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

Primary Purpose

Chronic Lymphocytic Leukemia

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
LFB-R603
Sponsored by
Laboratoire français de Fractionnement et de Biotechnologies
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Clinique Victor Hugo
  • Hôpital Hurriez
  • Institut Paoli Calmettes
  • Hôpital Saint Eloi
  • CH Lyon Sud
  • Hôpital Pontchaillou
  • Centre Henri Becquerel
  • Hôpital de Brabois
  • Institut Gustave Roussy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 31, 2010
Last Updated
April 27, 2012
Sponsor
Laboratoire français de Fractionnement et de Biotechnologies
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1. Study Identification

Unique Protocol Identification Number
NCT01098188
Brief Title
LFB-R603 Dose Finding in Patients With Advanced Stage B-Chronic Lymphocytic Leukemia
Official Title
Open, Non-controlled, Multicentre, First-in-man Study Using Escalating Doses of LFB-R603 in Patients With Advanced Stage B-Chronic Lymphocytic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Laboratoire français de Fractionnement et de Biotechnologies

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
LFB-R603
Other Intervention Name(s)
ublituximab
Intervention Description
intravenous administration, dose-escalation study
Primary Outcome Measure Information:
Title
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
Time Frame
on going

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent RIBRAG, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Victor Hugo
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Hôpital Hurriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
Hôpital Saint Eloi
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CH Lyon Sud
City
Pierre Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
Hôpital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Hôpital de Brabois
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
18302712
Citation
de Romeuf C, Dutertre CA, Le Garff-Tavernier M, Fournier N, Gaucher C, Glacet A, Jorieux S, Bihoreau N, Behrens CK, Beliard R, Vieillard V, Cazin B, Bourel D, Prost JF, Teillaud JL, Merle-Beral H. Chronic lymphocytic leukaemia cells are efficiently killed by an anti-CD20 monoclonal antibody selected for improved engagement of FcgammaRIIIA/CD16. Br J Haematol. 2008 Mar;140(6):635-43. doi: 10.1111/j.1365-2141.2007.06974.x.
Results Reference
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LFB-R603 Dose Finding in Patients With Advanced Stage B-Chronic Lymphocytic Leukemia

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