Status:
TERMINATED
SAR3419 in Acute Lymphoblastic Leukemia
Lead Sponsor:
Sanofi
Conditions:
Acute Lymphocytic Leukaemia
Eligibility:
All Genders
16+ years
Phase:
PHASE2
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 = ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01440179
Start Date
October 1 2011
End Date
May 1 2014
Last Update
September 21 2022
Active Locations (11)
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1
Investigational Site Number 840006
Denver, Colorado, United States, 80218
2
Investigational Site Number 840003
Nashville, Tennessee, United States, 37203
3
Investigational Site Number 840001
Houston, Texas, United States, 77030
4
Investigational Site Number 840002
San Antonio, Texas, United States, 78229