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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Lymphocytic Leukemia

Intervention / Treatment
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* Drug: LFB-R603


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: LFB-R603|intravenous administration, dose-escalation study|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | on going |