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

Description

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.

Interventions

• VP16 (Drug)
  60 mg/kg BW,1 day in TBI/VP16 conditioning; 40 mg/kg BW in Bu/VP16/Cy conditioning
• TBI (Radiation)
  2 x 2Gy/day , 3 days (total 12Gy)
• Thiotepa (Drug)
  2x5 mg/kg BW, 1 day
• Treosulfan (Drug)
  14g/m² BS, 3 days
• Fludarabine (Drug)
  30 mg/m² BS, 5 days
• Busulfan (Drug)
  iV, dosage according therapeutic drug monitoring, 4 days
• ATG Thymoglobulin (Drug)
  MD: ATG Thymo: 2,5mg/kg BW/d 3 days.
• Cyclophosphamide (Drug)
  as part of conditioning 60 mg/kg BW 2 days or as GvHD Prophylaxis 50mg/kg BW/d 2 days with Mesna
• Grafalon (Drug)
  MD: 15mg/kg BW/d 3 days MMD: 10mg/kg BW/d 3 days

Eligibility criteria

Conditions

Locations

• Hospital de Pediatria "Juan P. Garrahan" Combate de Los Pozos N°1800 CABA — Buenos Aires, Argentina
• Hospital Sor Maria Ludovica, Department Hematology Stem Cell Transplant Unit — La Plata, Argentina
• Children's Cancer Centre The Royal Children's Hospital — Melbourne, Australia
• Princess Margaret Hospital for Children — Perth, Australia
• Sydney Children's Hospital — Randwick, Australia
• Lady Cilento Children's Hospital — South Brisbane, Australia
• The Children's Hospital at Westmead Oncology Unit — Sydney, Australia
• Universitätsklinik für Kinder- und Jugendheilkunde, Abt. f. Hämato-Onkologie — Graz, Austria
• Universitätsklinik für Kinder- und Jugendheilkunde — Innsbruck, Austria
• St. Anna Children's Hospital, Vienna, Austria — Vienna, Austria
• Belarusian Research Center for Pediatric Oncology, Hematology and Immunology — Minsk, Belarus
• Hôpital Universitaire des Enfants Reine Fabiola (HUDERF) — Brussels, Belgium
• Cliniques Universitaires Saint-Luc (UCL) Hématologie et oncologie pédiatrique — Brussels, Belgium
• University Hospital Gent Pediatrische hemato-oncologie — Ghent, Belgium
• University Hospitals Leuven Kinderhemato-oncologie — Leuven, Belgium
• Centre Hospitalier Universitaire de Liège Domaine Universitaire du Sart Tilman — Liège, Belgium
• Alberta Children's Hospital Division of Pediatric Oncology — Calgary, Canada
• Montreal Children's Hospital — Montral, Canada
• CHU Sainte-Justine Hematology-Oncology Division — Montreal, Canada
• Hospital for Sick Children University of Toronto Division of Haematology/Oncology — Toronto, Canada
• BC Children's Hospital — Vancouver, Canada
• CancerCare Manitoba/University of Manitoba — Winnipeg, Canada
• Hospital Dr Luis Calvo Mackenna — Santiago, Chile
• Department of Pediatrics, UHC Zagreb — Zagreb, Croatia
• Department of Pediatric Hematology and Oncology Teaching Hospital Motol, 2nd Medical School, Charles University — Prague, Czechia
• Paediatric Stem Cell Transplant and Immune Deficiency, Dept. for children and adolescents 4072, Rigshospitalet — Copenhagen, Denmark
• Division of Hematology-Oncology and Stem Cell Transplantation, Hospital for Children and Adolescents, Univ. of Helsinki — Helsinki, Finland
• CHU Bordeaux — Bordeaux, France
• CHU Clermont-Ferrand — Clermont-Ferrand, France
• CHU Grenoble - Clinique Universitaire de Pédiatrie, Hôpital Couple Enfant — Grenoble, France
• CHRU Lille, Service d'Hématologie Pédiatrique — Lille, France
• IHOP / Lyon, Service Hématologie et d'Oncologie pédiatrique — Lyon, France
• Hopital la Timone Adulte — Marseille, France
• Hopital Arnaud de Villeneuve — Montpellier, France
• CHU Nancy - Hopital d'Enfants — Nancy, France
• CHU Nantes, Service d'onco hémato pédiatrie — Nantes, France
• Hôpital Robert Debré — Paris, France
• CHU de Rennes, Serive d'Onco-Pédiatrie — Rennes, France
• CHU de Rouen, Hopital des Enfants, Service d' Immuno-Hématologie Oncologie Pédiatrique — Rouen, France
• CHU Strasbourg, Service d'hématologie et d'oncologie pédiatrique — Strasbourg, France
• Universitätsklinikum Gießen, Zentrum für Kinder- und Jugendmedizin — Giessen, Gießen, Germany
• Uniklinik RWTH Aachen, Kinder- und Jugendmedizin — Aachen, Germany
• Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum — Berlin, Germany
• Universitätsklinikum Bonn, Abteilung für Pädiatrische Hämatologie und Onkologie — Bonn, Germany
• Universitätsklinikum Düsseldorf, Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immunologie — Düsseldorf, Germany
• Universitätsklinikum Erlangen, Kinder- und Jugendklinik — Erlangen, Germany
• Universitätsklinikum Essen, Klinik für Kinderheilkunde III — Essen, Germany
• Klinikum der Johann Wolfgang Goethe-Universität, Klinik für Kinder- und Jugendmedizin (KKJM) — Frankfurt am Main, Germany
• Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin — Freiburg im Breisgau, Germany
• Universitätsmedizin Greifswald, Klinik und Poliklinik für Kinder- und Jugendmedizin — Greifswald, Germany
• Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Kinder- und Jugendmedizin — Halle, Germany
• Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Pädiatrische Hämatologie und Onkologie — Hamburg, Germany
• Medizinische Hochschule Hannover, Zentrum Kinderheilkunde und Jugendmedizin — Hanover, Germany
• Universitätsklinikum Heidelberg, Zentrum für Kinder- und Jugendmedizin — Heidelberg, Germany
• Universitätsklinikum Jena, Sektion für Stammzelltransplantation — Jena, Germany
• UKSH - Universitätsklinikum Schleswig-Holstein, Klinik für Allgemeine Pädiatrie — Kiel, Germany
• Universitätsmedizin Leipzig, Abteilung für Pädiatrische Onkologie, Hämatologie und Hämostaseologie — Leipzig, Germany
• Klinikum der Universität München, Dr. von Haunersches Kinderspital — München, Germany
• Städt. Krankenhaus München Schwabing, Universitätskinderklinik der TU München — München, Germany
• Universitätsklinikum Münster, Klinik für Kinder- und Jugendmedizin — Münster, Germany
• Universitätsklinikum Regensburg, Klinik und Poliklinik für Kinder- und Jugendmedizin — Regensburg, Germany
• Universitätsklinik für Kinder- und Jugendmedizin Tübingen — Tübingen, Germany
• Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin — Ulm, Germany
• Universitäts-Kinderklinik Würzburg — Würzburg, Germany
• Saint Sophia Children's Hospital BMT Unit — Athens, Greece
• National Institute of Haematology and Infectious Disease, Hospital of Southern Pest, Paediatric Bone Marrow Transplantation Unit — Budapest, Hungary
• Rambam Medical Center — Haifa, Israel
• Schneider Children's Medical Center of Israel — Petah Tikva, Israel
• Dana Children's Hospital — Tel Aviv, Israel
• Azienda Ospedaliero-Universitaria Policlinico S. Orsola-Malpighi di Bologna — Bologna, Italy
• Ospedale Mayer di Firenze SODc Tumori Pediatrici e TMO — Florence, Italy
• Istituto Gaslini Genova Oncoematologia Pediatrica- — Genoa, Italy
• A.O. San Gerardo di Monza Clinica Pediatrica — Monza, Italy
• A.O.R.N. Santobono Pausilipon, Dipartimento di Oncoematologia — Naples, Italy
• Azienda Ospedaliera di Padova Oncoematologia Pediatrica — Padova, Italy
• Fondazione IRCCS Policlinico San Matteo — Pavia, Italy
• Azienda Ospedaliero Universitaria Pisana U.O. di Oncoematologia Pediatrica A.O. — Pisa, Italy
• Ospedale Pediatrico Bambino Gesù, Sapienza, University of Rome — Rome, Italy
• Ospedale Infantile Regina Margherita SC Oncoematologia e Centro Trapianti — Torino, Italy
• University of Malaya, Department of Paediatrics — Kuala Lumpur, Malaysia
• Instituto Nacional de Peditria — Mexico City, Mexico
• Leiden University Medical Center Department of Pediatrics/BMT unit — Leiden, Netherlands
• Princess Máxima Center for Pediatric Oncology — Utrecht, Netherlands
• Starship Children's Hospital — Auckland, New Zealand
• Oslo University Hospital Rikshospitalet — Oslo, Norway
• University Hospital No.1, Collegium Medicum UMK, department of Paediatrics, Oncology, Hematology and Paediatric Transplantology — Bydgoszcz, Poland
• University Children's Hospital in Krakow, Department of Transplantation — Krakow, Poland
• Children's University Hospital, Dept. Pediatric Hematology, Oncology, and Transplantology — Lublin, Poland
• Poznan University of Medical Sciences, Department of Pediatric Onology, Hematology & HSCT — Poznan, Poland
• Cape of Hope, Wroclaw Medical University — Wroclaw, Poland
• IInsitutul Clinic Fundeni, Sectia de Transplant Medular — Bucharest, Romania
• 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, Romania
• King Abdullah specialists children hospital — Riyadh, Saudi Arabia
• University Children's Hospital — Bratislava, Slovakia
• University childrens' hospital, UMCL — Ljubljana, Slovenia
• Hospital Santa Creu i Sant Pau — Barcelona, Spain
• Hospital Vall d'Hebron — Barcelona, Spain
• Hospital Materno Infantil de Málaga — Málaga, Spain
• Hospital Virgen de la Arrixaca — Murcia, Spain
• Hospital Universitario Central de Asturias — Oviedo, Spain
• Queen Silvia Children's Hospital, Department of Pediatric Oncology (Avdelnig 321-322) — Gothenburg, Sweden
• Skane University Hospital, Dept. of Pediatrics, Section for Hematology and Oncology — Lund, Sweden
• Karolinska University Hospital, Department of Pediatrics — Stockholm, Sweden
• University Children's Hospital, Dept. of Women's & Children's Health Section for Pediatrics — Uppsala, Sweden
• Universitäts-Kinderspital beider Basel (UKBB) — Basel, Switzerland
• HUG Hôpitaux Universitaire de Genève — Geneva, Switzerland
• Universitäts-Kinderspital Zurich — Zurich, Switzerland
• Ankara University School of Medicine Pediatric Stem Cell Transplantation Unit — Ankara, Turkey (Türkiye)
• Gazi University School of Medicine Pediatric Stem Cell Transplantation Unit — Ankara, Turkey (Türkiye)
• Gülhane Training and Research Hospital — Ankara, Turkey (Türkiye)
• Akdeniz University School of Medicine Pediatric Stem Cell Transplantation Unit — Antalya, Turkey (Türkiye)
• Bahcesehir University School of Medicine Pediatric Stem Cell Transplantation Unit — Antalya, Turkey (Türkiye)
• Acibadem University Atakent Hospital Pediatric Stem Cell Transplantation Unit — Istanbul, Turkey (Türkiye)
• Bahcelievler Medicalpark Hospital Pediatric Stem Cell Transplantation Unit — Istanbul, Turkey (Türkiye)
• Bahcesehir University School of Medicine Pediatric Stem Cell Transplantation Unit — Istanbul, Turkey (Türkiye)
• Medipol Mega Üniversite Hastanesi — Istanbul, Turkey (Türkiye)
• Dokuzeylul University School of Medicine Pediatric Stem Cell Transplantation Unit — Izmir, Turkey (Türkiye)
• Ege University School of Medicine Pediatric Stem Cell Transplantation Unit — Izmir, Turkey (Türkiye)
• Erciyes University School of Medicine Pediatric Stem Cell Transplantation Unit — Kayseri, Turkey (Türkiye)