NCT04793919RecruitingPhase 2
Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia
Source: ClinicalTrials.gov · Last updated 15 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 89 (estimated)
- First submitted
- 13 Nov 2019
- Start date
- 9 Oct 2019
- Primary completion date
- 9 Oct 2025
- Lead sponsor
- Associazione Italiana Ematologia Oncologia Pediatrica
- Diseases
- Acute myeloid leukemia, Childhood cancers
- NCT number
- NCT04793919
- EU CT number
- 2024-518669-83-00
- EudraCT number
- 2017-002383-40
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 89
- From 9 Oct 2019 to the primary completion date, 9 Oct 2025
- 69 sites in 12 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent active malignancy
- Patients who had received alternative therapy (APL not initially suspected; ATRA and/or ATO not available
Other illness
- Significant arrhythmias, EKG abnormalities (\*see below), other cardiac contraindications (L-FEV \<50% or LV-FS \<28%)
- Uncontrolled life-threatening infections
Lab values
- 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
Other
- Patients with a clinical diagnosis of APL but subsequently found to lack PML/RARα rearrangement should be withdrawn from the study and treated on an alternative protocol
- Neuropathy
- Pregnant or lactating female
Who the study is looking for
- Newly diagnosed APL confirmed by the presence of PML/RARα fusion gene
- Age \<18 years
- Written informed consent by parents or legal guardians
Age in the registry: - to 18 years · Sex: All · Does not accept healthy volunteers
Sites (69)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Universitaire des Enfants Reine Fabiola (Huderf) Coordinator of this site? Confirm its status | Brussels | Belgium | Not yet recruiting |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Active, not recruiting |
| Fakultni nemocnice v Motole Coordinator of this site? Confirm its status | Prague | Czechia | Active, not recruiting |
| Universitätsklinikum Essen (AöR) Zentrum für Kinder-und Jugendmedizin Klinik für Kinderheilkunde III Coordinator of this site? Confirm its status | Essen | Germany | Not yet recruiting |
| Pediatrics and Adolescent Medicine Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Not yet recruiting |
| Valencia University Medical School University Hospital La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Not yet recruiting |
| Centre Hospitalier Universitaire Amiens Picardie Coordinator of this site? Confirm its status | Amiens Cedex 1 | France | Active, not recruiting |
| Centre Hospitalier Universitaire D'Angers Coordinator of this site? Confirm its status | Angers | France | Active, not recruiting |
| CHU Besancon Coordinator of this site? Confirm its status | Besancon Cedex | France | Active, not recruiting |
| Centre hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Active, not recruiting |
| Centre Hospitalier Régional et Universitaire de Brest Coordinator of this site? Confirm its status | Brest | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Caen Normandie Coordinator of this site? Confirm its status | Caen Cedex 9 | France | Active, not recruiting |
| University Hospital Of Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Dijon Coordinator of this site? Confirm its status | Dijon | France | Active, not recruiting |
| Centre Hospitalier Universitaire Grenoble Alpes Coordinator of this site? Confirm its status | La Tronche | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Active, not recruiting |
| Centre Hospitalier Et Universitaire De Limoges Coordinator of this site? Confirm its status | Limoges Cedex 1 | France | Active, not recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Lyon | France | Active, not recruiting |
| Centre Hospitalier Regional De Marseille Coordinator of this site? Confirm its status | Marseille | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Nantes Coordinator of this site? Confirm its status | Nantes Cedex 1 | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Active, not recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Active, not recruiting |
| Centre Hospitalier Universitaire Reims Coordinator of this site? Confirm its status | Reims | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Rennes Coordinator of this site? Confirm its status | Rennes | France | Active, not recruiting |
| Centre Hospitalier Universitaire Rouen Coordinator of this site? Confirm its status | Rouen Cedex | France | Active, not recruiting |
| Centre Hospitalier Universitaire De La Reunion Coordinator of this site? Confirm its status | Saint-Denis | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Saint Etienne Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Active, not recruiting |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex 2 | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Active, not recruiting |
| Centre Hospitalier Régional Universitaire de Tours Coordinator of this site? Confirm its status | Tours | France | Active, not recruiting |
| CHRU De Nancy Coordinator of this site? Confirm its status | Vandoeuvre Les Nancy Cedex | France | Active, not recruiting |
| Our Lady's Children's Hospital Crumlin Coordinator of this site? Confirm its status | Dublin | Ireland | Not yet recruiting |
| Rappaport Children'S Hospital, Rambam Health Care Campus Coordinator of this site? Confirm its status | Haifa | Israel | Not yet recruiting |
| Azienda Ospedaliero-Universitaria delle Marche Coordinator of this site? Confirm its status | Ancona | Italy | Active, not recruiting |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Active, not recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Active, not recruiting |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Active, not recruiting |
| ARNAS G. Brotzu Coordinator of this site? Confirm its status | Cagliari | Italy | Active, not recruiting |
| Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Coordinator of this site? Confirm its status | Catania | Italy | Active, not recruiting |
| Azienda Ospedaliero Universitaria Renato Dulbecco Coordinator of this site? Confirm its status | Catanzaro | Italy | Active, not recruiting |
| Azienda Ospedaliera-Universitaria Di Cosenza Coordinator of this site? Confirm its status | Cosenza | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria Meyer IRCCS Coordinator of this site? Confirm its status | Florence | Italy | Active, not recruiting |
| IRCCS Istituto Giannina Gaslini Coordinator of this site? Confirm its status | Genoa | Italy | Active, not recruiting |
| Fondazione IRCCS San Gerardo dei Tintori Coordinator of this site? Confirm its status | Monza | Italy | Active, not recruiting |
| Azienda Ospedaliera Santobono Pausilipon Coordinator of this site? Confirm its status | Naples | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli Coordinator of this site? Confirm its status | Naples | Italy | Active, not recruiting |
| Azienda Ospedaliera di Padova Coordinator of this site? Confirm its status | Padova | Italy | Active, not recruiting |
| ARNAS Civico Di Cristina Benfratelli Coordinator of this site? Confirm its status | Palermo | Italy | Active, not recruiting |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Active, not recruiting |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Active, not recruiting |
| Grande Ospedale Metropolitano Bianchi Melacrino Morelli Coordinator of this site? Confirm its status | Reggio Calabria | Italy | Active, not recruiting |
| Azienda Unita Sanitaria Locale Della Romagna Coordinator of this site? Confirm its status | Rimini | Italy | Active, not recruiting |
| Ospedale Pediatrico Bambino Gesù Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Casa Sollievo della Sofferenza Coordinator of this site? Confirm its status | San Giovanni Rotondo | Italy | Active, not recruiting |
| Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo Coordinator of this site? Confirm its status | Trieste | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria Integrata Verona Coordinator of this site? Confirm its status | Verona | Italy | Active, not recruiting |
| Prinses Maxima Centrum voor Kinderoncologie B.V. Coordinator of this site? Confirm its status | Utrecht | Netherlands | Active, not recruiting |
| Centro Hospitalar Universitário de Coimbra - Hospital Pediátrico de Coimbra Coordinator of this site? Confirm its status | Coimbra | Portugal | Not yet recruiting |
| Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE Coordinator of this site? Confirm its status | Lisbon | Portugal | Not yet recruiting |
| Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Not yet recruiting |
| Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen Coordinator of this site? Confirm its status | Gothenburg | Sweden | Recruiting |
| Region Oestergoetland Coordinator of this site? Confirm its status | Linkoping | Sweden | Recruiting |
| Region Skane Skanes Universitetssjukhus Coordinator of this site? Confirm its status | Lund | Sweden | Recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Solna | Sweden | Recruiting |
| Region Vaesterbotten Coordinator of this site? Confirm its status | Umea | Sweden | Recruiting |
| Uppsala University Hospital Coordinator of this site? Confirm its status | Uppsala | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.