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

Phase 1

Completed

• Conditions: Chronic Lymphocytic Leukemia

• Registration Number: NCT01098188
• Lead Sponsor: Laboratoire français de Fractionnement et de Biotechnologies

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2010-03-31
• Study First Submitted QC: 2010-04-01
• Study First Posted: 2010-04-02
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-27
• Last Update Posted: 2012-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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	on going

Trial Locations

Locations (9)

Hôpital Saint Eloi; 🇫🇷 Montpellier, France

Clinique Victor Hugo; 🇫🇷 Le Mans, France

Hôpital Hurriez; 🇫🇷 Lille, France

Hôpital Pontchaillou; 🇫🇷 Rennes, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Institut Paoli Calmettes; 🇫🇷 Marseille, France

Hôpital de Brabois; 🇫🇷 Vandoeuvre Les Nancy, France

CH Lyon Sud; 🇫🇷 Pierre Bénite, France