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Brief Title: Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia
Official Title: Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia
Study ID: NCT01949129
Brief 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.
Detailed Description: Acute and late side effects of TBI in combination with other chemotherapeutic are manifold to the growing organism and include severe organ dysfunction/failure due to toxicity. Although transplant associated mortality was reduced after HSCT in the last decade due to better HLA matching, infection prevention and control, the burden of late complications is still a matter of concern. Growth retardation, hormonal dysfunction, sterility and the risk of secondary cancer are the late consequences of TBI in children. However, so far no prospective study has demonstrated similar outcomes in paediatric ALL using chemo-conditioning regimen before HSCT. The reason for that is manifold: only a minority of children with ALL qualifies for allogeneic HSCT as most patients are cured with sole modern chemotherapy approaches. Those with dismal prognosis are treated in HSCT centres offering a care to patients with different diseases. Therefore it is nearly impossible to answer the complex outcome questions in single centres or even in single countries. International cooperation is essential to allow prospective investigation within comparable patient cohorts. The trial was initiated to investigate whether chemotherapy based conditioning could replace TBI in pediatric patients with acute lymphoblastic leukemia (ALL) undergoing allogeneic hematopoietic stem cell transplantation (HSCT). It was registered and approved as a prospective, randomized, controlled, open-label, international, multicenter, phase III, non-inferiority trial. Pediatric patients with acute lymphoblastic leukemia (ALL) aged ≤18 years at diagnosis and 4-21 years at HSCT in complete remission pre-HSCT, and with an HLA-compatible related (MSD) or unrelated donor (MD) were randomly assigned to myeloablative conditioning with fractionated 12 Gy TBI and etoposide versus fludarabine (Flu), thiotepa (Thio), and either busulfan (Bu) or treosulfan (Treo). The decision to use the irradiation-free conditioning or Flu/Thio/Treo or Flu/Thio/ivBu was country specific. Patients aged \< 4 years received irradiation-free conditioning. Patients with a mismatched donor (MMD) were stratified according to the donor's stem cell source (cordblood, haploidentical tx or bone marrow/peripheral blood stem cells). The stopping rule was applied on March 31, 2019 following a suspension of random assignment in December 2018 after the chemoconditioning was proven to be significantly inferior to TBI. As a result, TBI/VP16 conditioning remains the standard for patients older than 4 years with MSD/MD, but the age limit for TBI/VP16-based conditioning may be optionally lowered to 2 years.The use of Flu/Thio/Treo or Flu/Thio/ivBu conditioning in this age group is made at centre level based on individual patient assessment. Alternatively, patients aged 0-2 years may receive Bu/VP16/Cy at the discretion of the treating physician. The MSD/MD randomised patients remain in a follow-up to explore the impact of risk factors on the incidence of Adverse Events of Special Interest (AESIs) and on overall survival and event free survival in the entire MSD/MD cohort. In MMD patients, event free survival (EFS) after HSCT from HLA mismatched donors using mismatched unrelated donors (MMD), mismatched cord blood or HLA haplo-identical family members is observed
Minimum Age: 1 Month
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
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, Gent, , 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
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, , Germany
Universitätsklinikum Gießen, Zentrum für Kinder- und Jugendmedizin, Gießen, , 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, Hannover, , 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, Petach-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, Napoli, , 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, Ciudad de México, , 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, Kraków, , Poland
Children's University Hospital, Dept. Pediatric Hematology, Oncology, and Transplantology, Lublin, , Poland
Poznan University of Medical Sciences, Department of Pediatric Onology, Hematology & HSCT, Poznań, , Poland
Cape of Hope, Wroclaw Medical University, Wrocław, , Poland
IInsitutul Clinic Fundeni, Sectia de Transplant Medular, Bukarest, , 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, Timişoara, , 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 Virgen de la Arrixaca, Murcia, , Spain
Hospital Materno Infantil de Málaga, Málaga, , Spain
Hospital Universitario Central de Asturias, Oviedo, , Spain
Queen Silvia Children's Hospital, Department of Pediatric Oncology (Avdelnig 321-322), Göteborg, , 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
Gazi University School of Medicine Pediatric Stem Cell Transplantation Unit, Ankara, , Turkey
Gülhane Training and Research Hospital, Ankara, , Turkey
Akdeniz University School of Medicine Pediatric Stem Cell Transplantation Unit, Antalya, , Turkey
Bahcesehir University School of Medicine Pediatric Stem Cell Transplantation Unit, Antalya, , Turkey
Acibadem University Atakent Hospital Pediatric Stem Cell Transplantation Unit, Istanbul, , Turkey
Bahcelievler Medicalpark Hospital Pediatric Stem Cell Transplantation Unit, Istanbul, , Turkey
Bahcesehir University School of Medicine Pediatric Stem Cell Transplantation Unit, Istanbul, , Turkey
Medipol Mega Üniversite Hastanesi, Istanbul, , Turkey
Dokuzeylul University School of Medicine Pediatric Stem Cell Transplantation Unit, Izmir, , Turkey
Ege University School of Medicine Pediatric Stem Cell Transplantation Unit, Izmir, , Turkey
Erciyes University School of Medicine Pediatric Stem Cell Transplantation Unit, Kayseri, , Turkey
Name: Christina Peters, Prof. MD PhD
Affiliation: St. Anna Kinderspital, Vienna, Austria
Role: STUDY_CHAIR
Name: Peter Bader, Prof. MD PhD
Affiliation: Goethe University
Role: STUDY_CHAIR
Name: Franco Locatelli, Prof. MD PhD
Affiliation: Ospedale Pediatrico Bambino Gesù, Rome, Italy
Role: STUDY_CHAIR