Treatment of Acute Promyelocytic Leukemia: Remission Induction With ATRA + Idarubicin (AIDA) Risk Adapted Intensity of Consolidation and Addition of ATRA Maintenance With ATRA + Methotrexate + Mercaptopurine Salvage Therapy for Molecular and Haematological Relapses
All-trans retinoic acid, will be administered by mouth (PO) from the first day at a dose of
45 mg/m²/day, fractionated into 2 doses.
In patients aged < 20 years, the ATRA dose will be reduced to 25 mg/m²/day fractionated into
The treatment with ATRA will continue until a CR is achieved or for a maximum of 90 days in
the case of persistence of atypical promyelocytes in the bone marrow.
Idarubicin, 12 mg/m² on days 2, 4, 6 and 8 of treatment by slow intravenous infusion (20
In patients older than 70 years of age only 3 doses of idarubicin will be given on days 2,
4, and 6.
Prednisone, 0.5 mg/kg/day days 1 to 15. Tranexamic acid, 100 mg/kg/day in continuous
perfusion, if platelets < 50 x 10^9/L or evident clinical-biological signs of coagulopathy.
This treatment will be discontinued if the platelet counts are > 50 x 10^9/L.
Transfusion of platelet concentrates to keep up counts above 30 x 10^9/L during the first 10
days and PRC to maintain hemoglobin levels greater than 9 g/dL.
Prophylactic heparin should not be used.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the efficacy of AIDA with a dose reduction in patients older than 70 years of age in the remission induction of APL
Sanz Miguel Angel, Dr
HOSPITAL LA FE VALENCIA
Spain: Ministry of Health
Pethema LPA-99 protocol