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OpenTrials
Completed

NCT Number: NCT00046488

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

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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Key information

Conditions

Chronic Lymphocytic Leukemia Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, La Jolla, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IDEC-152

Drug

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

Other names: Lumiliximab

Primary outcomes

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

    Time frame: 48 months

  2. Characterize the safety profile of IDEC-152

    Time frame: 48 months

Secondary outcomes

  1. Evaluate the pharmacokinetics and pharmacodynamics of IDEC-152 in patients with relapsed or refractory CLL

    Time frame: 48 months

  2. Evaluate the efficacy of IDEC-152 in patients with relapsed or refractory CLL

    Time frame: 48 months

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2004
Study completion
2010
First posted
Oct 2, 2002
Registry last updated
Sep 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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