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

This study has been completed.

Sponsor:

Information provided by:

Eisai Inc.

ClinicalTrials.gov Identifier:

NCT00055146

First received: February 19, 2003

Last updated: April 16, 2009

Last verified: April 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

February 19, 2003

Last Updated Date

April 16, 2009

Start Date ^ICMJE

March 2003

Primary Completion Date

March 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Objective Clinical Response

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00055146 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Time-to-Progression
Duration of response

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Multicenter, Phase II Study of ONTAK (Denileukin Diftitox) in Patients With Previously-Treated Chronic Lymphocytic Leukemia

Brief Summary

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Leukemia, Lymphocytic, Chronic

Intervention ^ICMJE

Drug: ONTAK

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

May 2006

Primary Completion Date

March 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Australia, Brazil, Canada

Administrative Information

NCT Number ^ICMJE

NCT00055146

Other Study ID Numbers ^ICMJE

L4389-34

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Eisai Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Elyane Lombardy, M.D.

Ligand Pharmaceuticals

Information Provided By

Eisai Inc.

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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