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

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-002601-40-FR

Enrollment

Registered

2008-08-19

Start date

2008-09-25

Completion date

Unknown

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B-Chronic Lymphocytic Leukemia MedDRA version: 11 Level: LLT Classification code 10008960 Term:

Interventions

Product Name: Recombinant monoclonal anti-CD20 antibody Product Code: LFB-R603 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Recombinant monoclonal anti-CD20 antibody Current Sponsor

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: 1. Transformation of CLL into a high grade lymphoma 2. Allogeneic stem-cell transplantation 1,5 times the upper limit of normal 10. Pregnancy or breastfeeding

Design outcomes

Primary

Measure	Time frame
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 : For phase I, to select the recommended dose regimen for phase II For phase I and II : - to assess the pharmacokinetic parameters of LFB-R603 - to assess the immunogenicity of LFB-R603 - to assess the efficacy of LFB-R603 based on laboratory, clinical and radiological exams - to present a descriptive statistics of vital signs and laboratory values ;Primary end point(s): 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	—

Measure

Time frame

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 : For phase I, to select the recommended dose regimen for phase II For phase I and II : - to assess the pharmacokinetic parameters of LFB-R603 - to assess the immunogenicity of LFB-R603 - to assess the efficacy of LFB-R603 based on laboratory, clinical and radiological exams - to present a descriptive statistics of vital signs and laboratory values ;Primary end point(s): 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

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Countries

France

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026