Clinical Trials in Spain / NCT04793919
Recruiting
Phase 2
Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia
NCT04793919 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Acute Promyelocytic Leukemia
Investigational drug(s) / intervention(s)
Mylotarg: See the protocol
Arsenic Trioxide: See the protocol
All-trans retinoic acid: See the protocol
Study 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
Inclusion Criteria:
* Newly diagnosed APL confirmed by the presence of PML/RARα fusion gene
* Age \<18 years
* Written informed consent by parents or legal guardians
Exclusion Criteria:
* Patients with a clinical diagnosis of APL but subsequently found to lack PML/RARα rearrangement should be withdrawn from the study and treated on an alternative protocol
* Significant liver dysfunction (bilirubin serum levels \>3 mg/dL, ALT/AST serum levels greater than 5 times the normal values)
* Creatinine serum levels \>2 times the normal value for age
* Significant arrhythmias, EKG abnormalities (\*see below), other cardiac contraindications (L-FEV \<50% or LV-FS \<28%)
* Neuropathy
* Concurrent active malignancy
* Uncontrolled life-threatening infections
* Pregnant or lactating female
* Patients who had received alternative therapy (APL not initially suspected; ATRA and/or ATO not available
Primary outcome measure(s)
- Event Free Survival (EFS) probability — 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
Trial sites (31)
| Facility | City | Region | Status |
|---|---|---|---|
| Hôpital Universitaire des Enfants Reine Fabiola (Huderf) | Brussels | Belgium | Not Yet Recruiting |
| University Hospital Motol | Prague | Czechia | Not Yet Recruiting |
| Pediatrics and Adolescent Medicine Aarhus University Hospital | Aarhus N | Denmark | Not Yet Recruiting |
| CHU de Bordeaux - Hôpital des Enfants | Bordeaux | France | Recruiting |
| Universitätsklinikum Essen (AöR) Zentrum für Kinder-und Jugendmedizin Klinik für Kinderheilkunde III | Essen | Germany | Not Yet Recruiting |
| Our Lady's Children's Hospital Crumlin | Dublin | Ireland | Not Yet Recruiting |
| Rappaport Children'S Hospital, Rambam Health Care Campus | Haifa | Israel | Not Yet Recruiting |
| Ospedale "Casa Sollievo della Sofferenza" - UO Oncoematologia Pediatrica | San Giovanni Rotondo | Foggia | Recruiting |
| AOU Policlinico Dipartimento di Pediatria | Bari | Italy | Not Yet Recruiting |
| Ospedale Papa Giovanni XXIII - USS Oncoematologia Pediatrica | Bergamo | Italy | Not Yet Recruiting |
| AOU Policlinico Sant'Orsola-Malpighi - Oncologia ed Ematologia Pediatrica | Bologna | Italy | Recruiting |
| Ospedale Pediatrico Microcitemico "A.Cau", Az.Ospedaliera Brotzu - SC Oncoematologia Ped. e Patologia della coagulazione | Cagliari | Italy | Recruiting |
| AOU Policlinico Vittorio Emanuele - UOC Ematologia ed Oncologia Pediatrica con TNO | Catania | Italy | Recruiting |
| A.O. Universitaria Meyer - DAI Oncoematologia Pediatrica | Florence | Italy | Not Yet Recruiting |
| IRCCS Istituto Gannina Gaslini - Dipartimento di Oncoematologia | Genova | Italy | Recruiting |
| Fondazione Monza e Brianza per il Bambino e la sua Mamma (MBBM) - Ospedale San Gerardo | Monza | Italy | Recruiting |
| AORN Santobono-Pausilipon | Naples | Italy | Recruiting |
| Univerità degli Studi della Campania- Luigi Vanvitelli - Sevizio di Oncologia Pediatrica | Naples | Italy | Recruiting |
| Azienda Ospedaliera di Padova - Oncoematologia Pediatrica | Padova | Italy | Not Yet Recruiting |
| ARNAS Civico di Cristina e Benfratelli - UOC Oncoematologia Pediatrica | Palermo | Italy | Not Yet Recruiting |
| Fondazione IRCCS Policlinico San Matteo - Oncoematologia Pediatrica | Pavia | Italy | Recruiting |
| Ospedale santa Chiara - AOU Pisana, UO Oncoematologia Pediatrica | Pisa | Italy | Not Yet Recruiting |
| Policlinico Umberto I Università "LA Sapienza" - Dip. Biotecnologie cellulari ed ematologia UOS Ematologia Pediatrica | Roma | Italy | Not Yet Recruiting |
| Dipartimento di Onco-Ematologia e Terapia Cellulare e Genica - Ospedale Pediatrico "Bambino Gesù" | Roma | Italy | Recruiting |
| AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita | Torino | Italy | Recruiting |
| VU medisch centrum | Amsterdam | Netherlands | Not Yet Recruiting |
| Centro Hospitalar Universitário de Coimbra - Hospital Pediátrico de Coimbra | Coimbra | Portugal | Not Yet Recruiting |
| Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE | Lisbon | Portugal | Not Yet Recruiting |
| Instituto Português de Oncologia do Porto Francisco Gentil, E. P. E. | Porto | Portugal | Not Yet Recruiting |
| Valencia University Medical School University Hospital La Fe | Valencia | Spain | Not Yet Recruiting |
| Childrens hematology and oncology Uppsala University | Uppsala | Sweden | Not Yet Recruiting |
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04793919 on ClinicalTrials.gov ↗ ← All trials in Spain