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NCT01744665 · ClinicalTrials.gov registry record · Phase 2

A Study That Switched Patients From Imatinib to Nilotinib and Then Was Followed by Treatment Cessation

A Phase 2 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
59
Enrollment target

NCT01744665: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.

NCT01744665 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 59 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01744665, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
59 participants
Enrollment target

Study Summary

To evaluate molecular relapse free rates 6 months after stopping nilotinib therapy in patients who achieve MR4.5

Primary Outcome

Percentage of particpants without confirmed loss of MMR within 6 months following nilotinib TFR is calculated by dividing the number of patients with no documented confirmed loss of MR4, in the first 6 months after starting nilotinib TFR phase by the number of patients who entered nilotinib TFR phase. Molecular relapse is defined as having a confirmed BCR-ABL ratio above MMR (2 consecutive BCR-ABL levels \>0.1% IS taken approximately 4 weeks apart).

Interventions

  • DRUG nilotinib

Trial Details

FieldValue
Enrollment Target 59 participants
Start Date 2013-08-12
Est. Completion 2018-09-29
Phase Phase 2
Novartis Pharmaceuticals

1,375 total trials

What the finished NCT01744665 record still lists

NCT01744665 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).

The record links to 0 conditions, and to 1 intervention - of which nilotinib is the first listed.

NCT01744665 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01744665 about?

NCT01744665 is a clinical study titled "A Study That Switched Patients From Imatinib to Nilotinib and Then Was Followed by Treatment Cessation". To evaluate molecular relapse free rates 6 months after stopping nilotinib therapy in patients who achieve MR4.5

What is the current status of trial NCT01744665?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2013-08-12. Estimated completion is 2018-09-29.

What interventions are being tested in trial NCT01744665?

The interventions under investigation include: nilotinib (DRUG).

Who is sponsoring clinical trial NCT01744665?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01744665's enrollment target sits among peer trials

59 1133rd of 2000 higher than 866 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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Source: ClinicalTrials.gov NCT01744665, the US trial registry maintained by the National Library of Medicine. NCT01744665 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.