SAR3419 in Acute Lymphoblastic Leukemia

Phase 2

Terminated

• Conditions: Acute Lymphocytic Leukaemia
• Interventions: Drug: SAR3419

• Registration Number: NCT01440179
• Lead Sponsor: Sanofi

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.

Study Timeline

• Study First Submitted: 2011-09-21
• Study First Submitted QC: 2011-09-22
• Study First Posted: 2011-09-26
• Study Start: 2011-10
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2022-09
• Disposition First Submitted: 2022-09-08
• Disposition First Submitted QC: 2022-09-15
• Last Update Submitted: 2022-09-15
• Disposition First Posted: 2022-09-21
• Last Update Posted: 2022-09-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SAR3419	SAR3419	Administered for one to two induction cycles, followed by maintenance cycles up to 6 cycles.

Primary Outcome Measures

Name	Time	Method
Number of participants achieving an Objective Response Rate	4 to 8 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (11)

Investigational Site Number 840001; 🇺🇸 Houston, 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 250004; 🇫🇷 Rennes, France

Investigational Site Number 250005; 🇫🇷 Strasbourg, France

Investigational Site Number 250008; 🇫🇷 Pierre Benite, France

Investigational Site Number 840006; 🇺🇸 Denver, Colorado, United States

Investigational Site Number 840002; 🇺🇸 San Antonio, Texas, United States

Investigational Site Number 840003; 🇺🇸 Nashville, Tennessee, United States