Clinical Trial Results:
A phase 3 randomised non-inferiority trial to evaluate the use of imatinib, nilotinib and ponatinib in patients with newly-diagnosed chronic phase chronic myeloid leukaemia
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Summary
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EudraCT number |
2012-005696-14 |
Trial protocol |
GB |
Global end of trial date |
16 Sep 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
18 Dec 2019
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First version publication date |
18 Dec 2019
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Other versions |
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Summary report(s) |
File Note - Study Withdrawn |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
6451
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
The Newcastle upon Tyne Hospitals NHS Foundation Trust
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Sponsor organisation address |
Level 1, Regent Point, Regent Farm Road, Newcastle upon Tyne, United Kingdom, NE3 3HD
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Public contact |
Professor Stephen O'Brien, Newcastle University, 0044 0191 282 0904, stephen.o'brien@ncl.ac.uk
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Scientific contact |
Professor Stephen O'Brien, Newcastle University, 0044 0191 282 0904, stephen.o'brien@ncl.ac.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
16 Sep 2016
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
16 Sep 2016
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
The study aims to see if treatment with imatinib is as good as treatment with nilotinib when patients in either group who are not doing so well switch to ponatinib. The response to treatment is measured in the blood and tests will look for leukaemic cells.
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Protection of trial subjects |
This study was terminated prior to the recruitment of any participants, therefore no results are available. As a result, where '9999999' is entered this means the data point is N/A.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Sep 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 9999999
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Worldwide total number of subjects |
9999999
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EEA total number of subjects |
9999999
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
9999999
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||
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Pre-assignment
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Screening details |
The protocol stated that patients would be screened for eligibility to take part in the trial. Screening assessments included: Demography, CML diagnosis, medical history, concomitant medication, haematology, biochemistry, blood glucose, physical examination and Blood Pressure measurement. | |||||||||
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Pre-assignment period milestones
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Number of subjects started |
9999999 | |||||||||
Number of subjects completed |
9999999 | |||||||||
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Period 1
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Period 1 title |
Treatment (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Imatinib | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
imatinib
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
400mg daily (taken OD)
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Arm title
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nilotinib | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Nilotinib
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
600mg daily (taken as 300mg BD)
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End points reporting groups
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Reporting group title |
Imatinib
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Reporting group description |
- | ||
Reporting group title |
nilotinib
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Reporting group description |
- | ||
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End point title |
Major molecular response (MMR) [1] | |||||||||
End point description |
This study was terminated prior to the recruitment of any participants, therefore no end point data was collected. As a result, where '9999999' is entered this means the data point is N/A.
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End point type |
Primary
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End point timeframe |
Major molecular response (MMR) at 3 years on trial
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This study was terminated prior to the recruitment of any participants, therefore no end point data is available. As a result, where '9999999' is entered within the EudraCT report, this means the data point is N/A. |
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| Notes [2] - Study terminated prior to the recruitment of any participants, therefore no end point data available [3] - Study terminated prior to the recruitment of any participants, therefore no end point data available |
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| No statistical analyses for this end point | ||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
This study was terminated prior to the recruitment of any participants, therefore no results are available and no adverse events were reported. As a result, where '9999999' is entered this means the data point is N/A.
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Assessment type |
Systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
Protocol | ||
Dictionary version |
2
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| Frequency threshold for reporting non-serious adverse events: 0% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: This study was terminated prior to the recruitment of any participants, therefore no AEs were reported. As a result, where '9999999' is entered this means the data point is N/A. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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29 Jan 2016 |
Protocol amendment to update cardiovascular safety profile. To incorporate another TKI (dasatinib) into the trial design as a first line treatment.
To include the TKI bosutinib as an option for participants who do not tolerate their first line medication. To make changes and additions to the participant-facing documentation.
(Following submission of this amendment, the trial was later terminated before recruitment was initiated). |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
