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
16 Years
N/A
Both
Acute Lymphocytic Leukaemia
Trial Information
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
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.
Inclusion Criteria
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of participants achieving an Objective Response Rate
Outcome Time Frame:
4 to 8 weeks
Safety Issue:
No
Principal Investigator
Clinical Sciences & Operations
Investigator Role:
Study Director
Investigator Affiliation:
Sanofi
Authority:
United States: Food and Drug Administration
Study ID:
EFC11603
NCT ID:
NCT01440179
Start Date:
October 2011
Completion Date:
December 2014
Related Keywords:
- Acute Lymphocytic Leukaemia
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
Name | Location |
|---|---|
| Investigational Site Number 840001 | San Antonio, Texas 78229 |
| Investigational Site Number 840002 | Houston, Texas 77030 |
