Dose Escalation Safety and Pharmacokinetic Study of AVE9633 as Single Agent in Relapsed/Refractory CD33-Positive Acute Myeloid Leukemia

Inclusion Criteria: * Patients with CD33-positive acute myeloid leukemia, refractory or relapsed after standard treatment with no curative option available * ECOG performance status 0 to 2 Exclusion Criteria: * Therapy with gemtuzumab ozogamicin (Mylotarg) within 6 months prior to inclusion * Allogenic transplantation within 6 months prior to inclusion * Prior therapy (chemotherapy, targeted agents, radiotherapy) within 3 weeks except for hydroxyurea and for leukophoresis * Previous treatment with AVE9633 * Poor kidney, liver and bone marrow functions * Any serious active disease or co-morbid condition, which in the opinion of the principle investigator, will interfere with the safety or with compliance with the study * Pregnant or breast-feeding women * Patient with reproductive potential without effective birth control methods The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.