Acute Lymphocytic Leukaemia
Conditions
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.
Interventions
DRUGSAR3419
Pharmaceutical form: concentrate solution for infusion Route of administration: intravenous
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants achieving an Objective Response Rate | 4 to 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Number of participants with Adverse Events | Up to 1 year |
| Assessment of PK parameter - volume in steady state (Vss) | Up to 8 months |
| Assessment of minimal residual disease (MRD) | 4 to 8 weeks |
| Assessment of PK parameter - clearance | Up to 8 months |
Countries
France, United States
Outcome results
None listed