Real-World Efficacy and Safety of Gemtuzumab Ozogamycin (GO) and 3 + 7 regimen in fit newly diagnosed Acute Myeloid Leukemia (AML) patients. A Retrospective multicenter study of "Rete Ematologica Pugliese" (REP).

Gemtuzumab Ozogamicin, a monoclonal antibody targeting CD33, linked to calicheamicin, is approved in combination with "3 + 7″ for the treatment of patients with de novo CD33 positive AML. The aim of study was to evaluate the outcome of patients receiving 3 + 7 plus GO as front-line therapy outside clinical trials. Between March 2020 and February 2023, 34 consecutive fit CD33+ AML patients, median age 54.5 years (range, 25-75) were treated. This study confirms the efficacy and toxicity data reported in clinical trials, highlighting the feasibility of GO based chemotherapy also in patients older than 60 years and as a bridge to allo-HSCT.