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CompletedNCT00019032Updated Apr 28, 2015

Monoclonal Antibody Therapy in Treating Patients With Chronic Lymphocytic Leukemia

A Phase 1 interventional study of monoclonal antibody Mik-beta-1 in Leukemia, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-28.

Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
25
Ages
18 Years and older
Sex
All
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Study summary

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-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 chronic lymphocytic leukemia.

Read the detailed description

OBJECTIVES:

  • Evaluate the toxicity of murine monoclonal antibody Mik-beta-1 (MOAB Mik-beta-1) in patients with T-cell large granular lymphocytic leukemia associated with granulocytopenia, anemia, or thrombocytopenia.
  • Determine the clinical response in patients treated with this drug.
  • Assess the effect of this drug on the number of circulating CD3+, CD8+ expressing granular lymphocytes and the number of polymorphonuclear leukocytes, red blood cells, and platelets in this patient population.
  • Monitor patients for the time course of decline in circulating infused MOAB Mik-beta-1 and for the production of human antibodies to IV infused murine MOAB Mik-beta-1.

OUTLINE: This is a dose-escalation study.

Patients receive monoclonal antibody Mik-beta-1 (MOAB Mik-beta-1) IV over 2 hours on days 1, 4, 7, and 10. Patients achieving a complete response (CR) or partial response (PR) may receive 1 additional course beginning no sooner than 4 weeks after completion of the first course, in the absence of antibodies to MOAB Mik-beta-1. Treatment continues in the absence of disease progression, unacceptable toxicity, or severe allergic reaction.

Cohorts of 3-6 patients receive escalating doses of MOAB Mik-beta-1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at 6-10 days and at 4-6 weeks after therapy. Patients with a PR or CR may be followed every 6 months for 2 years or until relapse. All patients are followed for survival.

PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for this study.

02

Conditions studied

  • Leukemia

Keywords

  • refractory chronic lymphocytic leukemia
  • T-cell large granular lymphocyte leukemia
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's planned enrollment of 25 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed T-cell large granular lymphocytic (T-LGL) leukemia associated with clinically significant hematocytopenia demonstrated by one of the following values while off growth factor support:

    • Absolute neutrophil count less than 1,000/mm\^3
    • Hemoglobin less than 8 g/dL
    • Platelet count less than 50,000/mm\^3
  • Clinically evaluable disease with peripheral blood T-LGL leukemia cells expressing the CD3+, CD8+ phenotype detectable by FACS
  • Monoclonal T-cell population in peripheral blood (circulating mononuclear cells) demonstrated by TCR beta or gamma chain gene rearrangement

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 50-100%

Life expectancy:

  • More than 2 months

Hematopoietic:

  • See Disease Characteristics
  • No active major bleeding episode within the past 4 weeks

Hepatic:

  • Direct bilirubin less than 1.5 mg/dL

Renal:

  • Creatinine less than 2.0 mg/dL

Other:

  • No concurrent serious active infection
  • Patients with fever without apparent site of infection may begin study while on antibiotics as long as the following are true:

    • No pathogenic organism in culture
    • Afebrile (maximum temperature less than 38°C) for at least 5 days
  • HIV negative
  • No other primary cancer other than basal cell skin cancer
  • Not pregnant or nursing
  • Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior interferon
  • Concurrent filgrastim (G-CSF), sargramostim (GM-CSF), interleukin-11, or similar sustained-release/long-acting product (e.g., pegylated G-CSF) allowed if dose established at least 4 weeks prior to study participation
  • No concurrent interferon

Chemotherapy:

  • At least 4 weeks since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy:

  • Concurrent corticosteroids allowed if dose established at least 3 weeks prior to study participation

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • At least 1 week since completion of prior antibiotic regimen for serious infectious episode
  • No other concurrent investigational drugs
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Enrollment
25 participants (estimated)

Interventions

  • Biologicalmonoclonal antibody Mik-beta-1
06

Study locations

1 site
  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
    Bethesda, Maryland 20892-1182, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00019032
Lead sponsor
National Cancer Institute (NCI)
First posted
Jan 27, 2003
Start date
Mar 1996
Last update
Apr 28, 2015

Study contacts

Thomas A. Waldmann, MD
study chair · NCI - Metabolism Branch;MET
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2004. You cannot join it, but the record below documents what was studied.

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