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Completed Phase 4 Interventional

Study of ONTAK® to Treat Cutaneous T-Cell Lymphoma (CTCL)

ClinicalTrials.gov ID: NCT00211198

Public ClinicalTrials.gov record NCT00211198. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 3:23 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Open Label Study of ONTAK® (Denileukin Diftitox, DAB389IL-2) to Estimate Response in Cutaneous T-Cell Lymphoma (CTCL) According to CD25 Status

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00211198
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Eisai Inc.
Industry
Enrollment
60 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 2001 (Type not available)
Primary completion
Jan 2005 (Actual)
Completion
Jan 2006 (Actual)
Last update posted
Mar 5, 2008

2001 – 2006

United States locations

U.S. sites
9
U.S. states
8
U.S. cities
9
Facility City State ZIP Site status
City of Hope National Medical Center Duarte California 91010 —
Yale University School of Medicine New Haven Connecticut 06520 —
The University of Iowa Iowa City Iowa 52242 —
New England Medical Center Boston Massachusetts — —
University Hospitals of Cleveland Cleveland Ohio 44106 —
Ohio State University Columbus Ohio 43210 —
University of Pittsburgh Pittsburgh Pennsylvania 15213 —
Vanderbilt University Nashville Tennessee 37232 —
The University of Texas MD Anderson Cancer Center Houston Texas 77030-4009 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00211198, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 5, 2008 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00211198 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →