Acute Lymphoblastic Leukaemia Clinical Trial
Official title:
Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia
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.
Status | Recruiting |
Enrollment | 1800 |
Est. completion date | April 2030 |
Est. primary completion date | June 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Month to 18 Years |
Eligibility | Inclusion Criteria: 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 Exclusion Criteria: - patients who do not fulfil the inclusion criteria - Non Hodgkin-Lymphoma - the whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian - no consent is given for saving and propagation of anonymous medical data for study reasons - severe concomitant disease that does not allow treatment according to the protocol at the investigator's discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders) - Karnofsky / Lansky score < 50% - subjects unwilling or unable to comply with the study procedures |
Country | Name | City | State |
---|---|---|---|
Argentina | 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 | |
Australia | 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 | |
Austria | 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 | |
Belarus | Belarusian Research Center for Pediatric Oncology, Hematology and Immunology | Minsk | |
Belgium | Cliniques Universitaires Saint-Luc (UCL) Hématologie et oncologie pédiatrique | Brussels | |
Belgium | Hôpital Universitaire des Enfants Reine Fabiola (HUDERF) | 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 | |
Canada | 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 | |
Chile | Hospital Dr Luis Calvo Mackenna | Santiago | |
Croatia | Department of Pediatrics, UHC Zagreb | Zagreb | |
Czechia | Department of Pediatric Hematology and Oncology Teaching Hospital Motol, 2nd Medical School, Charles University | Prague | |
Denmark | Paediatric Stem Cell Transplant and Immune Deficiency, Dept. for children and adolescents 4072, Rigshospitalet | Copenhagen | |
Finland | Division of Hematology-Oncology and Stem Cell Transplantation, Hospital for Children and Adolescents, Univ. of Helsinki | Helsinki | |
France | 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 | |
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 | |
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 | |
Greece | Saint Sophia Children's Hospital BMT Unit | Athens | |
Hungary | National Institute of Haematology and Infectious Disease, Hospital of Southern Pest, Paediatric Bone Marrow Transplantation Unit | Budapest | |
Israel | Rambam Medical Center | Haifa | |
Israel | Schneider Children's Medical Center of Israel | Petach-Tikva | |
Israel | Dana Children's Hospital | Tel Aviv | |
Italy | 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 | |
Malaysia | University of Malaya, Department of Paediatrics | Kuala Lumpur | |
Mexico | Instituto Nacional de Peditria | Ciudad de México | |
Netherlands | Leiden University Medical Center Department of Pediatrics/BMT unit | Leiden | |
Netherlands | Princess Máxima Center for Pediatric Oncology | Utrecht | |
New Zealand | Starship Children's Hospital | Auckland | |
Norway | Oslo University Hospital Rikshospitalet | Oslo | |
Poland | 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 | Poznan | |
Poland | Cape of Hope, Wroclaw Medical University | Wroclaw | |
Romania | 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 | Timisoara | |
Saudi Arabia | King Abdullah specialists children hospital | Riyadh | |
Slovakia | University Children's Hospital | Bratislava | |
Slovenia | University childrens' hospital, UMCL | Ljubljana | |
Spain | 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 | |
Sweden | 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 | |
Switzerland | Universitäts-Kinderspital beider Basel (UKBB) | Basel | |
Switzerland | HUG Hôpitaux Universitaire de Genève | Geneva | |
Switzerland | Universitäts-Kinderspital Zurich | Zurich | |
Turkey | 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 |
Lead Sponsor | Collaborator |
---|---|
St. Anna Kinderkrebsforschung | ALL SCTped Forum, ALL-BFM Study Group, Assistance Publique - Hôpitaux de Paris, Australian & New Zealand Children's Haematology/Oncology Group, Dutch Childhood Oncology Group, European Society for Blood and Marrow Transplantation, Swiss Pediatric Oncology Group |
Argentina, Australia, Austria, Belarus, Belgium, Canada, Chile, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Romania, Saudi Arabia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Acute Graft versus Host Disease (aGVHD) | According to the modified Seattle Glucksberg criteria | first: 18 months after inclusion of first patient, afterwards annually up to 10 years | |
Other | Secondary malignancies | Incidence, type and timepoint of occurence | first: 18 months after inclusion of first patient, afterwards annually up to 10 years | |
Other | Chronic Graft-versus-host disease (cGvHD) | Chronic GVHD is diagnosed using criteria created through the NIH consensus development project | first: 18 months after inclusion of first patient, afterwards annually up to 10 years | |
Primary | Overall Survival (OS) Stratum 1a (randomisation TBI+ chemo-conditioning vs. chemo-conditioning only) | Stratum 1 - randomisation related question was closed in December 2018; patients are in active follow-up: To show that a non total body irradiation (TBI) containing conditioning (Flu/Thio/ivBu or Flu/Thio/Treo) results in a non-inferior survival as compared to conditioning with TBI/Etoposide in children older than 4 years after HSCT from a Human leucocyte antigen (HLA) identical sibling donor (MSD) or a HLA matched donor (MD). The primary endpoint is the OS calculated from the date of the randomisation. Death from any cause will be considered an event. | first: 18 months after inclusion of first patient, afterwards annually up to 10 years | |
Primary | Event free survival (EFS) Stratum 2 (mismatched donor transplantation) | EFS after allogeneic HSCT. EFS calculated from date of recruitment to disease progression or relapse, secondary neoplasm and death from any cause. | first: 18 months after inclusion of first patient, afterwards annually up to 10 years | |
Primary | Overall Survival (OS), Stratum 1b: MSD/MD without randomisation | 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 | first: 18 months after inclusion of first patient, afterwards annually up to 10 years | |
Secondary | EFS (Stratum 1a and 1b) | EFS calculated from date of randomization (1a) or recruitment (1b) to disease progression or relapse, secondary neoplasm and death from any cause. Patients lost to follow-up without event will be censored at the date of their last follow-up evaluation. | first: 18 months after inclusion of first patient, afterwards annually up to 10 years | |
Secondary | TRM | Cumulative Incidence of Treatment-related mortality (TRM) for Stratum 1 and 2. | first: 18 months after inclusion of first patient, afterwards annually up to 10 years | |
Secondary | Relapse/progression | Cumulative Incidence of Relapse for Stratum 1a, 1b and 2. | first: 18 months after inclusion of first patient, afterwards annually up to 10 years | |
Secondary | Acute and late toxicity for Stratum 1a, 1b and 2 | according a preselection out of CTC3 | first: 18 months after inclusion of first patient, afterwards annually up to 10 years | |
Secondary | OS (Stratum 2) | The primary endpoint is the OS calculated from the date of the recruitment . Death from any cause will be considered an event. | first: 18 months after inclusion of first patient, afterwards annually up to 10 years |
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