SAR3419 in Acute Lymphoblastic Leukemia

The duration of the study for an individual patient will include:

- The screening period = up to 4 weeks prior to the first administration of SAR3419.

- The treatment period:

- Induction period = 4 to 8 weeks

- Maintenance = up to a total maintenance treatment of 6 months

- A safety follow-up period of 42 days after the last dose.

- Any patient who discontinues the study treatment without disease progression will be
followed every 2 months until disease progression, initiation of a new anti-cancer
therapy, death or end-of-study date, whatever comes first.

Inclusion criteria:

- Previously treated Acute Lymphoblastic Leukemia of B cell origin (including Burkitt's
lymphoma) in relapse or primary refractory. Patients in first relapse will be
eligible regardless of the first remission duration.

- No more than 3 prior salvage therapies.

- Philadelphia positive patients failing treatment with imatinib mesylate are accepted.

- CD19 positive patients.

Exclusion criteria:

None

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.