NCT01098188

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2008

Typical duration for phase_1

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 2, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

April 30, 2012

Status Verified

April 1, 2012

Enrollment Period

2.7 years

First QC Date

March 31, 2010

Last Update Submit

April 27, 2012

Conditions

Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

LFB-R603DRUG

intravenous administration, dose-escalation study

Also known as: ublituximab

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Clinique Victor Hugo

Le Mans, 72000, France

Location

Hôpital Hurriez

Lille, 59037, France

Location

Institut Paoli Calmettes

Marseille, 13273, France

Location

Hôpital Saint Eloi

Montpellier, 34295, France

Location

CH Lyon Sud

Pierre-Bénite, 69495, France

Location

Hôpital Pontchaillou

Rennes, 35033, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Hôpital de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Institut Gustave Roussy

Villejuif, 94800, France

Location

Related Publications (1)

  • 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.

    PMID: 18302712BACKGROUND

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

LFB-R603ublituximab

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Vincent RIBRAG, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 31, 2010

First Posted

April 2, 2010

Study Start

November 1, 2008

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

April 30, 2012

Record last verified: 2012-04

Locations

FR(9)