Treatment-free Remission After Achieving Sustained MR4.5 on Nilotinib (ENESTop) (ENESTop)
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ClinicalTrials.gov Identifier: NCT01698905 |
Recruitment Status :
Active, not recruiting
First Posted : October 3, 2012
Results First Posted : January 13, 2021
Last Update Posted : March 21, 2022
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Chronic Myeloid Leukemia |
Intervention |
Drug: nilotinib |
Enrollment | 163 |
Participant Flow
Recruitment Details | A total of 163 patients were enrolled into this study. 126 of the 163 patients who completed 52 weeks of nilotinib treatment in the NTCS phase entered the TFR phase and were part of the Full analysis Set (FAS). |
Pre-assignment Details | Approximately 117 patients were planned to be enrolled into this study. |
Arm/Group Title | NTCS Phase |
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Patients with minimum 3 years of tyrosine kinase inhibitor treatment (first with imatinib and then switched to nilotinib) since initial diagnosis, at least 2 years of nilotinib treatment prior to study entry and who achieved MR4.5 (local laboratory assessment) during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening |
Period Title: Overall Study | |
Started | 163 |
Still on Study Phase | 0 |
TFR Phase | 126 |
NTRI Phase | 51 |
NTCT Phase | 26 |
TFR-2 Phase | 2 |
NTRI-2 Phase | 1 |
NTCT-P Phase Phase | 6 |
Completed [1] | 152 |
Not Completed | 11 |
Reason Not Completed | |
Adverse Event | 4 |
Physician Decision | 2 |
Pregnancy | 1 |
Protocol Violation | 1 |
Subject/guardian decision | 2 |
Death | 1 |
[1]
Completed = Completed 52 weeks of NTCS phase
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Baseline Characteristics
Arm/Group Title | NTCS Phase | |
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Patients with minimum 3 years of tyrosine kinase inhibitor treatment (first with imatinib and then switched to nilotinib) since initial diagnosis, at least 2 years of nilotinib treatment prior to study entry and who achieved MR4.5 (local laboratory assessment) during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening | |
Overall Number of Baseline Participants | 163 | |
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Safety Set: The safety set included all patients who received at least one dose of study medication in the Consolidation Phase.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 163 participants | |
54.3 (13.99) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 163 participants | |
Female |
86 52.8%
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Male |
77 47.2%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 163 participants |
Caucasian | 127 | |
Black | 6 | |
Asian | 23 | |
Native American | 1 | |
Other | 6 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Principal Investigators are NOT employed by the organization sponsoring the study. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial.
Results Point of Contact
Name/Title: | Study Director |
Organization: | Novartis |
Phone: | 862-778-8300 |
EMail: | novartis.email@novartis.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
ClinicalTrials.gov Identifier: | NCT01698905 |
Other Study ID Numbers: |
CAMN107A2408 2012-003186-18 ( EudraCT Number ) |
First Submitted: | October 1, 2012 |
First Posted: | October 3, 2012 |
Results First Submitted: | December 17, 2020 |
Results First Posted: | January 13, 2021 |
Last Update Posted: | March 21, 2022 |