It is a non-randomized, multicenter, prospective study, aiming to treat patients with newly diagnosed acute promyelocytic leukemia with a combination of oral arsenic and atra, with low dose chemotherapy for those with high-risk disease (white blood cell count above 10x10a9/L). The primary objective is to assess the 2-year overall survival (OS) in these patients, comparing with the historical control group of patients treated with ATRA/chemotherapy according to the IC-APL 2006 protocol.
Informed consent
New diagnosis of APL by cytomorphology, confirmed for molecular analysis
Age ≥18 and ≤75 years
Serum total bilirubin ≤ 3.0 mg/dl (≤ 51 μmol/l)
High-risk patients who are not eligible for chemotherapy according to the judgment of the treating physician;
Age <18 or >75 years
Other active malignancy at the time of study entry
Lack of diagnostic confirmation at the genetic level
Instituto do Cancer do Estado de São Paulo
Lead sponsor
American Society of Hematology
Collaborator