Clinical trial NCT01098188: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Lymphocytic Leukemia
Lead sponsor: Laboratoire français de Fractionnement et de Biotechnologies
Sponsor class: INDUSTRY
First posted: 2010-04-02
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: on going
Secondary outcomes:
Other outcomes:
Locations:
city: Le Mans
country: France
facility: Clinique Victor Hugo
city: Lille
country: France
facility: Hôpital Hurriez
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Montpellier
country: France
facility: Hôpital Saint Eloi
city: Pierre Bénite
country: France
facility: CH Lyon Sud
city: Rennes
country: France
facility: Hôpital Pontchaillou
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Vandoeuvre Les Nancy
country: France
facility: Hôpital de Brabois
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
name: Vincent RIBRAG, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.