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NCT00211198 · ClinicalTrials.gov registry record · Phase 4
Study of ONTAK® to Treat Cutaneous T-Cell Lymphoma (CTCL)
A Phase 4 study of Lymphoma, T-Cell, Cutaneous, sponsored by Eisai.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
- 9
- Study locations
NCT00211198: Completed Phase 4 study of Lymphoma, T-Cell, Cutaneous, sponsored by Eisai.
NCT00211198 is a Phase 4 study of Lymphoma, T-Cell, Cutaneous that has completed, run by Eisai. The registered enrollment target is 60 participants, below the 206-participant average among 4 other Lymphoma, T-Cell, Cutaneous trials with a reported enrollment target (71% lower). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00211198, a Phase 4 study of Lymphoma, T-Cell, Cutaneous, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
- 9
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG ONTAK (denileukin difitox, DAB389IL-2)
Study Locations (9)
Ohio
- University Hospitals of Cleveland - Cleveland
- Ohio State University - Columbus
California
- City of Hope National Medical Center - Duarte
Connecticut
- Yale University School of Medicine - New Haven
Iowa
- The University of Iowa - Iowa City
Massachusetts
- New England Medical Center - Boston
Pennsylvania
- University of Pittsburgh - Pittsburgh
Tennessee
- Vanderbilt University - Nashville
Texas
- The University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2001-05 |
| Est. Completion | 2006-01 |
| Phase | Phase 4 |
What the finished NCT00211198 record still lists
NCT00211198 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 206-participant average among 4 other Lymphoma, T-Cell, Cutaneous trials with a reported enrollment target (71% lower).
The record links to 1 condition, with Lymphoma, T-Cell, Cutaneous appearing as the primary indexed condition, and to 1 intervention - of which ONTAK (denileukin difitox, DAB389IL-2) is the first listed.
NCT00211198 lists 9 locations in 8 states (Ohio, California, Connecticut).
Frequently Asked Questions
What is clinical trial NCT00211198 about?
NCT00211198 is a clinical study titled "Study of ONTAK® to Treat Cutaneous T-Cell Lymphoma (CTCL)". 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 ...
What is the current status of trial NCT00211198?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2001-05. Estimated completion is 2006-01.
What conditions does trial NCT00211198 study?
This clinical trial studies the following conditions: Lymphoma, T-Cell, Cutaneous.
What interventions are being tested in trial NCT00211198?
The interventions under investigation include: ONTAK (denileukin difitox, DAB389IL-2) (DRUG).
Who is sponsoring clinical trial NCT00211198?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00211198 being conducted?
This trial has 9 study locations across California, Connecticut, Iowa, Massachusetts, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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