The primary objective is to determine the maximum tolerated dose of AVE9633 and to characterize the dose limiting toxicity(ies). Secondary objectives are to determine the anti-leukemia activity, the global safety and the PK profile.
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.
