SAR3419 in Acute Lymphoblastic Leukemia (MYRALL)

Sanofi

Status and phase

Terminated

Phase 2

Conditions

Acute Lymphocytic Leukaemia

Treatments

Drug: SAR3419

Study type

Interventional

Funder types

Industry

Identifiers

2012-002961-36 (EudraCT Number)

EFC11603

U1111-1118-0642 (Other Identifier)

Details and patient eligibility

About

Primary Objective:

Participants achieving an Objective Response Rate

Secondary Objectives:

Full 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.

Enrollment

100 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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.