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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00046488
Recruitment Status : Completed
First Posted : October 2, 2002
Last Update Posted : September 16, 2013
Sponsor:
Information provided by:
Biogen

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.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: IDEC-152 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2002
Primary Completion Date : April 2004
Study Completion Date : March 2010



Intervention Details:
    Drug: IDEC-152
    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


Primary Outcome Measures :
  1. Determine a recommended Phase II dose for the treatment of patients with relapsed or refractory CLL [ Time Frame: 48 months ]
  2. Characterize the safety profile of IDEC-152 [ Time Frame: 48 months ]

Secondary Outcome Measures :
  1. Evaluate the pharmacokinetics and pharmacodynamics of IDEC-152 in patients with relapsed or refractory CLL [ Time Frame: 48 months ]
  2. Evaluate the efficacy of IDEC-152 in patients with relapsed or refractory CLL [ Time Frame: 48 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Study MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00046488     History of Changes
Other Study ID Numbers: 152-20
First Posted: October 2, 2002    Key Record Dates
Last Update Posted: September 16, 2013
Last Verified: May 2010

Keywords provided by Biogen:
Chronic Lymphoblastic Leukemia
Leukemia, Lymphoblastic, Chronic
Chronic Lymphocytic Leukemia
CLL

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell