Real World Study of Arsenic Trioxide and All Trans Retinoic Acid Treatment in Adults with Acute Promyelocytic Leukemia in Argentina

What this Trial Is About

This research aims to collect real world evidence on adult patients in Argentina diagnosed with acute promyelocytic leukemia APL who receive first-line treatment using arsenic trioxide plus all trans retinoic acid ATOATRA based regimens. The study evaluates outcomes including event-free survival and overall survival, with additional focus on complete molecular response rates, treatment toxicity, early mortality, and the prognostic role of the FLT3 mutation. Patients will follow local guidelines where risk is determined by white blood cell counts high-risk WBC >10,000 or low-risk WBC <10,000. All patients receive induction with daily ATO plus ATRA until remission or for up to 60 days. High-risk patients also receive 2-3 doses of idarubicin at induction start. Consolidation includes cycles of ATO given 5 days a week in alternating 4-week periods and ATRA in alternating 2-week periods. Central nervous system prophylaxis is provided for high-risk patients or those with CNS bleeding. Participants will be monitored through molecular testing at consolidation end and periodically for high-risk patients during the first two years. Researchers will collect data on survival outcomes, molecular remission, toxicity, and early mortality. The study involves following patients over 36 months to assess long-term treatment effects and prognostic markers.

RWE of 1st Line Treatment With ATO/ATRA for Adult APL