Study of ONTAK in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL)
Completed · Phase 2
Conditions studied: Leukemia, Lymphocytic, Chronic
In brief
The purpose of this study is to evaluate the safety and effectiveness of ONTAK in previously treated patients with chronic lymphocytic leukemia (CLL)
Key facts
- Study ID
- NCT00055146
- Run by
- Eisai Inc.
- People needed
- 41
- Starts
- 2003-03-01
- Expected to finish
- 2006-05-01
- Last updated by the study team
- 2009-04-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Pacific Coast Hematology/Oncology Medical Group, Inc. — Fountain Valley, California, United States
- UCSD School of Medicine — La Jolla, California, United States
- Rush-Presbyterian St. Luke's Cancer Center — Chicago, Illinois, United States
- Weill Medical College of Cornell University/New York Presbyterian Hospital — New York, New York, United States
- University of Texas, M.D. Anderson Cancer Center — Houston, Texas, United States
- Montecaseros — Mendoza, Argentina
- Peter MacCallum Cancer Institute — East Melbourne, Victoria, Australia
- Oncology Day Unit, Frankston Hospital — Frankston, Australia
- Hospital Araujo Jorge - Associacao de Combate ao Cancer em Goias — Goiânia, Goiás, Brazil
- Hospital de Clinicas da Universidade Federal do Parana — Curitiba, Paraná, Brazil
- Universidade Federal do Rio de Janeiro - Hospital Universitario Clementino Fraga Filho — Rio de Janeiro, Rio de Janeiro, Brazil
- Hospital de Cancer de Barretos - Fundacao Pio XII — Barretos, São Paulo, Brazil
- Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo — São Paulo, São Paulo, Brazil
- Sir Mortimer B. Davis - Jewish General Hospital — Montreal, Quebec, Canada
Full record on ClinicalTrials.gov
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