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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: Completed Phase 2 study of Lymphoma, T-Cell, Peripheral, sponsored by Eisai.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An adverse event (AE) was any medical occurrence in a participant who was administered denileukin diftitox and cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP), and did not necessarily have a causal relationship with this treatment. An AE included any side effect, injury, toxicity, sensitivity reaction, or any undesirable clinical or laboratory event that was not normally observed in the participant. Safety was assessed for all participants who received at least one dose of stud
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2004-03-14 |
| Est. Completion | 2009-12-23 |
| Phase | Phase 2 |
What the finished NCT00211185 record still lists
NCT00211185 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 324-participant average among 6 other Lymphoma, T-Cell, Peripheral trials with a reported enrollment target (85% lower).
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 names 20 study sites across 12 states, led by 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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