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Monoclonal Antibody in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

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ClinicalTrials.gov Identifier: NCT00058396
Recruitment Status : Completed
First Posted : April 9, 2003
Last Update Posted : May 30, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Biological: lumiliximab Phase 1

Detailed Description:


  • Determine a recommended phase II dose of IDEC-152 monoclonal antibody in patients with relapsed or recurrent chronic lymphocytic leukemia.
  • Determine the safety profile of this drug in these patients.
  • Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
  • Determine the efficacy of this drug in these patients.

OUTLINE: This is an open-label, multicenter, dose-escalation study.

Patients receive IDEC-152 monoclonal antibody IV over at least 2 hours on days 1, 2, 8, 15, and 22.

Cohorts of 3-10 patients receive escalating doses of IDEC-152 monoclonal antibody until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3, 2 of 6, or 3 of 10 patients experience dose-limiting toxicity.

Patients are followed every 3 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 15-50 patients will be accrued for this study within 6 months.

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study Of IDEC-152 (Anti-CD23 Monoclonal Antibody) In Patients With Relapsed Or Refractory Chronic Lymphocytic Leukemia
Study Start Date : October 2002
Primary Completion Date : October 2004

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed chronic lymphocytic leukemia OR small lymphocytic lymphoma

    • Stage III-IV OR
    • Stage I-II, if determined to have disease progression evidenced by 1 of the following characteristics:

      • Rapid doubling of peripheral lymphocyte count
      • Progressive lymphadenopathy
      • Progressive splenomegaly
      • B symptoms
      • Grade 2 or 3 fatigue
  • CD23+ disease
  • Progressive disease after at least 1 prior chemotherapy course



  • 18 and over

Performance status

  • WHO 0-2

Life expectancy

  • At least 6 months


  • Platelet count at least 50,000/mm^3


  • Bilirubin no greater than 2.0 mg/dL
  • AST/ALT no greater than 1.5 times upper limit of normal (ULN)


  • Creatinine no greater than 1.5 times ULN


  • No New York Heart Association class III or IV cardiac disease
  • No myocardial infarction within the past 6 months
  • No unstable arrhythmia
  • No evidence of ischemia on EKG within the past 14 days


  • FEV_1 at least 60% of predicted
  • DLCO at least 55% of predicted


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study treatment
  • HIV negative
  • No secondary malignancy requiring active treatment (except hormonal therapy)
  • No serious nonmalignant disease that would preclude study participation
  • No active uncontrolled bacterial, viral, or fungal infection
  • No clinically active autoimmune disease


Biologic therapy

  • More than 4 weeks since prior anticancer biologic therapy
  • More than 4 weeks since prior anticancer radioimmunotherapy
  • No prior exposure to IDEC-152 or anti-CD23 antibodies


  • See Disease Characteristics
  • More than 4 weeks since prior anticancer chemotherapy

Endocrine therapy

  • Concurrent hormonal therapy allowed for second malignancy


  • More than 4 weeks since prior anticancer radiotherapy


  • More than 4 weeks since prior major surgery (except for diagnostic surgery)


  • More than 4 weeks since prior anticancer investigational therapy
  • No other concurrent anticancer therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00058396

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Mark Adam Weiss, MD Memorial Sloan Kettering Cancer Center

ClinicalTrials.gov Identifier: NCT00058396     History of Changes
Other Study ID Numbers: IDEC-152-20
CDR0000288828 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: April 9, 2003    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: December 2009

Keywords provided by National Cancer Institute (NCI):
refractory chronic lymphocytic leukemia
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
noncontiguous stage II small lymphocytic lymphoma
recurrent small lymphocytic lymphoma
stage I small lymphocytic lymphoma
stage III small lymphocytic lymphoma
stage IV small lymphocytic lymphoma
contiguous stage II small lymphocytic lymphoma

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs