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.
This is a non-randomized, multicenter, prospective study aimed at treating patients with newly diagnosed acute promyelocytic leukemia (APL) using a combination of oral arsenic and ATRA. For patients classified as high-risk (white blood cell count \>10×10⁹/L), low-dose chemotherapy will be added. The primary objective is to evaluate the 2-year overall survival (OS) in these patients, comparing it to a historical control group treated with ATRA and chemotherapy according to the IC-APL 2006 protocol. Secondary objectives include: Comparing complete response rates, disease-free survival, cumulative incidence of relapse, and early mortality with those reported in the IC-APL 2006 study (historical controls), as well as with outcomes reported in developed countries; Comparing the cumulative incidence of myelodysplasia or secondary leukemia; Comparing the toxicity profile with historical data; Assessing the molecular remission rate after consolidation; Evaluating the reduction in PML/RARA transcript levels during treatment; Comparing the duration of patient hospitalization with historical results.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
115
Oral Arsenic (Realgar-Indigo Naturalis Formulation) plus ATRA for low-intermediate risk APL pts, combined with daunorubicin for high-risk during induction
Instituto do Cancer do Estado de Sao Paulo
São Paulo, São Paulo, Brazil
RECRUITINGOverall Survival
This endpoint includes death from any cause, including early death, death due to disease progression, or any death occurring after achieving complete remission.
Time frame: 2 years
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.
Time frame: 30 days
Early death rate during induction
Death before blood cell counts recovery during induction.
Time frame: 30 days
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.
Time frame: 2 years
Cumulative incidence of myelodysplasia and secondary leukemia
The proportion of patients who develop myelodysplastic syndromes or secondary leukemia after treatment.
Time frame: 5 years
Cumulative incidence of relapse
The proportion of patients who experience a relapse of acute leukemia within two years of achieving complete remission, accounting for competing risk of death without relapse.
Time frame: 2 years
Molecular remission rate after consolidation
The proportion of patients who achieve a negative molecular test by PCR for PML-RARA after completing the consolidation phase of treatment.
Time frame: 150 days
PML/RARA transcript level during treatment
The quantitative measurement of the PML/RARA fusion gene transcript, assessed by PCR, at various stages of therapy.
Time frame: Each 3 months
Days of hospitalization during treatment
The total length of time a patient spends in the hospital for the administration of treatment, management of complications, or observation during the course of therapy.
Time frame: 180 days
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