An Open Label, Dose-Escalation Safety and Pharmacokinetic Study of AVE9633 Administered as a Single Agent by Intravenous Infusion on Day 1, Day 4 and Day 7 of a 4-Week Cycle in Patients With Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia (AML)

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.