Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia

The study duration per patient will include a 3-week screening period, an approximately 1
year of treatment period or until disease progression or discontinuation for any other
reason, and a follow-up period of at least 30 days after the last investigational medicinal
product administration.

Inclusion criteria :

- Patients must have a known diagnosis of ALL of T cell origin, including T-LBL and
T-ALL with extramedullary involvement at relapse confirmed by biopsy.

- Patients must be previously treated for T-ALL or T-LBL and have relapsed or are
refractory to most recent treatment. Patients in first relapse will be eligible
regardless of the first remission duration.

- Patients must have been previously exposed to nelarabine in countries where this drug
is available (unless due to a contraindication to its use or administrative issue).

- No more than 3 prior salvage therapies.

Exclusion criteria:

- Prior treatment with immunotherapy/investigational agents within 3 weeks, chemotherapy
within 2 weeks of study treatment. Must have recovered from acute toxicity before
first study treatment administration.

- Prior stem cell transplant within 4 months and/or evidence of active systemic Graft
versus Host Disease and/or immunosuppressive therapy for Graft versus Host Disease
within 1 week before the first study treatment administration.

- Clinical evidence of active central nervous system (CNS) leukemia.

- T-ALL with testicular involvement alone.

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