LFB-R603 Dose Finding in Patients With Advanced Stage B-C... | NCT01098188

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

NCT01098188

Sponsor

Laboratoire français de Fractionnement et de Biotechnologies

Status

Completed

Last Update Posted

Apr 30, 2012Estimated

Enrollment

33Actual

Phase

Phase 1

Conditions

Chronic Lymphocytic Leukemia

Interventions

LFB-R603

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Mar 31, 2010

First Submission Date that Met QC Criteria

Apr 1, 2010

First Posted Date

Apr 2, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2012

Last Update Posted Date

Apr 30, 2012Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Name	Type	Description	Arm Group Labels	Other Names
LFB-R603	Drug	intravenous administration, dose-escalation study		ublituximab

Measure	Description	Time Frame
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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Vincent RIBRAG, MD		Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Clinique Victor Hugo		Le Mans		72000	France
Hôpital Hurriez

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18302712	Background	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.

ID	Term
D015448	Leukemia, B-Cell
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type