Last updated on October 2017

Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia

Brief description of study

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.

Detailed Study Description

The study duration per patient will include 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.

Clinical Study Identifier: NCT02999633

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Investigational Site Number 2460001
Helsinki, Finland
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