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    Clinical Trial Results:
    A phase II open-label study to determine the safety and anti-leukemic effects of STI571 in patients with Philadelphia chromosome-positive chronic myeloid leukemia in myeloid blast crisis extended for in total of 11 years (Extension 1: 2002-2004 and Extension 2: 2004- 2013)

    Summary
    EudraCT number
    		 2005-001380-61
    Trial protocol
    		 IT  
    Global end of trial date
    22 Apr 2013

    Results information
    Results version number
    		 v1
    This version publication date
    28 Jul 2018
    First version publication date
    28 Jul 2018
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    CSTI571A0102E2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00171158
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, +41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, +41 613241111,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Apr 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Apr 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To enable patients to have access to study drug, continue study treatment and to decrease data collection to include overall survival and serious adverse events.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Mar 2004
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 17
    Country: Number of subjects enrolled
    Germany: 62
    Country: Number of subjects enrolled
    Switzerland: 5
    Country: Number of subjects enrolled
    United Kingdom: 35
    Country: Number of subjects enrolled
    United States: 126
    Country: Number of subjects enrolled
    Italy: 15
    Worldwide total number of subjects
    260
    EEA total number of subjects
    129
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    199
    From 65 to 84 years
    61
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Patients recruited were adults with Philadelphia chromosome-positive (Ph+) CML transformed into myeloid BC. Patients that completed extension study #1 could enter into the extension study #2.

    Period 1
    Period 1 title
    Overall Trial
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 All subjects
    Arm description
    		 STI571 was originally provided in capsule form in 100 mg strength. STI571 will be supplied as tablets instead of capsules. Patients will continue to use capsules until the supply of capsules is finished and are supplied with tablets. The capsules and tablets are bioequivalent. The initial dose was either 400 mg once daily or 600 mg once daily. Dosage increase from 400 mg once daily to 600 mg once daily and from 600 mg once daily to 800 mg once daily was permitted in all patients for improved therapeutic effect.
    Arm type
    		 Experimental

    Investigational medicinal product name
    STI571
    Investigational medicinal product code
    Other name
    imatinib, Glivec®, Gleevec®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    STI571 was supplied as 25 mg, 50 mg and 100 mg tablets, taken orally, once a day with 250 ml of water after breakfast for 400 mg/day and 600 mg/day doses, or twice a day after breakfast and the evening meal for 800 mg/day (2 x 400 mg/day) dose.

    Number of subjects in period 1
    		All subjects
    Started
    260
    Still on treatment
    21
    Completed
    21
    Not completed
    239
         No longer required drug (BMT)
    14
         Consent withdrawn by subject
    6
         Adverse event, non-fatal
    21
         Protocol violation
    4
         Death
    27
         Unsatisfactory therapeutic effect
    163
         Administrative problems
    1
         Abnormal laboratory values
    2
         Lost to follow-up
    1
    Period 2
    Period 2 title
    Overall Trial - E2 extension
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 All subjects - Extension phase
    Arm description
    		 STI571 was provided in capsule form in 100 mg strength. STI571 will be supplied as tablets instead of capsules. Patients will continue to use capsules until the supply of capsules is finished and are supplied with tablets. The capsules and tablets are bioequivalent. The initial dose was either 400 mg once daily or 600 mg once daily. Dosage increase from 400 mg once daily to 600 mg once daily and from 600 mg once daily to 800 mg once daily was permitted in all patients for improved therapeutic effect.
    Arm type
    		 Experimental

    Investigational medicinal product name
    STI571
    Investigational medicinal product code
    imatinib mesylate
    Other name
    imatinib, Glivec®, Gleevec®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    STI571 was supplied as 25 mg, 50 mg and 100 mg tablets, taken orally, once a day with 250 ml of water after breakfast for 400 mg/day and 600 mg/day doses, or twice a day after breakfast and the evening meal for 800 mg/day (2 x 400 mg/day) dose.

    Number of subjects in period 2 [1]
    		All subjects - Extension phase
    Started
    8
    Completed
    1
    Not completed
    7
         Unknown reason
    7
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: In Extension 1 (E1) of the study, 13 subjects discontinued. Reasons are unknown.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 260 260
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 199 199
        From 65-84 years
    		 61 61
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 56 (19 to 81) -
    Gender categorical
    Units: Subjects
        Female
    		 124 124
        Male
    		 136 136

    End points

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    End points reporting groups
    Reporting group title
    All subjects
    Reporting group description
    		 STI571 was originally provided in capsule form in 100 mg strength. STI571 will be supplied as tablets instead of capsules. Patients will continue to use capsules until the supply of capsules is finished and are supplied with tablets. The capsules and tablets are bioequivalent. The initial dose was either 400 mg once daily or 600 mg once daily. Dosage increase from 400 mg once daily to 600 mg once daily and from 600 mg once daily to 800 mg once daily was permitted in all patients for improved therapeutic effect.
    Reporting group title
    All subjects - Extension phase
    Reporting group description
    		 STI571 was provided in capsule form in 100 mg strength. STI571 will be supplied as tablets instead of capsules. Patients will continue to use capsules until the supply of capsules is finished and are supplied with tablets. The capsules and tablets are bioequivalent. The initial dose was either 400 mg once daily or 600 mg once daily. Dosage increase from 400 mg once daily to 600 mg once daily and from 600 mg once daily to 800 mg once daily was permitted in all patients for improved therapeutic effect.

    Primary: Summary overall survival (ITT)

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    End point title
    		 Summary overall survival (ITT) [1]
    End point description
    Overall survival was defined as the time from first dose of STI571 to death of the patient.
    End point type
    Primary
    End point timeframe
    From first dose until death of the patient, up to 11 years.
    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: No statistical analyses have been reported for this primary end point
    End point values
    		 All subjects
    Number of subjects analysed
    260 [2]
    Units: Number of events (%)
    number (not applicable)
        All patients
    89.2
    Notes
    [2] - Intent-to-treat (ITT) population.
    No statistical analyses for this end point

    Primary: Summary of overall survival (by month)

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    End point title
    		 Summary of overall survival (by month) [3]
    End point description
    Kaplan-Meier estimates per month.
    End point type
    Primary
    End point timeframe
    From first dose until death of the patient, up to 11 years.
    Notes
    [3] - 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: No statistical analyses have been reported for this primary end point
    End point values
    		 All subjects
    Number of subjects analysed
    260 [4]
    Units: percentage f participants
    number (confidence interval 95%)
        12 months
    32.7 (27.0 to 38.5)
        24 months
    18.7 (14.2 to 23.8)
        36 months
    15.4 (11.2 to 20.2)
        48 months
    14.5 (10.4 to 19.2)
        60 months
    9.1 (5.7 to 13.4)
        72 months
    8.4 (5.2 to 12.7)
        84 months
    7.5 (4.3 to 11.8)
        96 months
    7.5 (4.3 to 11.8)
        108 months
    7.5 (4.3 to 11.8)
        120 months
    6.6 (3.5 to 11.0)
        132 months
    5.5 (2.6 to 10.0)
    Notes
    [4] - Intent-to-treat (ITT) population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
    Adverse event reporting additional description
    After 31-Jul-2002 no safety data was collected in the clinical database and Serious adverse events (SAEs) were reported in the safety database. No drug-related SAEs leading to discontinuation or drug-related deaths were reported after 31-Jul-2002 in the safety database.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    All subjects
    Reporting group description
    		 STI571 was originally provided in capsule form in 100 mg strength. STI571 will be supplied as tablets instead of capsules. Patients will continue to use capsules until the supply of capsules is finished and are supplied with tablets. The capsules and tablets are bioequivalent. The initial dose was either 400 mg once daily or 600 mg once daily. Dosage increase from 400 mg once daily to 600 mg once daily and from 600 mg once daily to 800 mg once daily was permitted in all patients for improved therapeutic effect.

    Serious adverse events
    		 All subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 All subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    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: After 31-Jul-2002 no safety data was collected in the clinical database and Serious adverse events (SAEs) were reported in the safety database.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Mar 2004
    To allow patients to receive study drug for as long as the patient should require it. Also, it changed the frequency of bone marrow cytogenetics for those patients maintaining a complete cytogenetic response to annually from twice yearly until the patient reached month 48 of the extension or 31-July-2006, whichever date came first.
    01 Mar 2008
    To accommodate patient site visits on a yearly (±3 months) basis rather than every six months. In addition, a new section was added to include new protocol deviation language which stated that under no circumstances were protocol deviations allowed.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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