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

September 12, 2013 updated by: Biogen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States
        • Research Site
      • LaJolla, California, United States
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States
        • Research Site
    • New York
      • New Hyde Park, New York, United States
        • Research Site
      • New York, New York, United States
        • Research Site
    • Ohio
      • Columbus, Ohio, United States
        • Research Site
    • Texas
      • Houston, Texas, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine a recommended Phase II dose for the treatment of patients with relapsed or refractory CLL
Time Frame: 48 months
48 months
Characterize the safety profile of IDEC-152
Time Frame: 48 months
48 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate the pharmacokinetics and pharmacodynamics of IDEC-152 in patients with relapsed or refractory CLL
Time Frame: 48 months
48 months
Evaluate the efficacy of IDEC-152 in patients with relapsed or refractory CLL
Time Frame: 48 months
48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (Actual)

April 1, 2004

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

September 30, 2002

First Submitted That Met QC Criteria

October 1, 2002

First Posted (Estimate)

October 2, 2002

Study Record Updates

Last Update Posted (Estimate)

September 16, 2013

Last Update Submitted That Met QC Criteria

September 12, 2013

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 152-20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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