SAR3419 in Acute Lymphoblastic Leukemia

Study Overview
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Brief Summary
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Primary Objective: Participants achieving an Objective Response Rate Secondary Objectives: Response duration Progression Free Survival Minimal residual disease Safety Pharmacokinetics

Detailed Description
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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.

Official Title
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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

Conditions
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Acute Lymphocytic Leukaemia

Intervention / Treatment
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* Drug: SAR3419


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAR3419<br>Administered for one to two induction cycles, followed by maintenance cycles up to 6 cycles. | Drug: SAR3419<br>* Pharmaceutical form: concentrate solution for infusion Route of administration: intravenous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants achieving an Objective Response Rate |  | 4 to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Adverse Events |  | Up to 1 year | 
| Assessment of PK parameter - maximum concentration (Cmax) |  | Up to 8 months | 
| 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 | 
| Assessment of minimal residual disease (MRD) |  | 4 to 8 weeks |