Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 2

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

NCT00211185 · View on ClinicalTrials.gov ↗

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.

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

71 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 71 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00211185 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Illinois, Missouri, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00211185?

The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG), Vincristine (DRUG), Prednisone (DRUG), Denileukin diftitox (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00211185?

This trial is sponsored by Eisai, which has 71 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial