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NCT01227577 · ClinicalTrials.gov registry record · Phase 4
CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib
A Phase 4 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 128
- Enrollment target
NCT01227577: Completed Phase 4 study, sponsored by Novartis Pharmaceuticals.
NCT01227577 is a Phase 4 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 128 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01227577, a Phase 4 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 128 participants
- Enrollment target
Study Summary
"This is a single-arm, open-label, multi-center study of complete molecular response (CMR) in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP). The study is designed to evaluate early and deep molecular responses up to 4 years on nilotinib treatment. The primary end point is Rate of confirmed CMR in newly diagnosed Philadelphia chromosome positive CML-CP patients."
Primary Outcome
CMR was defined as at least 4.5 log reduction of breakpoint cluster region gene/Abelson proto-oncogene (Bcr-Abl) transcipts from the standardized baseline on the international scale (equivalent to Bcr-Abl \<=0.0032% IS) with a minimum of 25,614 ABL control copies. CMR was to be confirmed by a second polymerase chain reaction (PCR) sample drawn 3 months later where the results should be less than or equal to 0.0032% with a minimum of 25,614 Abelson proto-oncogene (ABL) control copies.
Interventions
- DRUG Nilotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2010-11 |
| Est. Completion | 2014-11 |
| Phase | Phase 4 |
What the finished NCT01227577 record still lists
NCT01227577 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which Nilotinib is the first listed.
NCT01227577 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01227577 about?
NCT01227577 is a clinical study titled "CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib". "This is a single-arm, open-label, multi-center study of complete molecular response (CMR) in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP). The study is designed to evaluate early and deep molecular responses up to ...
What is the current status of trial NCT01227577?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 128 participants. The study started on 2010-11. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01227577?
The interventions under investigation include: Nilotinib (DRUG).
Who is sponsoring clinical trial NCT01227577?
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 NCT01227577's enrollment target sits among peer trials
128 634th of 2000 higher than 1,362 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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