Clinical Trial: Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 (

Brief Summary:

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 patients with T-ALL or T-LBL.
To evaluate immunogenicity of isatuximab in patients with T-ALL or T-LBL.
To assess minimal residual disease (MRD) and correlate it with clinical outcome.