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NCT01698905 · ClinicalTrials.gov registry record · Phase 2
Treatment-free Remission After Achieving Sustained MR4.5 on Nilotinib (ENESTop)
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 163
- Enrollment target
NCT01698905: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT01698905 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 163 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01698905, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 163 participants
- Enrollment target
Study Summary
A clinical research study to find out if it is safe to stop the drug nilotinib (Tasigna) in chronic myeloid leukemia (CML) patients. Patients who started treatment with imatinib (Gleevec) when they were first diagnosed with CML, then switched to nilotinib (Tasigna) for at least 2 years with the combined time on imatinib (Gleevec) and nilotinib (Tasigna) for at least 3 years and have very small amount of leukemia cells remaining after the nilotinib (Tasigna) treatment will qualify for the study.
Primary Outcome
TFR is defined as no confirmed loss of MR4 (Molecular response 4.0 log reduction from baseline) or loss of MMR (major molecular response) and no re-starting of nilotinib therapy within 12 months following cessation of nilotinib. Confirmed loss of MR4 is two consecutive BCR-ABL \> 0.01% IS. Loss of MMR does not require confirmation.
Interventions
- DRUG nilotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 163 participants |
| Start Date | 2012-12-20 |
| Est. Completion | 2025-01-29 |
| Phase | Phase 2 |
What the finished NCT01698905 record still lists
NCT01698905 is an interventional study that assigns participants to a tested intervention. The registered 163 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 (23% higher).
The record links to 0 conditions, and to 1 intervention - of which nilotinib is the first listed.
NCT01698905 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01698905 about?
NCT01698905 is a clinical study titled "Treatment-free Remission After Achieving Sustained MR4.5 on Nilotinib (ENESTop)". A clinical research study to find out if it is safe to stop the drug nilotinib (Tasigna) in chronic myeloid leukemia (CML) patients. Patients who started treatment with imatinib (Gleevec) when they were first diagnosed with CML, then switched to nilotinib (Tasigna) for at least 2 years with the comb...
What is the current status of trial NCT01698905?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 163 participants. The study started on 2012-12-20. Estimated completion is 2025-01-29.
What interventions are being tested in trial NCT01698905?
The interventions under investigation include: nilotinib (DRUG).
Who is sponsoring clinical trial NCT01698905?
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 NCT01698905's enrollment target sits among peer trials
163 418th of 2000 higher than 1,583 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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