LFB-R603 Dose Finding in Patients With Advanced Stage B-Chronic Lymphocytic Leukemia

April 27, 2012 updated by: Laboratoire français de Fractionnement et de Biotechnologies

Open, Non-controlled, Multicentre, First-in-man Study Using Escalating Doses of LFB-R603 in Patients With Advanced Stage B-Chronic Lymphocytic Leukemia

This study is designed to evaluate the safety, pharmacokinetics and preliminary efficacy of the anti-CD20 monoclonal antibody LFB-R603 in patients with relapsed or refractory B-cell chronic lymphocytic leukemia who have received at least one prior fludarabine-containing regimen.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Le Mans, France, 72000
        • Clinique Victor Hugo
      • Lille, France, 59037
        • Hôpital Hurriez
      • Marseille, France, 13273
        • Institut Paoli Calmettes
      • Montpellier, France, 34295
        • Hopital Saint Eloi
      • Pierre Bénite, France, 69495
        • CH Lyon Sud
      • Rennes, France, 35033
        • Hôpital Pontchaillou
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Vandoeuvre Les Nancy, France, 54511
        • Hôpital de Brabois
      • Villejuif, France, 94800
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed informed consent
  • Relapsed or refractory B-CLL after at least one prior course of therapy with fludarabine
  • Circulating lymphocytes expressing CD20
  • Peripheral blood lymphocyte count > 5,000/µL
  • ECOG performance status ≤ 2
  • Life expectancy ≥ 3 months
  • Negative blood pregnancy test before inclusion for women of childbearing potential
  • Medically acceptable method of birth control throughout the study for women of childbearing potential
  • Being considered as reliable and capable of adhering to the protocol and compliant with study procedures
  • Covered by healthcare insurance

Exclusion Criteria:

  • Transformation of CLL into a high grade lymphoma
  • Allogeneic stem cell transplantation < 6 months before enrolment
  • Prior treatment with anti-CD20 monoclonal antibodies < 6 months before enrolment
  • Prior treatment with alemtuzumab < 2 months before enrolment
  • Treatment with any IMP or participation in a clinical study within 30 days prior to enrolment
  • Known severe anaphylactic or other hypersensitivity reactions secondary to a prior exposure to murine antibodies or to any component of LFB-R603
  • Patient with prior treatment or concomitant medication that may interfere with the interpretation of the study data
  • Patient with a concomitant malignancy other than basal cell carcinoma of the skin, or in situ carcinoma of the cervix or the breast
  • Patient with serious non-malignant disease, active infection requiring systemic antibiotic, antifungal or antiviral drug or physical examination or laboratory abnormalities, that would compromise protocol objectives
  • Positive serology to HIV, HCV or presence of HBs Ag
  • Creatinine clearance, calculated according to Cockroft -Gault formula < 60 mL/min
  • ALT and /or AST level > 1.5 times the upper limit of normal
  • Pregnancy or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety evaluated by adverse event(s) is the primary end-point of the study. Adverse events will be reported throughout the study period using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Time Frame: on going
on going

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoire français de Fractionnement et de Biotechnologies

Investigators

  • Principal Investigator: Vincent RIBRAG, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

March 31, 2010

First Submitted That Met QC Criteria

April 1, 2010

First Posted (Estimate)

April 2, 2010

Study Record Updates

Last Update Posted (Estimate)

April 30, 2012

Last Update Submitted That Met QC Criteria

April 27, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD20-0703

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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