Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia (PETHEMA LPA 2005): Remission Induction With ATRA + Idarubicin. Risk-adapted Consolidation With ATRA and Anthracycline-based Chemotherapy (Idarubicin/Mitoxantrone) With Addition of Ara-C for High-risk Patients. Maintenance Therapy With ATRA + Low Dose Chemotherapy (Methotrexate + Mercaptopurine).
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
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the efficacy and toxicity of a risk-adapted protocol that use idarubicin for induction and consolidation therapy in patients with APL.
San Miguel Miguel Angel, Dr
HOSPITAL LA FE VALENCIA
Spain: Ministry of Health