LFB-R603 Dose Finding in Patients With Advanced Stage B-Chronic Lymphocytic Leukemia
NCT ID: NCT01098188
Last Updated: 2012-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
33 participants
INTERVENTIONAL
2008-11-30
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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LFB-R603
intravenous administration, dose-escalation study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Laboratoire français de Fractionnement et de Biotechnologies
INDUSTRY
Responsible Party
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LFB Biotechnologies
Principal Investigators
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Vincent RIBRAG, MD
Role: PRINCIPAL_INVESTIGATOR
Locations
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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
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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References
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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.
Other Identifiers
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CD20-0703
Identifier Type: -
Identifier Source: org_study_id