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PHASE I STUDY OF T-CELL LARGE GRANULAR LYMPHOCYTIC LEUKEMIA USING THE MIK-BETA 1 MONOCLONAL ANTIBODY DIRECTED TOWARD THE IL-2R BETA SUBUNIT


Phase 1
18 Years
N/A
Not Enrolling
Both
Leukemia

Thank you

Trial Information

PHASE I STUDY OF T-CELL LARGE GRANULAR LYMPHOCYTIC LEUKEMIA USING THE MIK-BETA 1 MONOCLONAL ANTIBODY DIRECTED TOWARD THE IL-2R BETA SUBUNIT


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Thomas A. Waldmann, MD

Investigator Role:

Study Chair

Investigator Affiliation:

NCI - Metabolism Branch;MET

Authority:

United States: Federal Government

Study ID:

CDR0000064038

NCT ID:

NCT00019032

Start Date:

March 1996

Completion Date:

Related Keywords:

  • Leukemia
  • refractory chronic lymphocytic leukemia
  • T-cell large granular lymphocyte leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Leukemia, Large Granular Lymphocytic

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182