Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia (PETHEMA LPA 2005)

Primary objectives * To evaluate the efficacy and toxicity of a risk-adapted protocol that use idarubicin for induction and consolidation therapy in patients with APL. * To evaluate the impact of mitoxantrone reduction on the event-free, disease-free, and overall survival, as well as on the duration of remission and cumulative incidence of relapse in low- and intermediate-risk patients with APL. * To evaluate the impact of the addition of ara-C to idarubicin courses of consolidation for high-risk patients (administered as in the original GIMEMA protocols) on the event-free, disease-free, and overall survival, as well as on the duration of remission and cumulative incidence of relapse. * To evaluate the toxicity of the induction, consolidation, and maintenance chemotherapy in the whole series and in each treatment group in patients with APL. Secondary objectives • To compare all outcomes with those achieved with the PETHEMA LPA99 protocol.

Sex

All

Maximum age

75 Years

Inclusion Criteria:

* Age ≤ 75 years.
* ECOG ≤ 3.
* Morphologic Diagnosis of LPA (FAB M3 or variant M3). Those cases without typical morphology but with PML-RARα reordering also must be including.
* Genetic Diagnosis: t (15; 17) demonstrated by cariotipo conventional, FISH, PML-RARα reordering detected by RT-PCR or a pattern microspeckled demonstrated with antibody anti-PML (positive PGM3). Obvious, it will be had the result of these tests once initiated the treatment on the basis of a suspicion diagnoses morphologic

Exclusion Criteria:

* Age \>75 years (the treatment with this protocol can be considered individually)
* Absence of PML-Rare reordering.
* To have received previously some type of treatment for LPA, including chemotherapy or retinoides. The previous treatment with corticoids, hidroxiurea or leucoaféresis is not reason for exclusion.
* To have received chemotherapy or x-ray for the treatment of a disease vitiates previous.
* Associate Neoplasia.
* Serious psychiatric Disease.
* Seropositividad for VIH.
* Contraindication to receive intensive chemotherapy, specially antraciclinas.
* Sérica Creatinina ≥ 2,5 mg/dL (≥ 250 μmol/l).
* Bilirrubina, fosfatasa alkaline, or GOT \> 3 times the normal limit
* Test of positive pregnancy.

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