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NCT00046488 Clinical Trial

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

Chronic Lymphocytic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00046488
Other study ID # 152-20
Secondary ID
Status Completed
Phase Phase 1
First received September 30, 2002
Last updated September 12, 2013
Start date September 2002
Est. completion date March 2010

Study information
Verified date May 2010
Source Biogen
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date March 2010
Est. primary completion date April 2004
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Research Site Baltimore Maryland
United States Research Site Columbus Ohio
United States Research Site Houston Texas
United States Research Site La Jolla California
United States Research Site LaJolla California
United States Research Site New Hyde Park New York
United States Research Site New York New York

Sponsors (1)
Lead Sponsor Collaborator
Biogen

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Determine a recommended Phase II dose for the treatment of patients with relapsed or refractory CLL 48 months No
Primary Characterize the safety profile of IDEC-152 48 months Yes
Secondary Evaluate the pharmacokinetics and pharmacodynamics of IDEC-152 in patients with relapsed or refractory CLL 48 months No
Secondary Evaluate the efficacy of IDEC-152 in patients with relapsed or refractory CLL 48 months No
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