SAR3419 in Acute Lymphoblastic Leukemia
Phase 1
- Conditions
- Acute lymphoblastic leukemiaMedDRA version: 16.1Level: PTClassification code 10000846Term: Acute lymphocytic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-002961-36-FR
- Lead Sponsor
- Sanofi-aventis recherche et développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
1/ 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.
2/ No more than 3 prior salvage therapies.
3/ Philapdelphia positive patients failing treatment with imatinib mesylate are accepted.
4/ CD19 positive patients.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
Exclusion Criteria
E 01. Age <16 years
E 02. ECOG performance status >2
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method