Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia

Stopped early · Phase 2

Conditions studied: T-cell Type Acute Leukemia-Precursor, T-lymphoblastic Lymphoma/Leukaemia

In brief

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.

Key facts

Study ID

NCT02999633

Run by

Sanofi

People needed

14

Starts

2017-03-08

Expected to finish

2017-11-14

Last updated by the study team

2022-03-21

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must had a known diagnosis of acute lymphoblastic leukemia (ALL) of T cell origin, including T-LBL and T-ALL with extramedullary involvement at relapse confirmed by biopsy.
• Participants must be previously treated for T-ALL or T-LBL and have relapsed or are refractory to most recent treatment. Participants in first relapse were be eligible regardless of the first remission duration.
• Participants must had been previously exposed to nelarabine in countries where this drug is available (unless due to a contraindication to its use or administrative issue).
• No more than 3 prior salvage therapies.

You may not qualify if…

• Prior treatment with immunotherapy/investigational agents within 3 weeks, chemotherapy within 2 weeks of study treatment. Must have recovered from acute toxicity before first study treatment administration.
• Prior stem cell transplant within 4 months and/or evidence of active systemic Graft versus Host Disease and/or immunosuppressive therapy for Graft versus Host Disease within 1 week before the first study treatment administration.
• Clinical evidence of active central nervous system (CNS) leukemia.
• T-ALL with testicular involvement alone.
• The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where it is running

• Investigational Site Number 8400002 — Atlanta, Georgia, United States
• Investigational Site Number 8400003 — Hackensack, New Jersey, United States
• Investigational Site Number 8400001 — Houston, Texas, United States
• Investigational Site Number 2460001 — Helsinki, Finland
• Investigational Site Number 2500005 — Nantes, France
• Investigational Site Number 2500001 — Paris, France
• Investigational Site Number 2500004 — Pessac, France
• Investigational Site Number 2500002 — Pierre-Bénite, France
• Investigational Site Number 3480001 — Budapest, Hungary
• Investigational Site Number 3480003 — Budapest, Hungary
• Investigational Site Number 3480002 — Debrecen, Hungary
• Investigational Site Number 3800001 — Bergamo, Italy
• Investigational Site Number 3800004 — Brescia, Italy
• Investigational Site Number 4400001 — Vilnius, Lithuania
• Investigational Site Number 6430003 — Moscow, Russia
• Investigational Site Number 6430004 — Moscow, Russia
• Investigational Site Number 6430001 — Moscow, Russia

Full record on ClinicalTrials.gov

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