Study of ONTAK in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL)
A Multicenter, Phase II Study of ONTAK (Denileukin Diftitox) in Patients With Previously-Treated Chronic Lymphocytic Leukemia
1 other identifier
interventional
41
5 countries
14
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2003
Typical duration for phase_2
14 active sites
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
First Submitted
Initial submission to the registry
February 19, 2003
CompletedFirst Posted
Study publicly available on registry
February 21, 2003
CompletedStudy Start
First participant enrolled
March 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedApril 17, 2009
April 1, 2009
3 years
February 19, 2003
April 16, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Clinical Response
Secondary Outcomes (2)
Time-to-Progression
Duration of response
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Prior treatment with ONTAK (DAB389IL-2) or DAB486IL-2.
- Received any therapy for CLL within 35 days prior to study entry.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
Study Sites (14)
Pacific Coast Hematology/Oncology Medical Group, Inc.
Fountain Valley, California, 92708, United States
UCSD School of Medicine
La Jolla, California, 92093-0663, United States
Rush-Presbyterian St. Luke's Cancer Center
Chicago, Illinois, 60612, United States
Weill Medical College of Cornell University/New York Presbyterian Hospital
New York, New York, 10021, United States
University of Texas, M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Montecaseros
Mendoza, 5500, Argentina
Peter MacCallum Cancer Institute
East Melbourne, Victoria, 3002, Australia
Oncology Day Unit, Frankston Hospital
Frankston, 3199, Australia
Hospital Araujo Jorge - Associacao de Combate ao Cancer em Goias
Goiânia, Goiás, 74605-070, Brazil
Hospital de Clinicas da Universidade Federal do Parana
Curitiba, Paraná, 80060-900, Brazil
Universidade Federal do Rio de Janeiro - Hospital Universitario Clementino Fraga Filho
Rio de Janeiro, Rio de Janeiro, 21941-590, Brazil
Hospital de Cancer de Barretos - Fundacao Pio XII
Barretos, São Paulo, 14784-400, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, 05403-000, Brazil
Sir Mortimer B. Davis - Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Elyane Lombardy, M.D.
Ligand Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 19, 2003
First Posted
February 21, 2003
Study Start
March 1, 2003
Primary Completion
March 1, 2006
Study Completion
May 1, 2006
Last Updated
April 17, 2009
Record last verified: 2009-04