Open, non-controlled, multicentre, first-in-man study using escalating doses of LFB-R603 in patients with advanced stage B-Chronic lymphocytic leukemia - CD20-0703

Phase 1

• Conditions: B-Chronic Lymphocytic Leukemia; MedDRA version: 11Level: LLTClassification code 10008960Term: <Manually entered code. Term in E.1.1>

• Registration Number: EUCTR2008-002601-40-FR
• Lead Sponsor: FB BIOTECHNOLOGIES

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-08-19
• Study Completion: 2011-08-23
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

1. Signed and dated informed consent
2. Relapsed or refractory B-CLL after at least one prior course of therapy with Fludarabine (F)
3 .Circulating lymphocytes expressing CD20, CD5, CD19 and CD23 membrane proteins
4 .18 years = age = 80 years, both genders
5. Peripheral blood lymphocyte count > 5.10exp9/l
6. ECOG performance status = 2
7. Life expectancy = 3 months

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Transformation of CLL into a high grade lymphoma
2. Allogeneic stem-cell transplantation < 6 months before enrolment
3. Prior treatment with rituximab and/or ofatumumab < 6 months before enrolment
4. Prior treatment with alemtuzumab < 2 months before enrolment
5. Known severe anaphylactic or other hypersensitivity reactions secondary to a previous exposure to murine antibodies or to any component of LFB-R603
6. Patient with a concomitant malignancy other than basal cell carcinoma of the skin, or in situ carcinoma of the cervix or the breast
7. Patient with serious non-malignant disease, severe / unstable HTA, active infection requiring sytemic antibiotic, antifungal or anti viral drug or physical examination or laboratory abnormalities, that, in the opinion of the Investigator, would compromise protocol objectives
8. Creatinine clearance, calculated according to Cockroft-Gault formula, < 60 mL/min
9. AST and/or ALT level > 1,5 times the upper limit of normal
10. Pregnancy or breastfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective is to assess the safety of LFB-R603 administered to patients suffering from advanced B-CLL, relapsed or refractory after at least one prior course of fludarabin.;Secondary Objective: The secondary objectives are :<br><br>For phase I, to select the recommended dose regimen for phase II<br><br>For phase I and II :<br>- to assess the pharmacokinetic parameters of LFB-R603<br>- to assess the immunogenicity of LFB-R603<br>- to assess the efficacy of LFB-R603 based on laboratory, clinical and radiological exams<br>- to present a descriptive statistics of vital signs and laboratory values<br><br>;Primary end point(s): Safety evaluated by Adverse event(s) is the primary end-point of the study. <br>Adverse events will be reported throughout the study period using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0