Safety and Efficacy of IDEC-152 in the Treatment of Chronic Lymphocytic Leukemia (CLL)
NCT ID: NCT00046488
Last Updated: 2013-09-16
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
70 participants
INTERVENTIONAL
2002-09-30
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
NONE
Interventions
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IDEC-152
6 Dosing groups: 125mg/m2 weekly x 4, 250mg/m2 weekly x 4, 375mg/m2 weekly x 4, 500mg/m2 weekly x 4, 500mg/m2 3 times first week then weekly x 3, 500mg/m2 3 times per week x 4
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Greater than 18 years of age
* Proof of CD23+ CLL or small lymphocytic lymphoma (SLL)
* Progressive disease after at least 1 course of chemotherapy
* Acceptable hematologic status, liver function, renal function, and pulmonary function
* Patients of reproductive potential must agree to follow accepted birth control methods during treatment and for 3 months after completion of treatment
Exclusion Criteria
* Presence of HIV infection or AIDS
* Serious nonmalignant disease
* Active uncontrolled bacterial, viral or fungal infections.
* Clinically active autoimmune disease
* Pregnant or currently breast feeding
18 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Biogen Idec
Locations
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Research Site
La Jolla, California, United States
Research Site
Baltimore, Maryland, United States
Research Site
New Hyde Park, New York, United States
Research Site
New York, New York, United States
Research Site
Columbus, Ohio, United States
Research Site
Houston, Texas, United States
Countries
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References
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Byrd JC, O'Brien S, Flinn IW, Kipps TJ, Weiss M, Rai K, Lin TS, Woodworth J, Wynne D, Reid J, Molina A, Leigh B, Harris S. Phase 1 study of lumiliximab with detailed pharmacokinetic and pharmacodynamic measurements in patients with relapsed or refractory chronic lymphocytic leukemia. Clin Cancer Res. 2007 Aug 1;13(15 Pt 1):4448-55. doi: 10.1158/1078-0432.CCR-06-1463.
Pathan NI, Chu P, Hariharan K, Cheney C, Molina A, Byrd J. Mediation of apoptosis by and antitumor activity of lumiliximab in chronic lymphocytic leukemia cells and CD23+ lymphoma cell lines. Blood. 2008 Feb 1;111(3):1594-602. doi: 10.1182/blood-2007-03-082024. Epub 2007 Nov 21.
Other Identifiers
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152-20
Identifier Type: -
Identifier Source: org_study_id