzeylul University School of Medicine Pediatric Stem Cell Transplantation Unit
RECRUITING
Izmir
Ege University School of Medicine Pediatric Stem Cell Transplantation Unit
RECRUITING
Izmir
Erciyes University School of Medicine Pediatric Stem Cell Transplantation Unit
RECRUITING
Kayseri
Contact Information
Primary
Christina Peters, Prof. MD PhD
christina.peters@stanna.at
+43140170
Backup
Tijana Frank, MD, MScEng
tijana.frank@ccri.at
+43140470
Time Frame
Start Date: 2013-04
Estimated Completion Date: 2030-04
Participants
Target number of participants: 1800
Treatments
Experimental: Flu/Thio/Treo
Fludarabine/Thiotepa/Treosulfan is used as conditioning regimen for haematopoietic stem cell transplantation (HSCT) in patients with:~* MSD (matched sibling donors) or MD (matched related or unrelated donors). In addition, patients undergoing MD HSCT will receive ATG Thymo- or Grafalon.~* MMD (mismatched donors) with CB (Cord blood) or TCD (T-Cell depletion) or CD34+ selection. In addition, these patients will receive ATG Thymo- or Grafalon.~* MMD (mismatched donors) patients receiving Post TX-Cyclophosphamide
Active_comparator: TBI/VP16
TBI (Total Body Irradiation) / VP16 is used as conditioning regimen for haematopoietic stem cell transplantation (HSCT) in patients older than 48 months with:~* MSD (matched sibling donors) or MD (matched related or unrelated donors). In addition, patients undergoing MD HSCT will receive ATG Thymo- or Grafalon.~* MMD (mismatched donors) with CB (Cord blood) or TCD (T-Cell depletion) or CD34+ selection. In addition, these patients will receive ATG Thymo- or Grafalon.~* MMD (mismatched donors) patients receiving Post TX-Cyclophosphamide.~Patients aged 24-48 months may optionally receive Total Body Irradiation (TBI).
Experimental: Flu/Thio/ivBu
Fludarabine/Thiotepa/iV Busulfan is used as conditioning regimen for haematopoietic stem cell transplantation (HSCT) in patients with:~* MSD (matched sibling donors) or MD (matched related or unrelated donors). In addition, patients undergoing MD HSCT will receive ATG Thymo- or Grafalon.~* MMD (mismatched donors) with CB (Cord blood) or TCD (T-Cell depletion) or CD34+ selection. In addition, these patients will receive ATG Thymo- or Grafalon.~* MMD (mismatched donors) patients receiving Post TX-Cyclophosphamide
Experimental: Bu/VP16/Cy
Busulfan/VP16/Cyclophosphamide is an alternative conditioning arm that may optionally be used for HSCT with MSD/MD and MMD graft in patients aged 0-24 months. Patients undergoing MD HSCT will also receive ATG Thymo- or Grafalon.
Authors
Lars Fischer, Alessandra Biffi, Emel Ozyurek, Justyna Kanold, Manfred Hönig, Alexander Claviez, Jürgen Föll, Oliver Basu, Udo Kontny, Benedicte Bruno, Bernd Gruhn, Silke Kietz, Bernhard Kremens, Fanny Rialland, Wilhelm Wössmann, Selim Corbacioglu, Johann Greil, Johanna Schrum, Charlotte Niemeyer, Dominique Plantaz, Friedhelm Schuster, Ansgar Schulz, Cécile Pochon, Peter Bader, Olga Moser, Paul-Gerhardt Schlegel, Claudia Rössig, Karim Kentouche, Gunnar Cario, Roland Meisel, Holger Christiansen, Peter Lang, Tobias Feuchtinger, Karl-Walter Sykora, Holger Hauch, Pascale Schneider, Brigitte Strahm, Charlotte Jubert, Stefan Schönberger, Laurence Clement, Yves Bertrand, Martin Sauer, Matthias Eyrich, Peter Shaw, Caspar Kühnöl, Hedwig Deubzer, Markus Metzler, Dagmar Dilloo, Birgit Burkhardt, Toralf Bernig, Ingo Müller, Gerard Michel, Catherine Paillard, Joachim Kunz, Michael Albert, Sophie Dupont, Alfred Reiter, Daniel Stachel, Maarten Egeler, Edoardo Lanino, Olga Aleinikova, Johan Arvidson, Jacek Winiarski, Lochie Teague, Gulsun Karasu, Alphan Kupesiz, Vladan Rajic, Angela Wawer, Alina Ferster, Marc Bierings, Gulyuz Ozturk, Karin Mellgren, Stelios Graphakos, Kim Vettenranta, Kirk Schultz, Francoise Mechinaud, Irene Teichert- von Lüttichau, Gergely Krivan, Jean-Pierre Vannier, Savaş Kansoy, Nicolas Von der Weid, Ulker Kocak, Jacek Toporski, Christian Urban, Akif Yesilipek, Marianne Ifversen, Jerry Stein, Sergio M Gomez, Chris Fraser, Volkan Hazar, Jan Soerensen, Veronica Tintori, Franca Fagioli, Marleen Renard, Tunc Fisgin, Orhan Gursel, Victor Lewis, Jörn-Sven Kühl, Marco Rabusin, Anne Sirvent, Tony Truong, Giuseppe Basso, Ronit Elhasid, Jean-Hugues Dalle, Petr Sedlacek, David Mitchell, Virginie Gandemer, Jochen Büchner, Franco Locatelli, Arjan Lankester, Marc Ansari, Henrique Bittencourt, Claudio Favre, Tracey O'Brien, Donna Wall, Davut Albayrak, Jolanta Gozdzik, Musa Karakukcu, Irina Zaidman, Andrea Pession, Carmelo Rizzari, Tommaso Casini, Hale Oren, Concetta Micalizzi
Related Therapeutic Areas
Sponsors
Collaborators: ALL SCTped Forum, Australian & New Zealand Children's Haematology/Oncology Group, Assistance Publique - Hôpitaux de Paris, European Society for Blood and Marrow Transplantation, ALL-BFM Study Group, Swiss Pediatric Oncology Group, Dutch Childhood Oncology Group
Leads: St. Anna Kinderkrebsforschung