Clinical Trial: Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Lymp

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 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 Summary: 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.
Sponsor: Sanofi

Current Primary Outcome: Objective response rate [ Time Frame: 6 months after last patient 1st administration (Day 1), 12 months after last patient 1st administration (Day 1) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Duration of response - time [ Time Frame: 6 months after last patient 1st administration (Day 1), 12 months after last patient 1st administration (Day 1) ]
  • Progression free survival - time [ Time Frame: 6 months after last patient 1st administration (Day 1), 12 months after last patient 1st administration (Day 1) ]
  • Overall survival - time [ Time Frame: 6 months after last patient 1st administration (Day 1), 12 months after last patient 1st administration (Day 1) ]


Original Secondary Outcome: Same as current

Information By: Sanofi

Dates:
Date Received: December 19, 2016
Date Started: March 8, 2017
Date Completion: May 25, 2020
Last Updated: May 11, 2017
Last Verified: May 2017