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NCT00171223 · ClinicalTrials.gov registry record · Phase 2
An Extension Study to Determine the Efficacy and Safety of STI571 in Participants With Chronic Myeloid Leukemia Who Are Refractory to or Intolerant of Interferon-Alpha
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 532
- Enrollment target
NCT00171223: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT00171223 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 532 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (300% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00171223, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 532 participants
- Enrollment target
Study Summary
During the Core Phase of the study, participants received STI571 at a dose of 400 milligrams (mg) daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study provided that, in the opinion of the investigator, they had benefited from treatment with STI571 and there were no safety concerns.
Primary Outcome
Response was evaluated from bone marrow aspirates and biopsy samples. Bone marrow cytogenetic studies were performed every 3 months during the core phase of the study, then twice yearly, then annually to evaluate Philadelphia chromosome positive (Ph+). Cytogenetic response was defined as the best response the participant achieved during study. Based on the percentage of Ph+ cells = (positive cells/ examined cells) x100, at each BM assessment the cytogenetic response was classified as: Complete C
Interventions
- DRUG STI571
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 532 participants |
| Start Date | 1999-12-06 |
| Est. Completion | 2013-11-29 |
| Phase | Phase 2 |
What the finished NCT00171223 record still lists
NCT00171223 is an interventional study that assigns participants to a tested intervention. The registered 532 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (300% higher).
The record links to 0 conditions, and to 1 intervention - of which STI571 is the first listed.
NCT00171223 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00171223 about?
NCT00171223 is a clinical study titled "An Extension Study to Determine the Efficacy and Safety of STI571 in Participants With Chronic Myeloid Leukemia Who Are Refractory to or Intolerant of Interferon-Alpha". During the Core Phase of the study, participants received STI571 at a dose of 400 milligrams (mg) daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study provided that, in the opinion of the investigator, they ha...
What is the current status of trial NCT00171223?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 532 participants. The study started on 1999-12-06. Estimated completion is 2013-11-29.
What interventions are being tested in trial NCT00171223?
The interventions under investigation include: STI571 (DRUG).
Who is sponsoring clinical trial NCT00171223?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00171223's enrollment target sits among peer trials
532 64th of 2000 higher than 1,937 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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