Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

LaJolla, California


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.


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

Study is Available At:

Original ID:




Secondary ID:

Study Acronym:

Brief Title:

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

Official Title:

A Phase I Multicenter, Dose-Escalation Study of IDEC-152 (Anti-CD23 Monoclonal Antibody) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Overall Status:


Study Phase:

Phase 1



Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Biogen Idec

Oversight Authority:

United States: Food and Drug Administration

Reasons Why Stopped:

Study Type:


Study Design:

Allocation: Randomized, Endpoint Classification:

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Study Dates

Start Date:September 2002
Completion Date:March 2010
Completion Type:Actual
Primary Completion Date:April 2004
Primary Completion Type:Actual
Verification Date:May 2010
Last Changed Date:September 12, 2013
First Received Date:September 30, 2002

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Evaluate the efficacy of IDEC-152 in patients with relapsed or refractory CLL
Time Frame:48 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Evaluate the pharmacokinetics and pharmacodynamics of IDEC-152 in patients with relapsed or refractory CLL
Time Frame:48 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Characterize the safety profile of IDEC-152
Time Frame:48 months
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Determine a recommended Phase II dose for the treatment of patients with relapsed or refractory CLL
Time Frame:48 months
Safety Issues:False

Study Interventions

Intervention Type:Drug
Description: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 Name:Lumiliximab

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Biogen Idec

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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.
Reference Type:Reference
Citation: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.

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

This study is not currently recruiting Study Participants. The form below is not enabled.