RecruitingPhase 2NCT04793919

Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia


Sponsor

Associazione Italiana Ematologia Oncologia Pediatrica

Enrollment

89 participants

Start Date

Oct 9, 2019

Study Type

INTERVENTIONAL

Conditions

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

Max Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at optimal treatment for children and adolescents with acute promyelocytic leukemia (APL), a specific and potentially curable type of blood cancer. APL is identified by a specific genetic change (the PML/RARα fusion gene). Researchers are tracking outcomes of children treated under a standardized protocol. **You may be eligible if...** - You are under 18 years old - You have a newly confirmed diagnosis of APL with the PML/RARα genetic marker - A parent or legal guardian has given written consent **You may NOT be eligible if...** - Your APL diagnosis is not confirmed by the required genetic test (PML/RARα) - You have significant liver, kidney, or heart problems - You have already started treatment elsewhere Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMylotarg

See the protocol

DRUGArsenic Trioxide

See the protocol

DRUGAll-trans retinoic acid

See the protocol


Locations(31)

Hôpital Universitaire des Enfants Reine Fabiola (Huderf)

Brussels, Belgium

University Hospital Motol

Prague, Czechia

Pediatrics and Adolescent Medicine Aarhus University Hospital

Aarhus N, Denmark

CHU de Bordeaux - Hôpital des Enfants

Bordeaux, France

Universitätsklinikum Essen (AöR) Zentrum für Kinder-und Jugendmedizin Klinik für Kinderheilkunde III

Essen, Germany

Our Lady's Children's Hospital Crumlin

Dublin, Ireland

Rappaport Children'S Hospital, Rambam Health Care Campus

Haifa, Israel

Ospedale "Casa Sollievo della Sofferenza" - UO Oncoematologia Pediatrica

San Giovanni Rotondo, Foggia, Italy

AOU Policlinico Dipartimento di Pediatria

Bari, Italy

Ospedale Papa Giovanni XXIII - USS Oncoematologia Pediatrica

Bergamo, Italy

AOU Policlinico Sant'Orsola-Malpighi - Oncologia ed Ematologia Pediatrica

Bologna, Italy

Ospedale Pediatrico Microcitemico "A.Cau", Az.Ospedaliera Brotzu - SC Oncoematologia Ped. e Patologia della coagulazione

Cagliari, Italy

AOU Policlinico Vittorio Emanuele - UOC Ematologia ed Oncologia Pediatrica con TNO

Catania, Italy

A.O. Universitaria Meyer - DAI Oncoematologia Pediatrica

Florence, Italy

IRCCS Istituto Gannina Gaslini - Dipartimento di Oncoematologia

Genova, Italy

Fondazione Monza e Brianza per il Bambino e la sua Mamma (MBBM) - Ospedale San Gerardo

Monza, Italy

AORN Santobono-Pausilipon

Naples, Italy

Univerità degli Studi della Campania- Luigi Vanvitelli - Sevizio di Oncologia Pediatrica

Naples, Italy

Azienda Ospedaliera di Padova - Oncoematologia Pediatrica

Padova, Italy

ARNAS Civico di Cristina e Benfratelli - UOC Oncoematologia Pediatrica

Palermo, Italy

Fondazione IRCCS Policlinico San Matteo - Oncoematologia Pediatrica

Pavia, Italy

Ospedale santa Chiara - AOU Pisana, UO Oncoematologia Pediatrica

Pisa, Italy

Policlinico Umberto I Università "LA Sapienza" - Dip. Biotecnologie cellulari ed ematologia UOS Ematologia Pediatrica

Roma, Italy

Dipartimento di Onco-Ematologia e Terapia Cellulare e Genica - Ospedale Pediatrico "Bambino Gesù"

Roma, Italy

AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita

Torino, Italy

VU medisch centrum

Amsterdam, Netherlands

Centro Hospitalar Universitário de Coimbra - Hospital Pediátrico de Coimbra

Coimbra, Portugal

Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE

Lisbon, Portugal

Instituto Português de Oncologia do Porto Francisco Gentil, E. P. E.

Porto, Portugal

Valencia University Medical School University Hospital La Fe

Valencia, Spain

Childrens hematology and oncology Uppsala University

Uppsala, Sweden

View Full Details on ClinicalTrials.gov

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NCT04793919


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