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Clinical Trials/NCT00046488
NCT00046488CompletedPhase 1

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

Biogen6 sites in 1 country70 target enrollmentStarted: September 1, 2002Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Biogen
Enrollment
70
Locations
6
Primary Endpoint
Determine a recommended Phase II dose for the treatment of patients with relapsed or refractory CLL
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Determine a recommended Phase II dose for the treatment of patients with relapsed or refractory CLL

Time Frame: 48 months

Characterize the safety profile of IDEC-152

Time Frame: 48 months

Secondary Outcomes

  • 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)

Investigators

Sponsor
Biogen
Sponsor Class
Industry

Study Sites (6)

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