NCT01440179

Brief Summary

Primary Objective: Participants achieving an Objective Response Rate Secondary Objectives:

  • Response duration
  • Progression Free Survival
  • Minimal residual disease
  • Safety
  • Pharmacokinetics

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2011

Geographic Reach
2 countries

11 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 26, 2011

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

September 21, 2022

Status Verified

September 1, 2022

Enrollment Period

2.6 years

First QC Date

September 21, 2011

Last Update Submit

September 15, 2022

Conditions

Acute Lymphocytic Leukaemia

Outcome Measures

Primary Outcomes (1)

  • Number of participants achieving an Objective Response Rate

    4 to 8 weeks

Secondary Outcomes (7)

  • Number of participants with Adverse Events

    Up to 1 year

  • Assessment of PK parameter - maximum concentration (Cmax)

    Up to 8 months

  • Assessment of PK parameter - area under curve (AUC)

    Up to 8 months

  • Assessment of PK parameter - half-life (T1/2)

    Up to 8 months

  • Assessment of PK parameter - clearance

    Up to 8 months

  • +2 more secondary outcomes

Study Arms (1)

SAR3419

EXPERIMENTAL

Administered for one to two induction cycles, followed by maintenance cycles up to 6 cycles.

Drug: SAR3419

Interventions

SAR3419DRUG

Pharmaceutical form: concentrate solution for infusion Route of administration: intravenous

SAR3419

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • None
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Investigational Site Number 840006

Denver, Colorado, 80218, United States

Location

Investigational Site Number 840003

Nashville, Tennessee, 37203, United States

Location

Investigational Site Number 840001

Houston, Texas, 77030, United States

Location

Investigational Site Number 840002

San Antonio, Texas, 78229, United States

Location

Investigational Site Number 840004

Milwaukee, Wisconsin, 53226, United States

Location

Investigational Site Number 250006

Amiens, 80054, France

Location

Investigational Site Number 250001

Paris, 75475, France

Location

Investigational Site Number 250002

Pessac, 33600, France

Location

Investigational Site Number 250008

Pierre-Bénite, 69310, France

Location

Investigational Site Number 250004

Rennes, 35033, France

Location

Investigational Site Number 250005

Strasbourg, 67200, France

Location

Related Publications (1)

  • 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.

    PMID: 23426279DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

coltuximab ravtansine

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2011

First Posted

September 26, 2011

Study Start

October 1, 2011

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

September 21, 2022

Record last verified: 2022-09

Locations

US(5)FR(6)