Study of ONTAK in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL)

NCT ID: NCT00055146

Last Updated: 2009-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2006-05-31

Brief Summary

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The purpose of this study is to evaluate the safety and effectiveness of ONTAK in previously treated patients with chronic lymphocytic leukemia (CLL)

Detailed Description

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Conditions

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Leukemia, Lymphocytic, Chronic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ONTAK

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with B-cell Chronic Lymphocytic Leukemia, Rai Stage 0-II with indication for treatment by NCI Working Group Criteria or Rai Stage III or IV.
* Patients must have received at least one prior purine analogue-based chemotherapy regimen.
* ECOG Performance Status of 0, 1, or 2.
* Female patients cannot be pregnant and must use birth control during the course of the study and for three weeks after the study ends.

Exclusion Criteria

* Prior treatment with ONTAK (DAB389IL-2) or DAB486IL-2.
* Received any therapy for CLL within 35 days prior to study entry.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Inc.

INDUSTRY

Sponsor Role lead

Principal Investigators

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Elyane Lombardy, M.D.

Role: STUDY_DIRECTOR

Ligand Pharmaceuticals

Locations

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Pacific Coast Hematology/Oncology Medical Group, Inc.

Fountain Valley, California, United States

Site Status

UCSD School of Medicine

La Jolla, California, United States

Site Status

Rush-Presbyterian St. Luke's Cancer Center

Chicago, Illinois, United States

Site Status

Weill Medical College of Cornell University/New York Presbyterian Hospital

New York, New York, United States

Site Status

University of Texas, M.D. Anderson Cancer Center

Houston, Texas, United States

Site Status

Montecaseros

Mendoza, , Argentina

Site Status

Peter MacCallum Cancer Institute

East Melbourne, Victoria, Australia

Site Status

Oncology Day Unit, Frankston Hospital

Frankston, , Australia

Site Status

Hospital Araujo Jorge - Associacao de Combate ao Cancer em Goias

Goiânia, Goiás, Brazil

Site Status

Hospital de Clinicas da Universidade Federal do Parana

Curitiba, Paraná, Brazil

Site Status

Universidade Federal do Rio de Janeiro - Hospital Universitario Clementino Fraga Filho

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Hospital de Cancer de Barretos - Fundacao Pio XII

Barretos, São Paulo, Brazil

Site Status

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Sir Mortimer B. Davis - Jewish General Hospital

Montreal, Quebec, Canada

Site Status

Countries

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United States Argentina Australia Brazil Canada

Other Identifiers

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L4389-34

Identifier Type: -

Identifier Source: org_study_id

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