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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01254188
Registration number
NCT01254188
Ethics application status
Date submitted
2/12/2010
Date registered
6/12/2010
Date last updated
3/03/2016
Titles & IDs
Public title
Safety and Efficacy of Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia Patients
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Scientific title
Extending Molecular Responses With Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) Patients in Chronic Phase
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Secondary ID [1]
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CAMN107E2401
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Universal Trial Number (UTN)
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Trial acronym
ENESTxtnd
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Myeloid Leukemia
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Condition category
Condition code
Cancer
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0
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Leukaemia - Acute leukaemia
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Cancer
0
0
0
0
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Leukaemia - Chronic leukaemia
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Cancer
0
0
0
0
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Nilotinib
Experimental: Nilotinib - 300 mg BID
Treatment: Drugs: Nilotinib
This was an open-label, single-arm, prospective, multi-center, Phase IIIb clinical study with nilotinib 300 mg bid treatment in newly diagnosed CML-CP patients not previously treated with imatinib therapy and diagnosed within 6 months of study entry. For patients insufficiently responding to nilotinib 300 mg bid, the dose may have been increased to 400 mg bid. Among patients with adverse events who had dose reduction, this study also allowed a possible re-escalation to 300 mg bid.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The Percentage of Patients Achieving MMR by 12 Months
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Assessment method [1]
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MMR is defined as BCR-ABL ratio (%) on IS \<= 0.1% (corresponds to \>=3 log reduction of BCR-ABL transcripts from standardized baseline value). Clopper-Pearson method
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Timepoint [1]
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12 months
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Secondary outcome [1]
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Time to Molecular Response at 24 Months
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Assessment method [1]
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Estimated median time to first MMR by Kaplan-Meier method
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Timepoint [1]
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24 months
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Secondary outcome [2]
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Duration of Major Molecular Response
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Assessment method [2]
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Kaplan-Meier estimates of duration of first MMR among patients who achieved MMR (FAS) Duration of first MMR (months) = (Minimum date of (loss of first MMR , CML-related death, progression to AP/BC during study treatment, censoring) - date of first MMR + 1) / 30.4375
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Timepoint [2]
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3, 6, 9, 12, 15, 18, 21, 24 Months after MMR was detected
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Secondary outcome [3]
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Complete Cytogenetic Response
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Assessment method [3]
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Complete cytogenetic response (CCyR) is defined as a value of 0% Ph+ metaphases in bone marrow.
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Timepoint [3]
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6 months
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Secondary outcome [4]
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Percentage of Participants Estimated to Maintain Their First CCyR for 6, 12, 18, and 24 Months After the First CCyR Was Achieved as Determined by Kaplan Meier Estimatation.
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Assessment method [4]
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\* CCyR = 0% Ph+ metaphases based on at least 20 metaphases from bone marrow cytogenetics.
Duration of first CCyR (months) = (date of CCyR loss or censoring - date of first CCyR +1) / 30.4375
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Timepoint [4]
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6,12,18 and 24 months
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Secondary outcome [5]
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Overall Survival
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Assessment method [5]
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OS was defined as the time between date of study entry and date of death due to any cause at any time during the study, including the follow-up period after discontinuation of treatment.
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Timepoint [5]
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3, 6, 9, 12, 15, 18, 21, 24 Months
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Secondary outcome [6]
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Kaplan-Meier Estimates of Progression-free Survival
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Assessment method [6]
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PFS was defined as the time from the date of study entry to the date of event defined as the first documented disease progression to AP/BC or the date of death from any cause occurring on treatment.
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Timepoint [6]
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3,6,9,12,15,18,21,and 24 months
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Secondary outcome [7]
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Kaplan-Meier Estimates of Failure-free Survival
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Assessment method [7]
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Time to event (months) = (date of event or censoring - date of study entry + 1) / 30.4375. Date of event is the earliest date of the following events during treatment : discontinuation of nilotinib for nilotinib-related adverse events, death due to any cause, progression to AP or BC, loss of PCyR, loss of CCyR, loss of CHR. Time is censored at the date of last assessment in the trial for patients without event.
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Timepoint [7]
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3,6,9,12,15,18,21,and 24 months
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Eligibility
Key inclusion criteria
-Patients with chronic myeloid leukemia in the chronic phase diagnosed within 6 months of study entry
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Treatment with tyrosine kinase inhibitor or other antileukemic agents or treatments (including HSCT) for longer than 2 weeks, with exception of hydroxyurea and/or anagrelide
* Uncontrolled congestive heart failure or hypertension
* Myocardial infarction or unstable angina pectoris within past 12 months
* Known T315I mutations
* QTcF >450 msec
* Significant arrhythmias
Other protocol-defined inclusion/exclusion criteria may apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2014
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Sample size
Target
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Accrual to date
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Final
421
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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Novartis Investigative Site - Canberra
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Novartis Investigative Site - Concord NSW
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Novartis Investigative Site - Gosford
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Novartis Investigative Site - Perth
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Recruitment postcode(s) [1]
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2605 - Canberra
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Recruitment postcode(s) [2]
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2139 - Concord NSW
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Recruitment postcode(s) [3]
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2250 - Gosford
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2747 - Kingswood
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Recruitment postcode(s) [5]
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2217 - Kogarah
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2170 - Liverpool
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Recruitment postcode(s) [7]
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2065 - St. Leonards
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2145 - Westmead
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Recruitment postcode(s) [9]
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4810 - Douglas
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4102 - Woolloongabba
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Recruitment postcode(s) [11]
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5000 - Adelaide
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5042 - Bedford Park
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7000 - Hobart
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3128 - Box Hill
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3168 - Clayton
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3065 - Fitzroy
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3084 - Heidelberg
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3050 - Parkville
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3690 - Wodonga
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6009 - Nedlands
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6000 - Perth
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Recruitment outside Australia
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Algeria
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Bouzareah
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Algeria
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Oran
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BA
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Brazil
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GO
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United Arab Emirates
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Dubai
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will further investigate the safety and efficacy of nilotinib in newly diagnosed chronic myeloid leukemia patients in the chronic phase
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Trial website
https://clinicaltrials.gov/study/NCT01254188
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Trial related presentations / publications
Hughes TP, Munhoz E, Aurelio Salvino M, Ong TC, Elhaddad A, Shortt J, Quach H, Pavlovsky C, Louw VJ, Shih LY, Turkina AG, Meillon L, Jin Y, Acharya S, Dalal D, Lipton JH. Nilotinib dose-optimization in newly diagnosed chronic myeloid leukaemia in chronic phase: final results from ENESTxtnd. Br J Haematol. 2017 Oct;179(2):219-228. doi: 10.1111/bjh.14829. Epub 2017 Jul 12.
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01254188
Download to PDF