Chronic Lymphocytic Leukemia
Conditions
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.
Interventions
DRUGLFB-R603
intravenous administration, dose-escalation study
Sponsors
Laboratoire français de Fractionnement et de Biotechnologies
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Countries
France
Outcome results
None listed