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The main purposes of the AIDA protocol are to test the role of intermittent maintenance therapy with ATRA, standard maintenance chemotherapy with methotrexate and 6-mercaptopurine of both in PCR negative patients at the end of the consolidation phase and to evaluate the role of allogeneic or autologous bone marrow transplantation in PCR positive patients at the end of the consolidation phase.
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Ages Eligible for Study:
1 Year to 75 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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