Expired Study
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LaJolla, California


Purpose:

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.


Criteria:

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:

152-20


NCT ID:

NCT00046488


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:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


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:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

70


Enrollment Type:

Actual


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
Name:IDEC-152
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.
PMID:18032710
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.
PMID:17671129

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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