SAR3419 in Acute Lymphoblastic Leukemia

Overview

Primary Objective: Participants achieving an Objective Response Rate Secondary Objectives: – Response duration – Progression Free Survival – Minimal residual disease – Safety – Pharmacokinetics

Full Title of Study: “Phase II Two Stage Finding Run-in Study of SAR3419, An Anti-CD19 Antibody-Maytansine Conjugate, Administered as a Single Agent by Intravenous Infusion in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2014

Detailed Description

The duration of the study for an individual patient will include: – The screening period = up to 4 weeks prior to the first administration of SAR3419. – The treatment period: – Induction period = 4 to 8 weeks – Maintenance = up to a total maintenance treatment of 6 months – A safety follow-up period of 42 days after the last dose. – Any patient who discontinues the study treatment without disease progression will be followed every 2 months until disease progression, initiation of a new anti-cancer therapy, death or end-of-study date, whatever comes first.

Interventions

  • Drug: SAR3419
    • Pharmaceutical form: concentrate solution for infusion Route of administration: intravenous

Arms, Groups and Cohorts

  • Experimental: SAR3419
    • Administered for one to two induction cycles, followed by maintenance cycles up to 6 cycles.

Clinical Trial Outcome Measures

Primary Measures

  • Number of participants achieving an Objective Response Rate
    • Time Frame: 4 to 8 weeks

Secondary Measures

  • Number of participants with Adverse Events
    • Time Frame: Up to 1 year
  • Assessment of PK parameter – maximum concentration (Cmax)
    • Time Frame: Up to 8 months
  • Assessment of PK parameter – area under curve (AUC)
    • Time Frame: Up to 8 months
  • Assessment of PK parameter – half-life (T1/2)
    • Time Frame: Up to 8 months
  • Assessment of PK parameter – clearance
    • Time Frame: Up to 8 months
  • Assessment of PK parameter – volume in steady state (Vss)
    • Time Frame: Up to 8 months
  • Assessment of minimal residual disease (MRD)
    • Time Frame: 4 to 8 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Previously treated Acute Lymphoblastic Leukemia of B cell origin (including Burkitt's lymphoma) in relapse or primary refractory. Patients in first relapse will be eligible regardless of the first remission duration. – No more than 3 prior salvage therapies. – Philadelphia positive patients failing treatment with imatinib mesylate are accepted. – CD19 positive patients. Exclusion criteria:

None The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sanofi
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Sciences & Operations, Study Director, Sanofi

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