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
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
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Le Mans, France, 72000
- Clinique Victor Hugo
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Lille, France, 59037
- Hôpital Hurriez
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Marseille, France, 13273
- Institut Paoli Calmettes
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Montpellier, France, 34295
- Hopital Saint Eloi
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Pierre Bénite, France, 69495
- CH Lyon sud
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Rennes, France, 35033
- Hopital Pontchaillou
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Rouen, France, 76038
- Centre Henri Becquerel
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Vandoeuvre Les Nancy, France, 54511
- Hôpital de Brabois
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Villejuif, France, 94800
- Institut Gustave Roussy
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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 |
|---|---|
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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
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on going
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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.
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.