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

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.

Condition	Intervention	Phase
Chronic Lymphocytic Leukemia	Drug: IDEC-152	Phase I

MedlinePlus related topics:

Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for:

Lumiliximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Other, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

Characterize the safety profile of IDEC-152
Determine a recommended Phase II dose for the treatment of patients with relapsed or refractory CLL

Secondary Outcome Measures:

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

Estimated Enrollment:	70
Study Start Date:	September 2002

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00046488

Locations


United States, California
	Research Site
	La Jolla, California, United States
	Research Site
	LaJolla, California, United States

United States, Maryland
	Research Site
	Baltimore, Maryland, United States

United States, New York
	Research Site
	New York, New York, United States
	Research Site
	New Hyde Park, New York, United States

United States, Ohio
	Research Site
	Columbus, Ohio, United States

United States, Texas
	Research Site
	Houston, Texas, United States

Sponsors and Collaborators

Biogen Idec

More Information

Publications of Results:

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.

Other Publications:

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.

Study ID Numbers:	152-20
First Received:	September 30, 2002
Last Updated:	April 4, 2008
ClinicalTrials.gov Identifier:	NCT00046488
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biogen Idec:

Chronic Lymphocytic Leukemia

Chronic Lymphoblastic Leukemia

Leukemia, Lymphoblastic, Chronic

CLL

Study placed in the following topic categories:

Antibodies, Monoclonal

Chronic lymphocytic leukemia

Lymphatic Diseases

Leukemia

Antibodies

Leukemia, Lymphoid

Immunoproliferative Disorders

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, B-cell, chronic

Lymphoproliferative Disorders

Leukemia, B-Cell

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Immune System Diseases

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	Biogen Idec
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00046488