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← Trials
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Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia

RecruitingPhase 2Ages any - 18 YearsAllAssociazione Italiana Ematologia Oncologia Pediat…
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Newly diagnosed APL confirmed by the presence of PML/RARα fusion gene * Age \<18 years * Written informed consent by parents or legal guardians Exclusion Criteria: * Patients with a clinical diagnosis of APL but subsequently found to lack PML/RARα rearrangement should be withdrawn from the study and treated on an alternative protocol * Significant liver dysfunction (bilirubin serum levels \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
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What it tests

  • Mylotarg
  • Arsenic Trioxide
  • All-trans retinoic acid
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Where

31 sites
Hôpital Universitaire des Enfants Reine Fabiola (Huderf)
Brussels, Belgium
University Hospital Motol
Prague, Czechia
Pediatrics and Adolescent Medicine Aarhus University Hospital
Aarhus N, Denmark
CHU de Bordeaux - Hôpital des Enfants
Bordeaux, France
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
Ospedale "Casa Sollievo della Sofferenza" - UO Oncoematologia Pediatrica
San Giovanni Rotondo, Italy

…and 23 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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