Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-25 @ 2:52 AM
NCT ID:
NCT02999633
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 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.
Detailed 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:
NCT02999633
Study Brief:
Protocol Section:
NCT02999633