Spots Global Cancer Trial Database for SAR3419 in Acute Lymphoblastic Leukemia
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Trial Identification
Brief Title: SAR3419 in Acute Lymphoblastic Leukemia
Official Title: 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 ID: NCT01440179
Conditions
Interventions
Study Description
Brief Summary: Primary Objective: Participants achieving an Objective Response Rate Secondary Objectives: * Response duration * Progression Free Survival * Minimal residual disease * Safety * Pharmacokinetics
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.
Keywords
Eligibility
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Investigational Site Number 840006, Denver, Colorado, United States
Investigational Site Number 840003, Nashville, Tennessee, United States
Investigational Site Number 840001, Houston, Texas, United States
Investigational Site Number 840002, San Antonio, Texas, United States
Investigational Site Number 840004, Milwaukee, Wisconsin, United States
Investigational Site Number 250006, Amiens, , France
Investigational Site Number 250001, Paris Cedex 10, , France
Investigational Site Number 250002, Pessac, , France
Investigational Site Number 250008, Pierre Benite, , France
Investigational Site Number 250004, Rennes, , France
Investigational Site Number 250005, Strasbourg, , France
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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