NCT00019032

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1 leukemia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1996

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2004

First QC Date

July 11, 2001

Last Update Submit

April 27, 2015

Conditions

Leukemia

Keywords

refractory chronic lymphocytic leukemiaT-cell large granular lymphocyte leukemia

Interventions

monoclonal antibody Mik-beta-1BIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Large Granular Lymphocytic

Interventions

Hu-Mik-beta-1 monoclonal antibody

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, B-CellLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, T-Cell

Study Officials

  • Thomas A. Waldmann, MD

    NCI - Metabolism Branch;MET

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

July 11, 2001

First Posted

January 27, 2003

Study Start

March 1, 1996

Last Updated

April 28, 2015

Record last verified: 2004-04

Locations

US(1)