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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


Phase 2
16 Years
N/A
Open (Enrolling)
Both
Acute Lymphocytic Leukaemia

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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 840001San Antonio, Texas  78229
Investigational Site Number 840002Houston, Texas  77030