NCT01440179

SAR3419 in Acute Lymphoblastic Leukemia

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Lymphocytic Leukaemia

Interventions

Type	Name	Description
DRUG	SAR3419	Pharmaceutical form: concentrate solution for infusion Route of administration: intravenous

Timeline

• Start date: 2011-10-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2011-09-26
• Last updated: 2022-09-21

Locations

11 sites across 2 countries: United States, France