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Spots Global Cancer Trial Database for Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia

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Trial Identification

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

Study Description

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

Eligibility

Minimum Age: 1 Month

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

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, 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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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