Clinical trial NCT01440179: SAR3419 in Acute Lymphoblastic Leukemia
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Lymphocytic Leukaemia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2011-09-26
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 = 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.

Eligibility 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.

Primary outcomes:
measure: Number of participants achieving an Objective Response Rate
timeFrame: 4 to 8 weeks
Secondary outcomes:
measure: Number of participants with Adverse Events
timeFrame: Up to 1 year
measure: Assessment of PK parameter - maximum concentration (Cmax)
timeFrame: Up to 8 months
measure: Assessment of PK parameter - area under curve (AUC)
timeFrame: Up to 8 months
measure: Assessment of PK parameter - half-life (T1/2)
timeFrame: Up to 8 months
measure: Assessment of PK parameter - clearance
timeFrame: Up to 8 months
measure: Assessment of PK parameter - volume in steady state (Vss)
timeFrame: Up to 8 months
measure: Assessment of minimal residual disease (MRD)
timeFrame: 4 to 8 weeks
Other outcomes:
Locations:
city: Denver
country: United States
facility: Investigational Site Number 840006
state: Colorado
city: Nashville
country: United States
facility: Investigational Site Number 840003
state: Tennessee
city: Houston
country: United States
facility: Investigational Site Number 840001
state: Texas
city: San Antonio
country: United States
facility: Investigational Site Number 840002
state: Texas
city: Milwaukee
country: United States
facility: Investigational Site Number 840004
state: Wisconsin
city: Amiens
country: France
facility: Investigational Site Number 250006
city: Paris Cedex 10
country: France
facility: Investigational Site Number 250001
city: Pessac
country: France
facility: Investigational Site Number 250002
city: Pierre Benite
country: France
facility: Investigational Site Number 250008
city: Rennes
country: France
facility: Investigational Site Number 250004
city: Strasbourg
country: France
facility: Investigational Site Number 250005
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Carol H, Szymanska B, Evans K, Boehm I, Houghton PJ, Smith MA, Lock RB. The anti-CD19 antibody-drug conjugate SAR3419 prevents hematolymphoid relapse postinduction therapy in preclinical models of pediatric acute lymphoblastic leukemia. Clin Cancer Res. 2013 Apr 1;19(7):1795-805. doi: 10.1158/1078-0432.CCR-12-3613. Epub 2013 Feb 20.