Universitätsklinikum Essen (AöR) Zentrum für Kinder-und Jugendmedizin Klinik für Kinderheilkunde III 45147 Essen (Nordrhein-Westfalen) GermanyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Dirk Reinhardt, Prof Phone: 49-(0)201 1723-3784 E-Mail: Dirk.Reinhardt@uk-essen.de» Ansprechpartner anzeigenHôpital Universitaire des Enfants Reine Fabiola (Huderf) 1020 Brussels BelgiumNoch nicht rekrutierend» Google-Maps Ansprechpartner: Laurence Dedeken, MD Phone: +324772678 E-Mail: laurence.dedeken@huderf.be» Ansprechpartner anzeigenUniversity Hospital Motol 15006 Praga CzechiaNoch nicht rekrutierend» Google-Maps Ansprechpartner: Lucie Sramkova, MD Phone: 22443 6401 Phone (ext.): +420 E-Mail: lucie.sramkova@fnmotol.cz» Ansprechpartner anzeigen
Pediatrics and Adolescent Medicine Aarhus University Hospital 8200 Aarhus N DenmarkNoch nicht rekrutierend» Google-Maps Ansprechpartner: Henrik Hasle, Prof.» Ansprechpartner anzeigenCHU de Bordeaux - Hôpital des Enfants 33076 Bordeaux-Cedex FranceRekrutierend» Google-Maps Ansprechpartner: Stéphane Ducassou, MD PhD Phone: 0557820440 E-Mail: stephane.ducassou@chu-bordeaux.fr
Aurore Capelli Phone: 0557820877 E-Mail: aurore.capelli@chu-bordeaux.fr» Ansprechpartner anzeigenOur Lady's Children's Hospital Crumlin 12 Dublin IrelandNoch nicht rekrutierend» Google-Maps Ansprechpartner: Owen P. Smith, Prof Phone: 003531-4096720 E-Mail: owen.smith@olchc.ie» Ansprechpartner anzeigenRappaport Children'S Hospital, Rambam Health Care Campus Haifa IsraelNoch nicht rekrutierend» Google-Maps Ansprechpartner: NIRA ARAD-COHEN, MD Phone: +972-50-206-1181 E-Mail: n_arad-cohen@rambam.health.gov.il» Ansprechpartner anzeigenOspedale "Casa Sollievo della Sofferenza" - UO Oncoematologia Pediatrica 71013 San Giovanni Rotondo ItalyRekrutierend» Google-Maps Ansprechpartner: Saverio Ladogana, Dr» Ansprechpartner anzeigenAOU Policlinico Dipartimento di Pediatria 70124 Bari ItalyNoch nicht rekrutierend» Google-MapsOspedale Papa Giovanni XXIII - USS Oncoematologia Pediatrica 24100 Bergamo ItalyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Massimo Provenzi, Dr» Ansprechpartner anzeigenAOU Policlinico Sant'Orsola-Malpighi - Oncologia ed Ematologia Pediatrica 40138 Bologna ItalyRekrutierend» Google-Maps Ansprechpartner: Andrea Pession, Prof» Ansprechpartner anzeigenOspedale Pediatrico Microcitemico "A.Cau", Az.Ospedaliera Brotzu - SC Oncoematologia Ped. e Patologia della coagulazione 09121 Cagliari ItalyRekrutierend» Google-Maps Ansprechpartner: Rosamaria Mura, Dr» Ansprechpartner anzeigenAOU Policlinico Vittorio Emanuele - UOC Ematologia ed Oncologia Pediatrica con TNO 95123 Catania ItalyRekrutierend» Google-Maps Ansprechpartner: Luca Lo Nigro, Dr» Ansprechpartner anzeigenA.O. Universitaria Meyer - DAI Oncoematologia Pediatrica 50139 Firenze ItalyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Tommaso Casini, Dr» Ansprechpartner anzeigenIRCCS Istituto Gannina Gaslini - Dipartimento di Oncoematologia 16147 Genova ItalyRekrutierend» Google-Maps Ansprechpartner: Concetta Micalizzi, Dr» Ansprechpartner anzeigenFondazione Monza e Brianza per il Bambino e la sua Mamma (MBBM) - Ospedale San Gerardo 20900 Monza ItalyRekrutierend» Google-Maps Ansprechpartner: Carmelo Rizzari, Dr» Ansprechpartner anzeigenAORN Santobono-Pausilipon 80123 Napoli ItalyRekrutierend» Google-Maps Ansprechpartner: Giuseppe Menna, Dr» Ansprechpartner anzeigenUniverità degli Studi della Campania- Luigi Vanvitelli - Sevizio di Oncologia Pediatrica 80138 Napoli ItalyRekrutierend» Google-Maps Ansprechpartner: Francesca Rossi, Prof» Ansprechpartner anzeigenAzienda Ospedaliera di Padova - Oncoematologia Pediatrica 35128 Padova ItalyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Alessandra Biffi, Prof» Ansprechpartner anzeigenARNAS Civico di Cristina e Benfratelli - UOC Oncoematologia Pediatrica 90127 Palermo ItalyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Paolo D'Angelo, Dr» Ansprechpartner anzeigenFondazione IRCCS Policlinico San Matteo - Oncoematologia Pediatrica 27100 Pavia ItalyRekrutierend» Google-Maps Ansprechpartner: Marco Zecca, Dr» Ansprechpartner anzeigenOspedale santa Chiara - AOU Pisana, UO Oncoematologia Pediatrica 56126 Pisa ItalyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Gabriella Casazza, Dr» Ansprechpartner anzeigenPoliclinico Umberto I Università "LA Sapienza" - Dip. Biotecnologie cellulari ed ematologia UOS Ematologia Pediatrica 00161 Roma ItalyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Anna Maria Testi, Dr» Ansprechpartner anzeigenDipartimento di Onco-Ematologia e Terapia Cellulare e Genica - Ospedale Pediatrico "Bambino Gesù" 00165 Roma ItalyRekrutierend» Google-Maps Ansprechpartner: Valentina Cirillo, Dr» Ansprechpartner anzeigenAOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita 10126 Torino ItalyRekrutierend» Google-Maps Ansprechpartner: Franca Fagioli, Prof» Ansprechpartner anzeigenVU medisch centrum Amsterdam NetherlandsNoch nicht rekrutierend» Google-Maps Ansprechpartner: Gertjan Kasper, Prof. dr.» Ansprechpartner anzeigenCentro Hospitalar Universitário de Coimbra - Hospital Pediátrico de Coimbra 3000-602 Coimbra PortugalNoch nicht rekrutierend» Google-Maps Ansprechpartner: Manuel Brito, Dr.» Ansprechpartner anzeigenInstituto Português de Oncologia de Lisboa Francisco Gentil, EPE 1099-023 Lisbon PortugalNoch nicht rekrutierend» Google-Maps Ansprechpartner: Ximo Duarte, Dr.» Ansprechpartner anzeigenInstituto Português de Oncologia do Porto Francisco Gentil, E. P. E. 4200-072 Porto PortugalNoch nicht rekrutierend» Google-Maps Ansprechpartner: Vítor Costa, Dr.» Ansprechpartner anzeigenValencia University Medical School University Hospital La Fe 46026 Valencia SpainNoch nicht rekrutierend» Google-Maps Ansprechpartner: Miguel A. Sanz, MD E-Mail: domingo_joa@gva.es» Ansprechpartner anzeigenChildrens hematology and oncology Uppsala University .O. Box 256, SE-751 05 Uppsala SwedenNoch nicht rekrutierend» Google-Maps Ansprechpartner: Josefine Palle, MD E-Mail: josefine.palle@akademiska.se» Ansprechpartner anzeigen
1. Event Free Survival (EFS) probability (Time Frame - 3 years): SR patients: To evaluate the efficacy in terms of event-free survival of a treatment combining arsenic trioxide (ATO) and all-trans retinoic acid (ATRA) in newly diagnosed APL standard-risk children and adolescents HR patients: To evaluate the efficacy in terms of event-free survival of a treatment combining arsenic trioxide (ATO), all-trans retinoic acid (ATRA) and gemtuzumab ozogamicin (GO) in newly diagnosed APL high-risk children and adolescents
Secondary outcome:
1. Rate of hematological CR/CRi after induction (Time Frame - 5 years): To evaluate the rate of hematological Complete Remission (CR) (defined as bone marrow regenerating normal hematopoietic cells and containing < 5% blast cells by morphology, with ANC in peripheral blood > 1.0 x 10^9/L and platelet count > 100 x 10^9/L) and Complete Remission with incomplete hematologic recovery (CRi) (defined as CR except that peripheral blood neutrophils and/or platelets do not meet the criteria as defined above) after induction therapy.
2. Rate of molecular CR/CRi after induction (Time Frame - 5 years): To evaluate the rate of molecular CR/CRi (defined as the absence of PML/RARα fusion transcript in bone marrow assessed by RQ-PCR, with an assay sensitivity of at least 10^-4).
3. Rate of early death during induction (Time Frame - 5 years): To evaluate the rate of early death during induction (defined as any death occurring within 14 days from diagnosis from any cause).
4. Probability of overall survival (OS) at 3 years (Time Frame - 3 years): To evaluate the rate of overall survival
5. Cumulative incidence of relapse (CIR) at 3 years (Time Frame - 3 years): To evaluate the cumulative incidence of hematological relapse (defined as reappearance of promyeloblasts/abnormal promyelocytes > 5% in the bone marrow) and molecular relapse (defined as reappearance of PML/RARα fusion transcript in two successive samples taken at least 2 weeks apart in patients previously in molecular remission).
6. Incidence of hematological and non-hematological toxicity (Time Frame - 5 years): Incidence of treatment-related hematological and non-hematological toxicity assessed by CTCAE v4.0
7. Rate of molecular remission after 3 consolidation cycles (Time Frame - 5 years): To evaluate the rate of molecular remission (defined as the absence of PML/RARα fusion transcript in bone marrow assessed by RQ-PCR, with an assay sensitivity of at least 10^-4) after 3 consolidation cycles.
8. Assessment of PML/RARα transcription level reduction during treatment (Time Frame - 5 years): To evaluate the reduction of PML/RARα fusion transcript in bone marrow by means of RQ-PCR during treatment.
9. Pediatric Quality of Life assessment (Time Frame - 5 years): Pediatric Quality of life assessed by PedsQoL questionnaire, in the questionnaire there is a list of things that might be a problem for the child. The minimum value is 0 (never a problem) - maximum value 4 (almost always problem)
10. Total hospitalization days during therapy (Time Frame - 5 years): Number of total hospitalization days during the treatment.