Trials with gemtuzumab ozogamicin (Mylotarg) combined with chemotherapy regimens in acute myeloid leukemia.

Gemtuzumab ozogamicin (Mylotarg) is an immunoconjugate composed of a recombinant humanized murine anti-CD33 antibody linked to calicheamicin, a potent cytotoxic agent. The aim of this review is to summarize ongoing trials with gemtuzumab ozogamicin in combination with chemotherapy in acute myeloid leukemia (AML) patients. The studies include determination of safety and efficacy of gemtuzumab ozogamicin in combination with chemotherapy in previously untreated as well as relapsed and refractory AML patients. These studies also determine gemtuzumab ozogamicin's activity in patients with other CD33+ neoplastic diseases such as myelodysplastic syndrome, acute promyelocytic leukemia, chronic myeloid leukemia, and certain subsets of acute lymphocytic leukemia. Moreover, trials are exploring the use of gemtuzumab ozogamicin with novel targeted agents such as Bcl-2 antisense molecules. Gemtuzumab ozogamicin is associated with an acceptable toxicity profile as a single agent; however, the incidence of veno-occlusive disease remains a concern with the use of gemtuzumab ozogamicin in combination with chemotherapy.