- Age 18-75 years
- ECOG performance status ≤ 3.
- Morphological diagnosis of APL (FAB-M3 or M3 variant). Those cases without typical morphology but with PML-RARa rearrangement should also be included.
- Genetic diagnosis: t(15;17) demonstrated by conventional karyotyping, PML-RARa rearrangement detected by RT-PCR or FISH, microspeckled PML protein pattern demonstrated by PG-M3 monoclonal antibody. Obviously, the result of these tests may become available after having initiated the treatment based on a tentative morphological diagnosis.
- Age >75 years (the treatment with this protocol can be considered on an individual basis)
- Absence of PML-RARa rearrangement.
- The patient must not have received any systemic definitive treatment for APL, including cytotoxic chemotherapy or retinoids. Prior therapy with corticosteroids, hydroxiurea or leukapheresis will not exclude the patient.
- Prior chemotherapy or radiotherapy for the treatment of prior malignancy.
- Presence of an associated neoplasm.
- Presence of a severe psychiatric disease.
- HIV seropositivity.
- Contraindication for intensive chemotherapy, especially to anthracyclines.
- Serum creatinine ≥ 250 μmol/l (≥ 2.5 mg/dL)
- Bilirubin, alkaline phosphatase, or SGOT > 3 times the upper normal limit
- Positive pregnancy test.
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