Gemtuzumab Ozogamicin (Mylotarg) for the Treatment of Acute Myeloid Leukemia – Ongoing Trials

Abstract

The value of the combination of gemtuzumab ozogamicin(GO) and chemotherapy for the treatment of acutemyeloid leukemia (AML) is currently analyzed within clinicaltrials. GO (6 mg/m2) and standard-dose cytarabine(100 mg/m2) is evaluated for the treatment of newly diagnosedAML in elderly patients in the SAL phase II trial.Preliminary results of the MRC AML15 trial support theapplication of GO 3 mg/m2 with standard- and high-dosecytarabine and anthracyclines for the treatment of denovo AML. Within this trial the addition of GO seems especiallyof value for favorable and intermediate cytogeneticrisk groups. The combination of GO (3 mg/m2) andhigh-dose cytarabine (3 g/m2) is safe and more effectivefor the treatment of refractory AML than previous combinationsfrom the AMLSG study group. First results provethe possibility of allogeneic stem cell transplantationafter GO therapy. Initial data of a phase II trial documentthe safety and efficacy profile of GO within a reduced-intensityconditioning protocol applying fludarabine andtotal body irradiation.