Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia
Condition: T-cell Type Acute Leukemia-Precursor; T-lymphoblastic Lymphoma/Leukaemia
MeSH terms: Lymphoma; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Intervention: Isatuximab SAR650984; dexamethasone; dexamethasone; acetaminophen; ranitidine; diphenhydramine
Intervention description: Pharmaceutical form:solution Route of administration: intravenous; Pharmaceutical form:pills Route of administration: oral; Pharmaceutical form:solution Route of administration: intravenous; Pharmaceutical form:pills Route of administration: oral; Pharmaceutical form:solution Route of administration: intravenous; Pharmaceutical form:solution Route of administration: intravenous
Intervention MeSH terms: Acetaminophen; Diphenhydramine; Promethazine; Dexamethasone; Dexamethasone acetate; Ranitidine; Ranitidine bismuth citrate; BB 1101
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion criteria :

          -  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.

        Exclusion criteria:

          -  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.