Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia
Recruiting now · Phase 2
Conditions studied: Acute Promyelocytic Leukemia
In brief
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.
Key facts
- Study ID
- NCT04793919
- Run by
- Associazione Italiana Ematologia Oncologia Pediatrica
- People needed
- 89
- Starts
- 2019-10-09
- Expected to finish
- 2027-10-10
- Last updated by the study team
- 2024-04-15
Who can join
Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Newly diagnosed APL confirmed by the presence of PML/RARα fusion gene
- Age <18 years
- Written informed consent by parents or legal guardians
You may not qualify if…
- Patients with a clinical diagnosis of APL but subsequently found to lack PML/RARα rearrangement should be withdrawn from the study and treated on an alternative protocol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
Where it is running
- AOU Policlinico Sant'Orsola-Malpighi - Oncologia ed Ematologia Pediatrica — Bologna, Italy (enrolling)
- Fondazione IRCCS Policlinico San Matteo - Oncoematologia Pediatrica — Pavia, Italy (enrolling)
- Ospedale Pediatrico Microcitemico "A.Cau", Az.Ospedaliera Brotzu - SC Oncoematologia Ped. e Patologia della coagulazione — Cagliari, Italy (enrolling)
- AOU Policlinico Vittorio Emanuele - UOC Ematologia ed Oncologia Pediatrica con TNO — Catania, Italy (enrolling)
- Dipartimento di Onco-Ematologia e Terapia Cellulare e Genica - Ospedale Pediatrico "Bambino Gesù" — Roma, Italy (enrolling)
- AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita — Torino, Italy (enrolling)
- CHU de Bordeaux - Hôpital des Enfants — Bordeaux, France (enrolling)
- IRCCS Istituto Gannina Gaslini - Dipartimento di Oncoematologia — Genova, Italy (enrolling)
- Fondazione Monza e Brianza per il Bambino e la sua Mamma (MBBM) - Ospedale San Gerardo — Monza, Italy (enrolling)
- AORN Santobono-Pausilipon — Naples, Italy (enrolling)
- Univerità degli Studi della Campania- Luigi Vanvitelli - Sevizio di Oncologia Pediatrica — Naples, Italy (enrolling)
- Ospedale "Casa Sollievo della Sofferenza" - UO Oncoematologia Pediatrica — San Giovanni Rotondo, Foggia, Italy (enrolling)
- Policlinico Umberto I Università "LA Sapienza" - Dip. Biotecnologie cellulari ed ematologia UOS Ematologia Pediatrica — Roma, 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
- Hôpital Universitaire des Enfants Reine Fabiola (Huderf) — Brussels, Belgium
- Childrens hematology and oncology Uppsala University — Uppsala, Sweden
- University Hospital Motol — Prague, Czechia
- Pediatrics and Adolescent Medicine Aarhus University Hospital — Aarhus N, Denmark
- 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
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.