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

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