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

Sponsor

Biogen (Industry)

Overall Status

Completed

CT.gov ID

NCT00046488

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Sep 1, 2002

Actual Primary Completion Date :

Apr 1, 2004

Actual Study Completion Date :

Mar 1, 2010

Outcome Measures

Primary Outcome Measures

Determine a recommended Phase II dose for the treatment of patients with relapsed or refractory CLL [48 months]
Characterize the safety profile of IDEC-152 [48 months]

Secondary Outcome Measures

Evaluate the pharmacokinetics and pharmacodynamics of IDEC-152 in patients with relapsed or refractory CLL [48 months]
Evaluate the efficacy of IDEC-152 in patients with relapsed or refractory CLL [48 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country
1	Research Site	La Jolla	California	United States
2	Research Site	LaJolla	California	United States
3	Research Site	Baltimore	Maryland	United States
4	Research Site	New Hyde Park	New York	United States
5	Research Site	New York	New York	United States
6	Research Site	Columbus	Ohio	United States
7	Research Site	Houston	Texas	United States