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

Chronic Lymphocytic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01098188
• Other study ID #: CD20-0703
• Status: Completed
• Phase: Phase 1
• First received: March 31, 2010
• Last updated: April 27, 2012
• Start date: November 2008
• Est. completion date: August 2011

Study information

• Verified date: April 2012
• Source: Laboratoire français de Fractionnement et de Biotechnologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• LFB-R603
intravenous administration, dose-escalation study

Locations

Country	Name	City	State
France	Clinique Victor Hugo	Le Mans
France	Hôpital Hurriez	Lille
France	Institut Paoli Calmettes	Marseille
France	Hôpital Saint Eloi	Montpellier
France	CH Lyon Sud	Pierre Bénite
France	Hôpital Pontchaillou	Rennes
France	Centre Henri Becquerel	Rouen
France	Hôpital de Brabois	Vandoeuvre Les Nancy
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoire français de Fractionnement et de Biotechnologies

Country where clinical trial is conducted

France, 

References & Publications (1)

de Romeuf C, Dutertre CA, Le Garff-Tavernier M, Fournier N, Gaucher C, Glacet A, Jorieux S, Bihoreau N, Behrens CK, Béliard R, Vieillard V, Cazin B, Bourel D, Prost JF, Teillaud JL, Merle-Béral 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes