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
Single group
Realgar-Indigo Naturalis Formulation
DrugOral Arsenic (Realgar-Indigo Naturalis Formulation) plus ATRA for low-intermediate risk APL pts, combined with daunorubicin for high-risk during induction
Overall Survival
This endpoint includes death from any cause, including early death, death due to disease progression, or any death occurring after achieving complete remission.
Complete hematologic response rate after induction.
Absence of leukemic promyelocytes in the peripheral blood and bone marrow (\<5% blasts), recovery of normal blood counts (ANC ≥ 1.0 × 10⁹/L and platelets ≥ 100 × 10⁹/L), no extramedullary disease, and resolution of coagulopathy.
Early death rate during induction
Death before blood cell counts recovery during induction.
Disease-free survival rate
The proportion of patients who remain alive and in complete remission, without evidence of relapse, for at least two years following achievement of initial complete remission.
Cumulative incidence of myelodysplasia and secondary leukemia
The proportion of patients who develop myelodysplastic syndromes or secondary leukemia after treatment.
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Instituto do Cancer do Estado de São Paulo
Lead sponsor
American Society of Hematology
Collaborator
