Tests Mylotarg, arsenic trioxide and retinoic acid in children with acute promyelocytic leukemia
Tests Mylotarg, arsenic trioxide and retinoic acid in young people with promyelocytic leukemia.
Plain-language title generated from the registry record
Registry title: Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia
Key facts
- Where
- Brno and Prague, CzechiaSee the 2 sites
- Phase
- Phase 2
Where in Czechia
- Fakultni nemocnice BrnoBrno, CzechiaNo longer taking part
- Fakultni nemocnice v MotolePrague, CzechiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Associazione Italiana Ematologia Oncologia Pediatrica
- Trial code
- NCT04793919EU 2024-518669-83-00
- Record updated
- 15 April 2024
- Original description
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.Read full original descriptionShow less
Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia
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.
Inclusion: Newly diagnosed APL confirmed by the presence of PML/RARα fusion gene; Age <18 years; Written informed consent by parents or legal guardians.
Exclusion: Concurrent active malignancy; Patients who had received alternative therapy (APL not initially suspected; ATRA and/or ATO not available; Significant arrhythmias, EKG abnormalities (*see below), other cardiac contraindications (L-FEV <50% or LV-FS <28%); Uncontrolled life-threatening infections; 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for age; Patients with a clinical diagnosis of APL but subsequently found to lack PML/RARα rearrangement should be withdrawn from the study and treated on an alternative protocol; Neuropathy; Pregnant or lactating female.