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

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label
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

Resource links provided by NLM:

MedlinePlus related topics: Acute Lymphocytic Leukemia Chronic Lymphocytic Leukemia Leukemia

Drug Information available for: Lumiliximab

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	70
Study Start Date:	September 2002
Study Completion Date:	March 2010
Primary Completion Date:	April 2004 (Final data collection date for primary outcome measure)

Intervention Details:

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

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

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.

Responsible Party:	Study MD, Biogen Idec
ClinicalTrials.gov Identifier:	NCT00046488 History of Changes
Other Study ID Numbers:	152-20
Study First Received:	September 30, 2002
Last Updated:	July 29, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biogen Idec:

Chronic Lymphoblastic Leukemia
Leukemia, Lymphoblastic, Chronic
Chronic Lymphocytic Leukemia
CLL

Additional relevant MeSH terms:

Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms

Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012