Study of ONTAK® to Treat Cutaneous T-Cell Lymphoma (CTCL)
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ClinicalTrials.gov Identifier: NCT00211198 |
Recruitment Status
:
Completed
First Posted
: September 21, 2005
Last Update Posted
: March 5, 2008
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Sponsor:
Eisai Inc.
Collaborators:
Tufts Medical Center
National Cancer Institute (NCI)
Ligand Pharmaceuticals
Information provided by:
Eisai Inc.
Tracking Information | ||||
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First Submitted Date ICMJE | September 13, 2005 | |||
First Posted Date ICMJE | September 21, 2005 | |||
Last Update Posted Date | March 5, 2008 | |||
Study Start Date ICMJE | May 2001 | |||
Actual Primary Completion Date | January 2005 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
To estimate response rates (CR + CCR + PR) according to CD25 status (CD25 positive and negative) after 4 cycles of ONTAK. | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT00211198 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Study of ONTAK® to Treat Cutaneous T-Cell Lymphoma (CTCL) | |||
Official Title ICMJE | Open Label Study of ONTAK® (Denileukin Diftitox, DAB389IL-2) to Estimate Response in Cutaneous T-Cell Lymphoma (CTCL) According to CD25 Status | |||
Brief Summary | The purpose of this research study is to evaluate how effective ONTAK is in the treatment of cutaneous T-cell Lymphoma (CTCL) and determine whether the presence of a type of protein called CD25 on the cancer cells makes a difference in how the body responds to the treatment. The hypothesis is that there is no difference in response rate for patients whose tumor cells are CD25 positive or negative. |
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 4 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Lymphoma, T-Cell, Cutaneous | |||
Intervention ICMJE | Drug: ONTAK (denileukin difitox, DAB389IL-2) | |||
Study Arms | Not Provided | |||
Publications * | Francine Foss, Madeleine Duvic, Larisa Geskin, Joseph Anderson, Pierluigi Porcu, Raymond J. Hohl, Maureen Cooper, Jasmine M. Zain, John Zic, Patrica Hibberd, and Mark Acosta Efficacy and Safety of Denileukin Diftitox (Ontak®) in the Treatment of Cutaneous T-Cell Lymphoma (CTCL) According to CD25 Status. Blood (ASH Annual Meeting Abstracts), Nov 2006; 108: 2712. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE |
60 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | January 2006 | |||
Actual Primary Completion Date | January 2005 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00211198 | |||
Other Study ID Numbers ICMJE | #33 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Eisai Inc. | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Eisai Inc. | |||
Verification Date | February 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |