Safety and Efficacy of IDEC-152 in the Treatment of Chronic Lymphocytic Leukemia (CLL) - Tabular View

Tracking Information
First Received Date ^ICMJE	September 30, 2002
Last Updated Date	July 10, 2009
Start Date ^ICMJE	September 2002
Primary Completion Date	April 2004 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 5, 2009)	Determine a recommended Phase II dose for the treatment of patients with relapsed or refractory CLL [ Time Frame: 48 months ] [ Designated as safety issue: No ] Characterize the safety profile of IDEC-152 [ Time Frame: 48 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: September 7, 2005)	Determine a recommended Phase II dose for the treatment of patients with relapsed or refractory CLL Characterize the safety profile of IDEC-152
Change History	Complete list of historical versions of study NCT00046488 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 5, 2009)	Evaluate the pharmacokinetics and pharmacodynamics of IDEC-152 in patients with relapsed or refractory CLL [ Time Frame: 48 months ] [ Designated as safety issue: No ] Evaluate the efficacy of IDEC-152 in patients with relapsed or refractory CLL [ Time Frame: 48 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: September 7, 2005)	Evaluate the pharmacokinetics and pharmacodynamics of IDEC-152 in patients with relapsed or refractory CLL Evaluate the efficacy of IDEC-152 in patients with relapsed or refractory CLL

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy of IDEC-152 in the Treatment of Chronic Lymphocytic Leukemia (CLL)
Official Title ^ICMJE	A Phase I Multicenter, Dose-Escalation Study of IDEC-152 (Anti-CD23 Monoclonal Antibody) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Brief Summary	To determine what side effects and what clinical effects if any the administration of this investigational product, IDEC-152 (an antibody against CD23 which is an important protein on leukemia cells and certain cells in the body's immune system), has on the CLL patient population.
Detailed Description
Study Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Other, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Chronic Lymphocytic Leukemia
Intervention ^ICMJE	Drug: IDEC-152
Study Arms / Comparison Groups
Publications *	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. 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. Epub 2007 Nov 21.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	70
Estimated Completion Date	December 2010
Primary Completion Date	April 2004 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Signed IRB-approved informed consent. 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: Previous exposure to IDEC-152 or other anti-CD23 antibodies 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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00046488
Responsible Party	Study MD, Biogen Idec
Study ID Numbers ^ICMJE	152-20
Study Sponsor ^ICMJE	Biogen Idec
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Biogen Idec
Verification Date	July 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP