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

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratoire français de Fractionnement et de Biotechnologies

Criteria

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