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

LFB

Status and phase

Completed

Phase 1

Conditions

Chronic Lymphocytic Leukemia

Treatments

Drug: LFB-R603

Study type

Interventional

Funder types

Industry

Identifiers

NCT01098188

CD20-0703

Details and patient eligibility

About

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.

Enrollment

33 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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