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Taking peoplePhase 2

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.

Key facts

Who runs it
Associazione Italiana Ematologia Oncologia Pediatrica
Where
Dublin, IrelandSee the siteAlso in 11 other countries, 68 sites
Registry title
Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia
Status
Recruiting
Phase
Phase 2
People taking part
89 people, planned
Started
9 Oct 2019
Expected to end
10 Oct 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Mylotarg
  • Arsenic Trioxide
  • All-trans retinoic acid
Record updated
15 April 2024

Who can take part

AI summary

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

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • Newly diagnosed APL confirmed by the presence of PML/RARα fusion gene
  • Age <18 years
  • Written informed consent by parents or legal guardians

Who cannot take part

  • 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

Where in Ireland

Also in 11 other countries, 68 sites

  • Our Lady's Children's Hospital CrumlinDublin, IrelandContact: Owen P. Smith, ProfNot yet recruiting

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Standard Risk (SR)Existing treatment, for comparison

    Patient with APL and WBC less than 10x10e9/L at presentation before start treatment

    Treatment: Arsenic Trioxide and All-trans retinoic acid

  • High Risk (HR)Treatment being tested

    Patient with APL, with the highest pre-treatment WBC count equal to or greater than 10x10e9/L at presentation

    Treatment: Mylotarg, Arsenic Trioxide, and All-trans retinoic acid

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia
Plain-language title
Tests Mylotarg, arsenic trioxide and retinoic acid in children with acute promyelocytic leukemiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
15 April 2024