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NCT00980018 · ClinicalTrials.gov registry record · Phase 4
An Exploratory Trial to Assess the Improvement of Adverse Events in Chronic Myelogenous Leukemia Patients Treated With Imatinib When Switched to Nilotinib Treatment
A Phase 4 study of Chronic Myelogenous Leukemia, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 52
- Enrollment target
- 20
- Study locations
NCT00980018: Completed Phase 4 study of Chronic Myelogenous Leukemia, sponsored by Novartis Pharmaceuticals.
NCT00980018 is a Phase 4 study of Chronic Myelogenous Leukemia that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 52 participants, below the 281-participant average among 29 other Chronic Myelogenous Leukemia trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00980018, a Phase 4 study of Chronic Myelogenous Leukemia, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 52 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this exploratory study will be to examine changes in chronic low grade chronic adverse events, measured by Common Terminology Criteria for Adverse Events (CTCAE) grading, when patients are switched from imatinib to nilotinib therapy.
Primary Outcome
A patient was considered improved if 50% or more of the chronic imatinib-related chronic low grade nonhematologic AEs showed improvement (a decrease in CTCAE \[Common Terminology Criteria for Adverse Events\] grade or complete resolution).
Conditions Studied
Interventions
- DRUG Nilotinib
Study Locations (20)
Texas
- Texas Oncology, P.A. - Bedford
- Presbyterian Hospital of Dallas TexasOncology@PresbyterianHosp - Dallas
- Texas Oncology Texas Oncology - Sugar Land - Dallas
- MD Anderson Cancer Center/University of Texas - Houston
- Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2) - San Antonio
Arkansas
- Highlands Oncology Group - Fayetteville
- Hematology Oncology Services of Arkansas SC - Little Rock
California
- USC Norris Cancer Center LAC & USC Medical Center - Los Angeles
- Southwest Cancer Care Murrieta - Poway
Florida
- Florida Cancer Institute - New Port Richey
- Cancer Centers of Florida PA Cancer Centers of FL-Orlando-4 - Ocoee
Oregon
- Northwest Cancer Specialists Salmon Creek Office - Portland
- Oregon Health Sciences University - Portland
Colorado
- Rocky Mountain Cancer Centers RMCC - Aurora - Greenwood Village
Illinois
- Stroger Cook County Hospital John H. Stroger Hospital - Chicago
Indiana
- St. Francis Hospital and Health Centers IndianaBlood&MarrowTransplantn - Beech Grove
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2009-12 |
| Est. Completion | 2012-12 |
| Phase | Phase 4 |
What the finished NCT00980018 record still lists
NCT00980018 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 281-participant average among 29 other Chronic Myelogenous Leukemia trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Chronic Myelogenous Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Nilotinib is the first listed.
NCT00980018 names 20 study sites across 12 states, led by Texas, Arkansas, California.
Frequently Asked Questions
What is clinical trial NCT00980018 about?
NCT00980018 is a clinical study titled "An Exploratory Trial to Assess the Improvement of Adverse Events in Chronic Myelogenous Leukemia Patients Treated With Imatinib When Switched to Nilotinib Treatment". The purpose of this exploratory study will be to examine changes in chronic low grade chronic adverse events, measured by Common Terminology Criteria for Adverse Events (CTCAE) grading, when patients are switched from imatinib to nilotinib therapy.
What is the current status of trial NCT00980018?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 52 participants. The study started on 2009-12. Estimated completion is 2012-12.
What conditions does trial NCT00980018 study?
This clinical trial studies the following conditions: Chronic Myelogenous Leukemia.
What interventions are being tested in trial NCT00980018?
The interventions under investigation include: Nilotinib (DRUG).
Who is sponsoring clinical trial NCT00980018?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00980018 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Myelogenous Leukemia
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Where NCT00980018's enrollment target sits among peer trials
52 16th of 29 higher than 13 of 29 other Chronic Myelogenous Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Myelogenous Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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