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
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of participants achieving an Objective Response Rate
4 to 8 weeks
Clinical Sciences & Operations
United States: Food and Drug Administration
|Investigational Site Number 840001||San Antonio, Texas 78229|
|Investigational Site Number 840002||Houston, Texas 77030|