Back to resultsStudy of ONTAK in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL)
Primary Purpose
Leukemia, Lymphocytic, Chronic
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ONTAK
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia, Lymphocytic, Chronic
Eligibility Criteria
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.
Sites / Locations
- Pacific Coast Hematology/Oncology Medical Group, Inc.
- UCSD School of Medicine
- Rush-Presbyterian St. Luke's Cancer Center
- Weill Medical College of Cornell University/New York Presbyterian Hospital
- University of Texas, M.D. Anderson Cancer Center
- Montecaseros
- Peter MacCallum Cancer Institute
- Oncology Day Unit, Frankston Hospital
- Hospital Araujo Jorge - Associacao de Combate ao Cancer em Goias
- Hospital de Clinicas da Universidade Federal do Parana
- Universidade Federal do Rio de Janeiro - Hospital Universitario Clementino Fraga Filho
- Hospital de Cancer de Barretos - Fundacao Pio XII
- Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
- Sir Mortimer B. Davis - Jewish General Hospital
Outcomes
Primary Outcome Measures
Objective Clinical Response
Secondary Outcome Measures
Time-to-Progression
Duration of response
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00055146
Brief Title
Study of ONTAK in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL)
Official Title
A Multicenter, Phase II Study of ONTAK (Denileukin Diftitox) in Patients With Previously-Treated Chronic Lymphocytic Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eisai Inc.
4. Oversight
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphocytic, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ONTAK
Primary Outcome Measure Information:
Title
Objective Clinical Response
Secondary Outcome Measure Information:
Title
Time-to-Progression
Title
Duration of response
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elyane Lombardy, M.D.
Organizational Affiliation
Ligand Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Pacific Coast Hematology/Oncology Medical Group, Inc.
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
UCSD School of Medicine
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0663
Country
United States
Facility Name
Rush-Presbyterian St. Luke's Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Weill Medical College of Cornell University/New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
University of Texas, M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Montecaseros
City
Mendoza
ZIP/Postal Code
5500
Country
Argentina
Facility Name
Peter MacCallum Cancer Institute
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Oncology Day Unit, Frankston Hospital
City
Frankston
ZIP/Postal Code
3199
Country
Australia
Facility Name
Hospital Araujo Jorge - Associacao de Combate ao Cancer em Goias
City
Goiania
State/Province
GO
ZIP/Postal Code
74605-070
Country
Brazil
Facility Name
Hospital de Clinicas da Universidade Federal do Parana
City
Curitiba
State/Province
PR
ZIP/Postal Code
80060-900
Country
Brazil
Facility Name
Universidade Federal do Rio de Janeiro - Hospital Universitario Clementino Fraga Filho
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21941-590
Country
Brazil
Facility Name
Hospital de Cancer de Barretos - Fundacao Pio XII
City
Barretos
State/Province
SP
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Sir Mortimer B. Davis - Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Study of ONTAK in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL)
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