T-lymphoblastic Lymphoma/Leukaemia Clinical Trial
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 (T-ALL) or T-lymphoblastic Lymphoma (T-LBL)
To evaluate the efficacy of isatuximab.
- 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.
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. ;
|Start date||March 8, 2017|
|Completion date||November 14, 2017|