Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia

NCT04793919 · tracked via the Priya Life Science Italy tracker

Sponsor

Associazione Italiana Ematologia Oncologia Pediatrica

Phase

Phase 2

Started

2019-10-09

Last updated

2024-04-15

Condition(s) studied

Acute Promyelocytic Leukemia

Investigational drug(s) / intervention(s)

Mylotarg →Arsenic Trioxide →All-trans retinoic acid →

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

Sex

ALL

Min age

—

Max age

18 Years

Healthy volunteers

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Criteria: * Patients with a clinical diagnosis of APL but subsequently found to lack PML/RARα rearrangement should be withdrawn from the study and treated on an alternative protocol * Significant liver dysfunction (bilirubin serum levels \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

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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 Italy