"AIDA" Protocol (LAP 0493)

Inclusion Criteria:

• Age > 12 months (1 year) and < 75 years

• Morphological newly diagnosis of APL

• Presence of the PML-RARa transcript

• No cardiac contraindications to anthracycline chemotherapy

• Serum creatinine <=2.5 mg/dL

• Serum alkaline phosphatase <= 3 times the normal upper limit

• Serum bilirubin <= 3 times the normal upper limit

• Serum SGOT <= 3 times the upper normal limit

• Negative pregnancy test

• Informed consent

Exclusion Criteria:

• Age <= 12 months and >=75 years

• absence of the PML-RARa transcript

• Pregnant of lactating women

• Presence of active serious infections that are not controlled by antibiotics

• Prior treatment with antileukemic therapy (excluded corticosteroids)

• Presence of severe concomitant psychiatric disease

• Presence of other concomitant malignant tumors, except basal cell carcinoma

• Concurrent treatment with cytotoxic chemotherapy or radiotherapy

• Cardiac contraindications to anthracycline chemotherapy

• Serum creatinine >2.5 mg/dL

• Serum alkaline phosphatase > 3 times the normal upper limit

• Serum bilirubin > 3 times the normal upper limit

• Serum SGOT > 3 times the upper normal limit

• Positive pregnancy test

• Absence of informed consent