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
- Dublin, IrelandSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teenagers under 18 with newly diagnosed acute promyelocytic leukemia (APL) that carries the PML/RARα fusion gene.
- Age
- Under 18 years.
- Sex
- Boys and girls can both join.
- Disease stage
- Newly diagnosed acute promyelocytic leukemia (APL).
- Earlier treatment
- People who already had other treatment, because APL was not suspected at first or ATRA and/or ATO were not available, cannot join.
- Biomarker or test result
- The PML/RARα fusion gene must be present.
Main reasons for not taking part
- Clinical APL without the PML/RARα rearrangement
- Significant liver problems (bilirubin above 3 mg/dL, ALT/AST more than 5 times normal)
- Creatinine more than 2 times the normal value for age
- Significant heart rhythm or heart function problems (L-FEV below 50% or LV-FS below 28%)
- Another active cancer, neuropathy, or uncontrolled life-threatening infection
Read by machine on 9 November 2026.
Where in Ireland
- Our Lady's Children's Hospital CrumlinDublin, IrelandNot yet recruiting
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.