Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia
Who is this study for? Child to young adult patients with Acute Promyelocytic Leukemia
Status: Recruiting
Location: See all (30) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The trial is open to all patients with a diagnosis of acute promyelocytic leukemia (APL) who are PCR-positive for the PML-RARα transcript and less than 18 years of age.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: f
View:
• Newly diagnosed APL confirmed by the presence of PML/RARα fusion gene
• Age \<18 years
• Written informed consent by parents or legal guardians
Locations
Other Locations
Belgium
Hôpital Universitaire des Enfants Reine Fabiola (Huderf)
NOT_YET_RECRUITING
Brussels
Denmark
Pediatrics and Adolescent Medicine Aarhus University Hospital
NOT_YET_RECRUITING
Aarhus N
France
CHU de Bordeaux - Hôpital des Enfants
RECRUITING
Bordeaux
Germany
Universitätsklinikum Essen (AöR) Zentrum für Kinder-und Jugendmedizin Klinik für Kinderheilkunde III
NOT_YET_RECRUITING
Essen
Ireland
Our Lady's Children's Hospital Crumlin
NOT_YET_RECRUITING
Dublin
Israel
Rappaport Children'S Hospital, Rambam Health Care Campus
NOT_YET_RECRUITING
Haifa
Italy
AOU Policlinico Dipartimento di Pediatria
NOT_YET_RECRUITING
Bari
Ospedale Papa Giovanni XXIII - USS Oncoematologia Pediatrica
NOT_YET_RECRUITING
Bergamo
AOU Policlinico Sant'Orsola-Malpighi - Oncologia ed Ematologia Pediatrica
RECRUITING
Bologna
Ospedale Pediatrico Microcitemico A.Cau, Az.Ospedaliera Brotzu - SC Oncoematologia Ped. e Patologia della coagulazione
RECRUITING
Cagliari
AOU Policlinico Vittorio Emanuele - UOC Ematologia ed Oncologia Pediatrica con TNO
RECRUITING
Catania
A.O. Universitaria Meyer - DAI Oncoematologia Pediatrica
NOT_YET_RECRUITING
Florence
IRCCS Istituto Gannina Gaslini - Dipartimento di Oncoematologia
RECRUITING
Genova
Fondazione Monza e Brianza per il Bambino e la sua Mamma (MBBM) - Ospedale San Gerardo
RECRUITING
Monza
AORN Santobono-Pausilipon
RECRUITING
Naples
Univerità degli Studi della Campania- Luigi Vanvitelli - Sevizio di Oncologia Pediatrica
RECRUITING
Naples
Azienda Ospedaliera di Padova - Oncoematologia Pediatrica
NOT_YET_RECRUITING
Padova
ARNAS Civico di Cristina e Benfratelli - UOC Oncoematologia Pediatrica
NOT_YET_RECRUITING
Palermo
Fondazione IRCCS Policlinico San Matteo - Oncoematologia Pediatrica
RECRUITING
Pavia
Ospedale santa Chiara - AOU Pisana, UO Oncoematologia Pediatrica
NOT_YET_RECRUITING
Pisa
Dipartimento di Onco-Ematologia e Terapia Cellulare e Genica - Ospedale Pediatrico Bambino Gesù
RECRUITING
Roma
Policlinico Umberto I Università LA Sapienza - Dip. Biotecnologie cellulari ed ematologia UOS Ematologia Pediatrica
NOT_YET_RECRUITING
Roma
Ospedale Casa Sollievo della Sofferenza - UO Oncoematologia Pediatrica
RECRUITING
San Giovanni Rotondo
AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita
RECRUITING
Torino
Netherlands
VU medisch centrum
NOT_YET_RECRUITING
Amsterdam
Portugal
Centro Hospitalar Universitário de Coimbra - Hospital Pediátrico de Coimbra
NOT_YET_RECRUITING
Coimbra
Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE
NOT_YET_RECRUITING
Lisbon
Instituto Português de Oncologia do Porto Francisco Gentil, E. P. E.
NOT_YET_RECRUITING
Porto
Spain
Valencia University Medical School University Hospital La Fe
NOT_YET_RECRUITING
Valencia
Sweden
Childrens hematology and oncology Uppsala University
NOT_YET_RECRUITING
Uppsala
Contact Information
Primary
AIEOP
studiclinici@aieop.org
0039 051 2144667
Time Frame
Start Date: 2019-10-09
Estimated Completion Date: 2027-10-10
Participants
Target number of participants: 89
Treatments
Active_comparator: Standard Risk (SR)
Patient with APL and WBC less than 10x10e9/L at presentation before start treatment
Experimental: High Risk (HR)
Patient with APL, with the highest pre-treatment WBC count equal to or greater than 10x10e9/L at presentation
Related Therapeutic Areas
Sponsors
Leads: Associazione Italiana Ematologia Oncologia Pediatrica