Posadas

Researchers are gathering real world evidence on adult patients in Argentina diagnosed with acute promyelocytic leukemia (APL) who receive first line treatment based on arsenic trioxide (ATO) and all trans retinoic acid (ATRA). The study aims to evaluate the overall survival and event free survival of these patients when treated with ATO/ATRA alone or combined with Idarubicin (IDA) depending on their risk category. Secondary goals include measuring complete molecular response, treatment toxicity, early mortality, and the role of the FLT3 gene in prognosis. Patients are classified by risk based on their white blood cell counts, with high risk defined as counts over 10,000 and low risk as below 10,000. All patients undergo induction treatment with daily ATO plus ATRA until remission or up to 60 days. High risk patients receive 2-3 doses of IDA at induction start and may receive central nervous system prophylaxis if needed. Consolidation involves ATO given 5 days a week in cycles of 4 weeks on and 4 weeks off for 4 courses, and ATRA given 2 weeks on and 2 weeks off for 7 courses. During the study, molecular response is monitored by RQ-PCR at the end of consolidation. Low risk patients who achieve complete molecular remission do not require further molecular tests, but high risk patients have RQ-PCR every 3 months in the first year and every 6 months in the second year. Researchers will track survival outcomes, toxicity, and treatment response over 36 months, providing prospective follow-up and evaluation of treatment results in a real world clinical setting.