NCT00796731

Brief Summary

The primary objective is to determine the maximum tolerated dose (MTD) of SAR3419 according to the dose limiting toxicities (DLTs) observed when administered as a single agent once weekly. Secondary objectives are:

  • to characterize the global safety profile
  • to evaluate the pharmacokinetic (PK) profile of SAR3419 in the proposed dosing schedule
  • to assess preliminary evidence of anti-lymphoma activity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P75+ for phase_1 lymphoma

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

6 active sites

Status
completed

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

Study Start

First participant enrolled

October 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 24, 2008

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

July 17, 2012

Status Verified

July 1, 2012

Enrollment Period

3.7 years

First QC Date

November 21, 2008

Last Update Submit

July 16, 2012

Conditions

LymphomaNon-Hodgkin

Keywords

B-cell lymphomaNHL

Outcome Measures

Primary Outcomes (1)

  • Incidence of DLT(s) at each dose level

    during the initial 3-week period of treatment

Secondary Outcomes (4)

  • Cumulative DLT(s)

    over the entire period of treatment

  • Incidence of Adverse Events and laboratory abnormalities

    study period

  • Tumor response (complete response, partial response) and duration of the response

    study period

  • Pharmacokinetics parameters

    Study period

Interventions

SAR3419DRUG

administered by intravenous infusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of B-cell non Hodgkin's lymphoma
  • Relapsed or refractory after standard treatments and with no curative option with conventional therapy (Patients having undergone stem cell transplantation may be included)
  • CD19 positive disease by flow cytometry or immunohistochemistry

You may not qualify if:

  • Burkitt's lymphoma, Lymphoblastic lymphoma, Chronic lymphocytic leukemia (Small lymphocytic lymphoma may be included)
  • Evidence of cerebral or meningeal involvement by lymphoma
  • Patients without bi-dimensionally measurable disease
  • ECOG performance status \> 2
  • Life expectancy less than 3 months
  • Chemotherapy or radiation therapy or other investigational agents within 4 weeks prior to entering the study
  • Previous radioimmunotherapy within 12 weeks
  • Known anaphylaxis to infused proteins
  • HIV, HBV and HCV positivity
  • Poor kidney, liver and bone marrow functions
  • Any serious active disease or co-morbid condition, which, in the opinion of the principle investigator, will interfere with the safety or the compliance with the study
  • Pregnant or breast-feeding women
  • Patients with reproductive potential without effective birth control methods
  • 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 (6)

Sanofi-Aventis Investigational Site Number 250004

Créteil, 94010, France

Location

Sanofi-Aventis Investigational Site Number 250006

Lille, 59037, France

Location

Sanofi-Aventis Investigational Site Number 250001

Pierre-Bénite, 69495, France

Location

Sanofi-Aventis Investigational Site Number 250005

Rennes, 35033, France

Location

Sanofi-Aventis Investigational Site Number 250003

Rouen, 76038, France

Location

Sanofi-Aventis Investigational Site Number 250002

Villejuif, 94805, France

Location

MeSH Terms

Conditions

LymphomaLymphoma, B-Cell

Interventions

coltuximab ravtansine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-Hodgkin

Study Officials

  • Bertrand COIFFIER, Professor of Hematology

    Centre Hospitalier Lyon Sud, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2008

First Posted

November 24, 2008

Study Start

October 1, 2008

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

July 17, 2012

Record last verified: 2012-07

Locations

FR(6)