Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia

Phase 2, Safety and Efficacy Study of Isatuximab, an Anti-CD38 Monoclonal Antibody, Administered by Intravenous (IV) Infusion in Patients With Relapsed or Refractory T-acute Lymphoblastic Leukemia (T-ALL) or T-lymphoblastic Lymphoma (T-LBL)

Primary Objective:

To evaluate the efficacy of isatuximab.

Secondary Objectives:

• To evaluate the safety profile of isatuximab.
• To evaluate the duration of response (DOR).
• To evaluate progression free survival (PFS) and overall survival (OS).
• To evaluate the pharmacokinetics (PK) of isatuximab in participants with T-ALL or T-LBL.
• To evaluate immunogenicity of isatuximab in participants with T-ALL or T-LBL.
• To assess minimal residual disease (MRD) and correlate it with clinical outcome.

The study duration per participant included 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 :

• Participants must had a known diagnosis of acute lymphoblastic leukemia (ALL) of T cell origin, including T-LBL and T-ALL with extramedullary involvement at relapse confirmed by biopsy.
• Participants must be previously treated for T-ALL or T-LBL and have relapsed or are refractory to most recent treatment. Participants in first relapse were be eligible regardless of the first remission duration.
• Participants must had 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 was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.