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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2010-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Lymphocytic Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Lumiliximab

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No