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Sponsored by: |
Eisai Inc. |
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Information provided by: | Eisai Inc. |
ClinicalTrials.gov Identifier: | NCT00211276 |
The goal of this clinical research study is to find out if the study drug, ONTAK (denileukin diftitox), can shrink or slow the growth of B-cell non-Hodgkin's lymphoma (NHL) in patients whose disease has not responded to prior treatments, or has relapsed after an initial response to prior treatments. The safety of treatment with ONTAK will also be studied. The hypothesis is that patients with relapsed or refractory B-cell NHL and mild to moderate myelosuppression treated with ONTAK at a new dosing regimen will respond sufficiently to warrant further study.
Condition | Intervention | Phase |
---|---|---|
Lymphoma, B-Cell |
Drug: ONTAK (denileukin diftitox) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II Multicenter Study of ONTAK in Patients With Relapsed or Refractory, B-Cell Non-Hodgkins Lymphoma. |
Estimated Enrollment: | 50 |
Study Start Date: | March 2005 |
Study Completion Date: | February 2007 |
Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
University of California, Los Angeles | |
Los Angeles, California, United States, 90095 | |
Pacific Coast Hematology/Oncology | |
Fountain Valley, California, United States, 92708 | |
Tower Cancer Research Foundation | |
Beverly Hills, California, United States, 90211-1850 | |
United States, Georgia | |
Emory University | |
Atlanta, Georgia, United States, 30306 | |
United States, Illinois | |
Rush University Medical Center | |
Chicago, Illinois, United States, 60612 | |
United States, Iowa | |
Siouxland Hematology-Oncology | |
Sioux City, Iowa, United States, 51101-1733 | |
United States, Missouri | |
Washington University Siteman Cancer Center | |
St. Louis, Missouri, United States, 63110 | |
United States, New Jersey | |
Hackensack University Medical Center | |
Hackensack, New Jersey, United States, 07601 | |
United States, New York | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263 | |
St. Vincent's Comprehensive Cancer Center | |
New York, New York, United States, 10011 | |
United States, Ohio | |
Case Comprehensive Cancer Center | |
Cleveland, Ohio, United States, 44106 | |
United States, Pennsylvania | |
The Western Pennsylvania Hospital | |
Pittsburgh, Pennsylvania, United States, 15224 |
Principal Investigator: | Myron Czuczman, MD | Roswell Park Cancer Institute |
Study ID Numbers: | #123 |
Study First Received: | September 13, 2005 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00211276 History of Changes |
Health Authority: | United States: Institutional Review Board |
Lymphoma, Small Cleaved-cell, Diffuse Lymphoma, B-Cell Lymphatic Diseases Immunoproliferative Disorders B-cell Lymphomas |
Denileukin diftitox Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Antineoplastic Agents Pharmacologic Actions Lymphoma, B-Cell Lymphatic Diseases |
Neoplasms Denileukin diftitox Therapeutic Uses Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |