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.
Newly diagnosed APL confirmed by the presence of PML/RARα fusion gene
Age <18 years
Written informed consent by parents or legal guardians
Patients with a clinical diagnosis of APL but subsequently found to lack PML/RARα rearrangement should be withdrawn from the study and treated on an alternative protocol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%)
Parallel
Mylotarg
DrugSee the protocol
Arsenic Trioxide
DrugSee the protocol
All-trans retinoic acid
DrugSee the protocol
Event Free Survival (EFS) probability
SR patients: To evaluate the efficacy in terms of event-free survival of a treatment combining arsenic trioxide (ATO) and all-trans retinoic acid (ATRA) in newly diagnosed APL standard-risk children and adolescents HR patients: To evaluate the efficacy in terms of event-free survival of a treatment combining arsenic trioxide (ATO), all-trans retinoic acid (ATRA) and gemtuzumab ozogamicin (GO) in newly diagnosed APL high-risk children and adolescents
Rate of hematological CR/CRi after induction
To evaluate the rate of hematological Complete Remission (CR) (defined as bone marrow regenerating normal hematopoietic cells and containing \< 5% blast cells by morphology, with ANC in peripheral blood \> 1.0 x 10\^9/L and platelet count \> 100 x 10\^9/L) and Complete Remission with incomplete hematologic recovery (CRi) (defined as CR except that peripheral blood neutrophils and/or platelets do not meet the criteria as defined above) after induction therapy.
Rate of molecular CR/CRi after induction
To evaluate the rate of molecular CR/CRi (defined as the absence of PML/RARα fusion transcript in bone marrow assessed by RQ-PCR, with an assay sensitivity of at least 10\^-4).
Rate of early death during induction
To evaluate the rate of early death during induction (defined as any death occurring within 14 days from diagnosis from any cause).
Probability of overall survival (OS) at 3 years
To evaluate the rate of overall survival
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