Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
100 participants
INTERVENTIONAL
2011-10-31
2014-05-31
Brief Summary
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Participants achieving an Objective Response Rate
Secondary Objectives:
* Response duration
* Progression Free Survival
* Minimal residual disease
* Safety
* Pharmacokinetics
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Detailed Description
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* 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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SAR3419
Administered for one to two induction cycles, followed by maintenance cycles up to 6 cycles.
SAR3419
Pharmaceutical form: concentrate solution for infusion Route of administration: intravenous
Interventions
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SAR3419
Pharmaceutical form: concentrate solution for infusion Route of administration: intravenous
Eligibility Criteria
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Inclusion Criteria
* No more than 3 prior salvage therapies.
* Philadelphia positive patients failing treatment with imatinib mesylate are accepted.
* CD19 positive patients.
Exclusion Criteria
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
16 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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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, , France
Investigational Site Number 250002
Pessac, , France
Investigational Site Number 250008
Pierre-Bénite, , France
Investigational Site Number 250004
Rennes, , France
Investigational Site Number 250005
Strasbourg, , France
Countries
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References
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Carol H, Szymanska B, Evans K, Boehm I, Houghton PJ, Smith MA, Lock RB. The anti-CD19 antibody-drug conjugate SAR3419 prevents hematolymphoid relapse postinduction therapy in preclinical models of pediatric acute lymphoblastic leukemia. Clin Cancer Res. 2013 Apr 1;19(7):1795-805. doi: 10.1158/1078-0432.CCR-12-3613. Epub 2013 Feb 20.
Other Identifiers
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U1111-1118-0642
Identifier Type: OTHER
Identifier Source: secondary_id
2012-002961-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EFC11603
Identifier Type: -
Identifier Source: org_study_id
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