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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00046488

Enrollment

Registered

2002-10-02

Start date

2002-09-30

Completion date

2010-03-31

Last updated

2013-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia

Keywords

Chronic Lymphoblastic Leukemia, Leukemia, Lymphoblastic, Chronic, Chronic Lymphocytic Leukemia, CLL

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.

Interventions

DRUGIDEC-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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026