Study of ONTAK in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL)
This study has been completed.
Sponsor:
Eisai Inc.
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00055146
First received: February 19, 2003
Last updated: April 16, 2009
Last verified: April 2009
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Purpose
The purpose of this study is to evaluate the safety and effectiveness of ONTAK in previously treated patients with chronic lymphocytic leukemia (CLL)
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia, Lymphocytic, Chronic |
Drug: ONTAK |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter, Phase II Study of ONTAK (Denileukin Diftitox) in Patients With Previously-Treated Chronic Lymphocytic Leukemia |
Resource links provided by NLM:
Further study details as provided by Eisai Inc.:
Primary Outcome Measures:
- Objective Clinical Response
Secondary Outcome Measures:
- Time-to-Progression
- Duration of response
| Estimated Enrollment: | 41 |
| Study Start Date: | March 2003 |
| Study Completion Date: | May 2006 |
| Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00055146
Locations
| United States, California | |
| Pacific Coast Hematology/Oncology Medical Group, Inc. | |
| Fountain Valley, California, United States, 92708 | |
| UCSD School of Medicine | |
| La Jolla, California, United States, 92093-0663 | |
| United States, Illinois | |
| Rush-Presbyterian St. Luke's Cancer Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, New York | |
| Weill Medical College of Cornell University/New York Presbyterian Hospital | |
| New York, New York, United States, 10021 | |
| United States, Texas | |
| University of Texas, M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Argentina | |
| Montecaseros | |
| Mendoza, Argentina, 5500 | |
| Australia, Victoria | |
| Peter MacCallum Cancer Institute | |
| East Melbourne, Victoria, Australia, 3002 | |
| Australia | |
| Oncology Day Unit, Frankston Hospital | |
| Frankston, Australia, 3199 | |
| Brazil | |
| Hospital Araujo Jorge - Associacao de Combate ao Cancer em Goias | |
| Goiania, GO, Brazil, 74605-070 | |
| Hospital de Clinicas da Universidade Federal do Parana | |
| Curitiba, PR, Brazil, 80060-900 | |
| Universidade Federal do Rio de Janeiro - Hospital Universitario Clementino Fraga Filho | |
| Rio de Janeiro, RJ, Brazil, 21941-590 | |
| Hospital de Cancer de Barretos - Fundacao Pio XII | |
| Barretos, SP, Brazil, 14784-400 | |
| Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo | |
| Sao Paulo, SP, Brazil, 05403-000 | |
| Canada, Quebec | |
| Sir Mortimer B. Davis - Jewish General Hospital | |
| Montreal, Quebec, Canada, H3T 1E2 | |
Sponsors and Collaborators
Eisai Inc.
Investigators
| Study Director: | Elyane Lombardy, M.D. | Ligand Pharmaceuticals |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00055146 History of Changes |
| Other Study ID Numbers: | L4389-34 |
| Study First Received: | February 19, 2003 |
| Last Updated: | April 16, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Denileukin diftitox Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013