AIDA 2000 Guidelines

Inclusion Criteria:

• Age >= 1 years and < 61 years

• Morphologic diagnosis of APL

• PS <= 3

• Presence in leukemic cells at diagnosis of t(15;17), and/or PML/RARa rearrangement byRT-PCR. T

• The presence of additional cytogenetic lesions is not considered an exclusioncriterion

• Serum creatinine <=2.5 mg/dL

• Serum bilirubin, alkaline phosphatase, or GOT/ASAT <= 3 times the upper normal limit

• Negative pregnancy test

• Written informed consent

Exclusion Criteria:

• Age >= 61 years

• Prior antileukemic chemotherapy for APL

• Absence of PML-RARa rearrangement after successful RNA extraction and amplification ofcontrol gene

• Prior antileikemic chemotherapy for APL

• Presence of a concomitant malignant neoplasm, except basal cell carcinoma Concurrenttreatment with cytotoxic chemotherapy or radiotherapy

• Oteher progressive malignant disease. However, secondary acute promyelocytic leukemiafollowing "cured" Hodgkin's disease or otehr cured malignancies may be included, aswell as secondary leukemias following other exposure to alkylating agents or radiationfor other reasons