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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 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.

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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.

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

FieldValue
Enrollment Target 60 participants
Start Date 2001-05
Est. Completion 2006-01
Phase Phase 4

Sponsor

Eisai

287 total trials

What the Registry Record Tells You About NCT00211198

The ClinicalTrials.gov registry entry for NCT00211198 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 206-participant average among 4 other Lymphoma, T-Cell, Cutaneous trials with a reported enrollment target (71% lower). The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.

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 reports 9 study locations spanning 8 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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