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NCT00050999 · ClinicalTrials.gov registry record · Phase 4

Study of ONTAK (Denileukin Diftitox) in Cutaneous T-Cell Lymphoma (CTCL) Patients

A Phase 4 study of Mycosis Fungoides and Sezary Syndrome, sponsored by Eisai.

Completed
Registry status
Phase 4
Development phase
195
Enrollment target
20
Study locations

NCT00050999 is a Phase 4 study of Mycosis Fungoides and Sezary Syndrome that has completed, run by Eisai. The registered enrollment target is 195 participants, above the 153-participant average among 19 other Mycosis Fungoides trials with a reported enrollment target (27% higher). The trial reports 20 study locations across 7 states.

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The verdict

NCT00050999, a Phase 4 study of Mycosis Fungoides and Sezary Syndrome, has completed, sponsored by Eisai.

COMPLETED
Registry status
Phase 4
Development phase
195 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to compare the effectiveness of two dose levels of ONTAK (denileukin diftitox) in treating patients who have recurrent or persistent cutaneous T-cell lymphoma.

Conditions Studied

Mycosis Fungoides Sezary Syndrome Lymphoma, T-Cell, Cutaneous

Interventions

  • DRUG ONTAK

Study Locations (20)

Other

  • LKH Universitatsklinikum Graz - Graz
  • Allgemeines Krankenhaus der Stadt Wien - Vienna
  • Universitatsklinikum Charite - Berlin
  • University of Erlangen - Erlangen
  • Universitatsklinikum Essen - Essen
  • J.W. Goethe University Frankfurt - Frankfurt
  • Universitatskrankenhaus Eppendorf - Hamburg
  • Universitatsklinikum Mannheim - Mannheim
  • Universitatsklinikum Munster - Münster
  • Sektion Dermatologische Onkologie - Tübingen
  • LUMC, Department of Dermatology - Leiden
  • Medical Academy in Gdansk, Dept. of Hematology - Gdansk

New South Wales

  • Level 4 Department of Haematology Royal North Shore Hospital - Saint Leonard's
  • Westmead Hospital, Department of Haematology - Westmead

Queensland

  • Mater Misericordiae Adult Hospital - South Brisbane
  • Oncology Haematology Radiation Oncology Unit, Princess Alexandra Hospital - Woolloongabba

Texas

  • University of Texas, M.D. Anderson Cancer Center - Houston

Alberta

  • Cross Cancer Centre - Edmonton

Ontario

  • Hamilton Regional Cancer Center - Hamilton

Quebec

  • Jewish General Hospital - Montreal

Trial Details

FieldValue
Enrollment Target 195 participants
Start Date 1995-06
Est. Completion 2006-12
Phase Phase 4

Sponsor

Eisai

287 total trials

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What the Registry Record Tells You About NCT00050999

The ClinicalTrials.gov registry entry for NCT00050999 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 195 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 153-participant average among 19 other Mycosis Fungoides trials with a reported enrollment target (27% higher). The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Mycosis Fungoides appearing as the primary indexed condition, and to 1 intervention - of which ONTAK is the first listed.

NCT00050999 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Other, New South Wales, Queensland.

Frequently Asked Questions

What is clinical trial NCT00050999 about?

NCT00050999 is a clinical study titled "Study of ONTAK (Denileukin Diftitox) in Cutaneous T-Cell Lymphoma (CTCL) Patients". The purpose of this study is to compare the effectiveness of two dose levels of ONTAK (denileukin diftitox) in treating patients who have recurrent or persistent cutaneous T-cell lymphoma.

What is the current status of trial NCT00050999?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 195 participants. The study started on 1995-06. Estimated completion is 2006-12.

What conditions does trial NCT00050999 study?

This clinical trial studies the following conditions: Mycosis Fungoides, Sezary Syndrome, Lymphoma, T-Cell, Cutaneous.

What interventions are being tested in trial NCT00050999?

The interventions under investigation include: ONTAK (DRUG).

Who is sponsoring clinical trial NCT00050999?

This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00050999 being conducted?

This trial has 20 study locations across Texas, New South Wales, Queensland, Alberta, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.