SAR3419 in Acute Lymphoblastic Leukemia

Acute Lymphocytic Leukaemia Clinical Trial

— MYRALL  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01440179
• Other study ID #: EFC11603
• Secondary ID: U1111-1118-06422
• Status: Terminated
• Phase: Phase 2
• Start date: October 2011
• Est. completion date: May 2014

Study information

• Verified date: September 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

Participants achieving an Objective Response Rate

Secondary Objectives:

• Response duration

• Progression Free Survival

• Minimal residual disease

• Safety

• Pharmacokinetics

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lymphocytic Leukaemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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

Locations

Country	Name	City	State
France	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
United States	Investigational Site Number 840006	Denver	Colorado
United States	Investigational Site Number 840001	Houston	Texas
United States	Investigational Site Number 840004	Milwaukee	Wisconsin
United States	Investigational Site Number 840003	Nashville	Tennessee
United States	Investigational Site Number 840002	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants achieving an Objective Response Rate		4 to 8 weeks
Secondary	Number of participants with Adverse Events		Up to 1 year
Secondary	Assessment of PK parameter - maximum concentration (Cmax)		Up to 8 months
Secondary	Assessment of PK parameter - area under curve (AUC)		Up to 8 months
Secondary	Assessment of PK parameter - half-life (T1/2)		Up to 8 months
Secondary	Assessment of PK parameter - clearance		Up to 8 months
Secondary	Assessment of PK parameter - volume in steady state (Vss)		Up to 8 months
Secondary	Assessment of minimal residual disease (MRD)		4 to 8 weeks