treatment of newly diagnosed patients with acute promyelocytic leukemia (pethema lpa 2005)

Conditions: Acute Promyelocytic Leukemia

Summary: 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.

treatment of induction with the simultaneous administration of atra (45 mg/m2 day until the rc) and idarubicine (12 mg/m2 days 2, 4, 6 and 8), 3 monthly cycles of consolidation with atra (45 mg/m2 days 1-15) and idarubicine (5 mg/m2 days 1-4) in the cycle #1, mitoxantrone (10 mg/m2 days 1-3) in the cycle #2 and idarubicine (12 mg/m2 day 1) in the cycle #3. the consolidation was reinforced for the group of patients with intermediate risk by means of an increase of the idarubicine to 7 mg in the cycle #1 and to 2 days in the cycle #3. in the patients of high risk, the consolidation was reinforced with the addition of altar-c in the cycles #1 and #3. for the maintenance treatment, one will administer to intermittent atra (15 days every 3 months) and chemotherapy low doses with methotrexate and 6-mercaptopurina during two years

Eligibility criteria:
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.

Keywords: acute promyelocytic leukemia