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Clinical Trial 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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms

  • Leukemia
  • Leukemia, Lymphoid
  • Lymphoma
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
  • T-cell Type Acute Leukemia-Precursor
  • T-lymphoblastic Lymphoma/Leukaemia

NCT number NCT02999633
Study type Interventional
Source Sanofi
Contact
Status Terminated
Phase Phase 2
Start date March 8, 2017
Completion date November 14, 2017