Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia
Status:
Terminated
Trial end date:
2017-11-14
Target enrollment:
Participant gender:
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 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.