SAR3419 in Acute Lymphoblastic Leukemia

Phase II Two Stage Finding Run-in Study of SAR3419, An Anti-CD19 Antibody-Maytansine Conjugate, Administered as a Single Agent by Intravenous Infusion in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

Primary Objective:

Participants achieving an Objective Response Rate

Secondary Objectives:

• Response duration
• Progression Free Survival
• Minimal residual disease
• Safety
• Pharmacokinetics

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.