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NCT00211185 · ClinicalTrials.gov registry record · Phase 2

A Study of ONTAK and CHOP in Newly Diagnosed, Peripheral T-Cell Lymphoma

A Phase 2 study of Lymphoma, T-Cell, Peripheral, sponsored by Eisai.

Completed
Registry status
Phase 2
Development phase
49
Enrollment target
20
Study locations

NCT00211185 is a Phase 2 study of Lymphoma, T-Cell, Peripheral that has completed, run by Eisai. The registered enrollment target is 49 participants, below the 324-participant average among 6 other Lymphoma, T-Cell, Peripheral trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT00211185, a Phase 2 study of Lymphoma, T-Cell, Peripheral, has completed, sponsored by Eisai.

COMPLETED
Registry status
Phase 2
Development phase
49 participants
Enrollment target
20
Study locations

Study Summary

Study of ONTAK and CHOP (chemotherapy drugs) to find out their ability to make Peripheral T-cell lymphoma disappear (for any period of time) and potentially lengthen life. The study will also compare what kind of side effects these drugs cause and how often they occur. The hypothesis is that patients with newly diagnosed peripheral T-Cell lymphoma, when given ONTAK + CHOP, will tolerate the treatment and will have a 20% improvement in response rate when compared to CHOP alone.

Conditions Studied

Lymphoma, T-Cell, Peripheral

Interventions

  • DRUG Cyclophosphamide
  • DRUG Doxorubicin
  • DRUG Vincristine
  • DRUG Prednisone
  • DRUG Denileukin diftitox

Study Locations (20)

Illinois

  • Hematology Oncology Associates of IL - Chicago
  • Robert H. Lurie Comprehensive Cancer Center - Chicago
  • Rush University Medical Center - Chicago
  • Cancer Care & Hematology Specialists of Chicagoland - Niles

Missouri

  • Missouri Cancer Associates - Columbia
  • Kansas City Cancer Centers - Kansas City
  • St. Joseph Oncology Inc. - Saint Joseph
  • Arch Medical Services - St Louis

Florida

  • Ocala Oncology Center - Ocala
  • Cancer Centers of Florida, P.A. - Ocoee

Massachusetts

  • Dana Farber/ Harvard Cancer Center - Boston
  • New England Medical Center - Boston

Alabama

  • Birmingham Hematology and Oncology - Birmingham

Arizona

  • Hematology Oncology Associates - Phoenix

California

  • Stanford Cancer Center - Stanford

Colorado

  • Rocky Mountain Cancer Center - Denver

Trial Details

FieldValue
Enrollment Target 49 participants
Start Date 2004-03-14
Est. Completion 2009-12-23
Phase Phase 2

Sponsor

Eisai

287 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00211185

The ClinicalTrials.gov registry entry for NCT00211185 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 324-participant average among 6 other Lymphoma, T-Cell, Peripheral trials with a reported enrollment target (85% 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, Peripheral appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT00211185 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Illinois, Missouri, Florida.

Frequently Asked Questions

What is clinical trial NCT00211185 about?

NCT00211185 is a clinical study titled "A Study of ONTAK and CHOP in Newly Diagnosed, Peripheral T-Cell Lymphoma". Study of ONTAK and CHOP (chemotherapy drugs) to find out their ability to make Peripheral T-cell lymphoma disappear (for any period of time) and potentially lengthen life. The study will also compare what kind of side effects these drugs cause and how often they occur. The hypothesis is that patient...

What is the current status of trial NCT00211185?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2004-03-14. Estimated completion is 2009-12-23.

What conditions does trial NCT00211185 study?

This clinical trial studies the following conditions: Lymphoma, T-Cell, Peripheral.

What interventions are being tested in trial NCT00211185?

The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG), Vincristine (DRUG), Prednisone (DRUG), Denileukin diftitox (DRUG).

Who is sponsoring clinical trial NCT00211185?

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

Where is trial NCT00211185 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. 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.