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    Clinical Trial Results:
    Open-Label Single Arm Phase 2 Study Evaluating Dasatinib Therapy Discontinuation In Patients With Chronic Phase Chronic Myeloid Leukemia (CP-CML) With Stable Complete Molecular Response (CMR) DASFREE

    Summary
    EudraCT number
    2012-001421-27
    Trial protocol
    FI   ES   IT   DE  
    Global end of trial date
    08 Oct 2021

    Results information
    Results version number
    v1(current)
    This version publication date
    21 Oct 2022
    First version publication date
    21 Oct 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CA180-406
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussee de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.com
    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
    01 Dec 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Oct 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to assess the rate of major molecular response (MMR), defined as the proportion of subjects who maintain MMR (BCR-ABL transcripts < 0.1% on International Scale (IS) at 12 months after dasatinib discontinuation, without re-starting dasatinib treatment.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial participants were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    22 Jan 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 12
    Country: Number of subjects enrolled
    France: 5
    Country: Number of subjects enrolled
    Germany: 7
    Country: Number of subjects enrolled
    Italy: 11
    Country: Number of subjects enrolled
    Spain: 23
    Country: Number of subjects enrolled
    United States: 26
    Worldwide total number of subjects
    84
    EEA total number of subjects
    46
    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)
    64
    From 65 to 84 years
    20
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    110 participants were screened. 26 failed to meet eligibility and 84 participants proceeded to receive study treatment.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Total
    Arm description
    At study entry, dasatinib will be discontinued in all enrolled participants. Dasatinib will be restarted if major molecular response is lost during the off-treatment period at the dose level received before study entry. The participant will remain on treatment for the duration of the study. Dose adjustment for toxicity and response is permitted during the retreatment period based on protocol guidelines. Dosing above 180 mg per day of dasatinib is prohibited.
    Arm type
    Experimental

    Investigational medicinal product name
    Dasatinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20 mg, 50 mg, 80 mg, 100 mg, and 140 mg Tablets

    Number of subjects in period 1
    Total
    Started
    84
    Restarted Treatment
    47 [1]
    Discontinued Treatment after Restart
    47 [2]
    Completed
    60
    Not completed
    24
         Participant No Longer Meets Study Criteria
    1
         Other Reasons
    2
         Participant Request to Discontinue Treatment
    2
         Maximum Clinical Benefit
    4
         Adverse Event Unrelated to Study Drug
    1
         Poor/Non-compliance
    1
         Participant Withdrew Consent
    9
         Adverse Event Related to Study Drug
    4
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This number reflects the number of participants who restarted treatment after failure to maintain major molecular response.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This number reflects the number of participants who restarted treatment after failure to maintain major molecular response.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Total
    Reporting group description
    At study entry, dasatinib will be discontinued in all enrolled participants. Dasatinib will be restarted if major molecular response is lost during the off-treatment period at the dose level received before study entry. The participant will remain on treatment for the duration of the study. Dose adjustment for toxicity and response is permitted during the retreatment period based on protocol guidelines. Dosing above 180 mg per day of dasatinib is prohibited.

    Reporting group values
    Total Total
    Number of subjects
    84 84
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    64 64
        From 65-84 years
    20 20
        85 years and over
    0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    52.6 ± 14.57 -
    Sex: Female, Male
    Units:
        Female
    37 37
        Male
    47 47
    Race/Ethnicity, Customized
    Units: Subjects
        White
    75 75
        Black/African American
    3 3
        Asian
    1 1
        Other
    5 5

    End points

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    End points reporting groups
    Reporting group title
    Total
    Reporting group description
    At study entry, dasatinib will be discontinued in all enrolled participants. Dasatinib will be restarted if major molecular response is lost during the off-treatment period at the dose level received before study entry. The participant will remain on treatment for the duration of the study. Dose adjustment for toxicity and response is permitted during the retreatment period based on protocol guidelines. Dosing above 180 mg per day of dasatinib is prohibited.

    Primary: Major Molecular Response (MMR) Rate

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    End point title
    Major Molecular Response (MMR) Rate [1]
    End point description
    Major Molecular Response (MMR) rate at 12 months is the percentage of participants who maintain MMR (BCR-ABL transcripts < 0.1% on the International Scale [IS]) at 12 months after Dasatinib discontinuation without restarting Dasatinib
    End point type
    Primary
    End point timeframe
    At 12 months after Dasatinib discontinuation (assessed up to approximately June 4, 2018)
    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: Only summary statistics were planned for this endpoint
    End point values
    Total
    Number of subjects analysed
    84
    Units: Percentage of Participants
        number (confidence interval 95%)
    47.6 (36.6 to 58.8)
    No statistical analyses for this end point

    Secondary: Event-Free Survival (EFS) Rate

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    End point title
    Event-Free Survival (EFS) Rate
    End point description
    Event-free survival (EFS) rate is defined as the percentage of surviving participants with no loss of Major Molecular Response (MMR) at the specified timepoints after dasatinib discontinuation. MMR is defined as BCR-ABL transcripts < 0.1% IS. Loss of MMR is defined per the European LeukemiaNet (ELN) definition of progression. Progression is defined as Transformation to Accelerated Phase or Blast Crisis (AP/BC): Accelerated Phase (AP) Blasts in PB or BM 15–29%; Blast + promyelocytes ≥ 30% with blasts < 30% or ACA in Ph+ cells (clonal progression), or basophils in blood ≥ 20%,or platelets < 100 x 10^9 /L unrelated to therapy Blastic Phase or Crisis (BP/BC) Blasts in PB or BM ≥ 30%, or extramedullary blast cell involvement (with exception of spleen and liver) The date of progression is defined as the date any of the above criteria is first met. Participants who have not progressed will be censored on the date of last examination.
    End point type
    Secondary
    End point timeframe
    From 12 months after Dasatinib treatment discontinuation to every 12 months thereafter (up to approximately 60 months)
    End point values
    Total
    Number of subjects analysed
    84
    Units: Percentage of participants
    number (confidence interval 95%)
        At 12 months
    48.7 (38.0 to 59.4)
        At 24 months
    46.3 (35.6 to 57.0)
        At 36 months
    45.0 (34.3 to 55.7)
        At 48 months
    43.8 (33.1 to 54.4)
        At 60 months
    43.8 (33.1 to 54.4)
    No statistical analyses for this end point

    Secondary: Relapse-Free Survival (RFS) Rate

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    End point title
    Relapse-Free Survival (RFS) Rate
    End point description
    RFS is the percentage of participants who did not relapse at the specified timepoints. Participants who did not relapse were censored on the date of their last molecular assessment. Relapse is defined as any of the following events while on study: the loss of Major Molecular Response (MMR), loss of Complete Cytogenetic Response (CCyR), loss of Complete Hematologic Response (CHR) or progression to advanced/blastic phase. MMR is defined as BCR-ABL transcripts < 0.1% IS. Cytogenetic response (CyR) is based on the prevalence of Ph+ cells in metaphase from bone marrow (BM) sample based on evaluation of at least 20 metaphases. CCyR is defined as 0% Ph+ cells in metaphase in BM. CHR is obtained when all the following criteria are met in peripheral blood (PB) sampling: white blood cell ≤10,000/mm3; Platelets < 450,000/mm3; PB basophils <5%; No blasts or promyelocytes in PB; <5% myelocytes plus metamyelocytes in PB; No extramedullary involvement (including no hepatomegaly or splenomegaly).
    End point type
    Secondary
    End point timeframe
    From 12 months after Dasatinib treatment discontinuation to every 6 months thereafter (up to approximately 60 months)
    End point values
    Total
    Number of subjects analysed
    84
    Units: Percentage of Participants
    number (confidence interval 95%)
        At 6 Months
    61.9 (51.5 to 72.3)
        At 12 Months
    48.7 (38.0 to 59.4)
        At 18 Months
    47.5 (36.8 to 58.2)
        At 24 months
    46.3 (35.6 to 57.0)
        At 30 months
    46.3 (35.6 to 57.0)
        At 36 months
    45.0 (34.4 to 55.7)
        At 42 months
    43.8 (33.1 to 54.4)
        At 48 months
    43.8 (33.1 to 54.4)
        At 54 months
    43.8 (33.1 to 54.4)
        At 60 months
    43.8 (33.1 to 54.4)
    No statistical analyses for this end point

    Secondary: Progression Free Survival (PFS) Rate

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    End point title
    Progression Free Survival (PFS) Rate
    End point description
    Progression free survival (PFS) is defined as the percentage of participants who experienced death (due to any cause) or accelerated phase, or blast crisis. Participants who neither progress nor die will be censored on the date of their last molecular assessment. Progression is defined as Transformation to Accelerated Phase or Blast Crisis (AP/BC) Accelerated Phase (AP) Blasts in PB or BM 15–29%; Blast + promyelocytes >= 30% with blasts < 30% or ACA in Ph+ cells (clonal progression), or basophils in blood >= 20%,or platelets < 100 x 109 /L unrelated to therapy Blastic Phase or Crisis (BP/BC) Blasts in PB or BM >= 30%, or extramedullary blast cell involvement (with the exception of spleen and liver)
    End point type
    Secondary
    End point timeframe
    From 12 months after Dasatinib treatment discontinuation to every 6 months thereafter (up to approximately 60 months)
    End point values
    Total
    Number of subjects analysed
    84
    Units: Percentage of participants
    number (confidence interval 95%)
        At 6 months
    100.0 (100.0 to 100.0)
        At 12 months
    100.0 (100.0 to 100.0)
        At 18 months
    100.0 (100.0 to 100.0)
        At 24 months
    98.7 (96.2 to 100.0)
        At 30 months
    98.7 (96.2 to 100.0)
        At 36 months
    98.7 (96.2 to 100.0)
        At 42 months
    98.7 (96.2 to 100.0)
        At 48 months
    98.7 (96.2 to 100.0)
        At 54 months
    98.7 (96.2 to 100.0)
        At 60 months
    98.7 (96.2 to 100.0)
    No statistical analyses for this end point

    Secondary: Number of participants who experience intermittent loss of complete molecular response (CMR) (MR4.5) but no loss of major molecular response (MMR)

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    End point title
    Number of participants who experience intermittent loss of complete molecular response (CMR) (MR4.5) but no loss of major molecular response (MMR)
    End point description
    The number of participants who did not lose major molecular response (MMR) 60 months after discontinuing study treatment who were in MR4.5 at the time of discontinuation and lost MR4.5. Molecular response will be assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (Q-PCR). MMR is defined as BCR-ABL transcripts < 0.1% Internal Standard (IS). CMR (MR4.5) defined as ≤ 0.0032% (IS) or ≥ 4.5 log reduction of BCR-ABL transcript levels molecular response.
    End point type
    Secondary
    End point timeframe
    60 months after last dose
    End point values
    Total
    Number of subjects analysed
    31
    Units: Participants
    19
    No statistical analyses for this end point

    Secondary: Number of participants who did not experience loss of complete molecular response (CMR) (MR4.5) and major molecular response (MMR)

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    End point title
    Number of participants who did not experience loss of complete molecular response (CMR) (MR4.5) and major molecular response (MMR)
    End point description
    Assessment of BCR-ABL kinetics in patients who are in CMR (MR4.5) or less when transcript levels are still measurable. CMR (MR4.5) defined as ≤ 0.0032% (IS) or ≥ 4.5 log reduction of BCR-ABL transcript levels molecular response.
    End point type
    Secondary
    End point timeframe
    From 12 months after Dasatinib treatment discontinuation to 5 years after the first visit of the last enrolled participant (up to approximately 82 months)
    End point values
    Total
    Number of subjects analysed
    31
    Units: Participants
    12
    No statistical analyses for this end point

    Secondary: Time to transformation to accelerated phase/blast crisis (AP/BC)

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    End point title
    Time to transformation to accelerated phase/blast crisis (AP/BC)
    End point description
    Time to Transformation to AP/BC is defined as the rate at which participants experienced transformation to accelerated phase/blast crisis (AP/BC) since discontinuation. Participants who did not develop to AP, late phase, or BC phase were censored on their last molecular measurement date. "99999"=N/A
    End point type
    Secondary
    End point timeframe
    From 12 months after Dasatinib treatment discontinuation to 5 years after the first visit of the last enrolled participant (up to approximately 82 months)
    End point values
    Total
    Number of subjects analysed
    84
    Units: Months
        median (confidence interval 95%)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    Overall Survival (OS)
    End point description
    Time to Transformation to AP/BC is defined as the rate at which participants experienced transformation to accelerated phase/blast crisis (AP/BC) since discontinuation. Participants who did not develop to AP, late phase, or BC phase were censored on their last molecular measurement date. "99999"=N/A
    End point type
    Secondary
    End point timeframe
    From 12 months after Dasatinib treatment discontinuation to the date of death or last known alive date (up to approximately 82 months)
    End point values
    Total
    Number of subjects analysed
    84
    Units: Months
        median (confidence interval 95%)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Progression Free Survival

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    End point title
    Progression Free Survival
    End point description
    Progression-free survival (PFS) is defined as the time from treatment discontinuation to the date of progression or death (due to any cause), whichever occurs first. Participants who neither progress nor die will be censored on the date of their last molecular assessment. "99999"=N/A
    End point type
    Secondary
    End point timeframe
    From treatment discontinuation to the date of progression or death due to any cause, whichever occurs first (up to 82 months)
    End point values
    Total
    Number of subjects analysed
    84
    Units: Months
        median (confidence interval 95%)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months).
    Adverse event reporting additional description
    The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    DASATINIB
    Reporting group description
    At study entry, dasatinib will be discontinued in all enrolled participants. Dasatinib will be restarted if major molecular response is lost during the off-treatment period at the dose level received before study entry. The participant will remain on treatment for the duration of the study. Dose adjustment for toxicity and response is permitted during the retreatment period based on protocol guidelines. Dosing above 180 mg per day of dasatinib is prohibited.

    Serious adverse events
    DASATINIB
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 47 (17.02%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ovarian cancer metastatic
         subjects affected / exposed
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Prostate cancer
         subjects affected / exposed
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Myocardial ischaemia
         subjects affected / exposed
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pericarditis
         subjects affected / exposed
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Ear and labyrinth disorders
    Deafness
         subjects affected / exposed
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Polychondritis
         subjects affected / exposed
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    External ear cellulitis
         subjects affected / exposed
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    DASATINIB
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    42 / 47 (89.36%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    4 / 47 (8.51%)
         occurrences all number
    5
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 47 (6.38%)
         occurrences all number
    4
    Headache
         subjects affected / exposed
    6 / 47 (12.77%)
         occurrences all number
    8
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    3 / 47 (6.38%)
         occurrences all number
    5
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    5 / 47 (10.64%)
         occurrences all number
    5
    Pyrexia
         subjects affected / exposed
    4 / 47 (8.51%)
         occurrences all number
    4
    Oedema peripheral
         subjects affected / exposed
    3 / 47 (6.38%)
         occurrences all number
    5
    Fatigue
         subjects affected / exposed
    10 / 47 (21.28%)
         occurrences all number
    12
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    6 / 47 (12.77%)
         occurrences all number
    7
    Diarrhoea
         subjects affected / exposed
    4 / 47 (8.51%)
         occurrences all number
    9
    Dry mouth
         subjects affected / exposed
    3 / 47 (6.38%)
         occurrences all number
    3
    Haemorrhoids
         subjects affected / exposed
    4 / 47 (8.51%)
         occurrences all number
    4
    Vomiting
         subjects affected / exposed
    3 / 47 (6.38%)
         occurrences all number
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 47 (8.51%)
         occurrences all number
    4
    Dyspnoea
         subjects affected / exposed
    3 / 47 (6.38%)
         occurrences all number
    3
    Pleural effusion
         subjects affected / exposed
    4 / 47 (8.51%)
         occurrences all number
    10
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    5 / 47 (10.64%)
         occurrences all number
    7
    Psychiatric disorders
    Depression
         subjects affected / exposed
    3 / 47 (6.38%)
         occurrences all number
    3
    Insomnia
         subjects affected / exposed
    3 / 47 (6.38%)
         occurrences all number
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    7 / 47 (14.89%)
         occurrences all number
    8
    Back pain
         subjects affected / exposed
    4 / 47 (8.51%)
         occurrences all number
    5
    Myalgia
         subjects affected / exposed
    6 / 47 (12.77%)
         occurrences all number
    8
    Pain in extremity
         subjects affected / exposed
    3 / 47 (6.38%)
         occurrences all number
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    7 / 47 (14.89%)
         occurrences all number
    11
    Sinusitis
         subjects affected / exposed
    4 / 47 (8.51%)
         occurrences all number
    4
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 47 (8.51%)
         occurrences all number
    5
    Viral infection
         subjects affected / exposed
    3 / 47 (6.38%)
         occurrences all number
    3
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    3 / 47 (6.38%)
         occurrences all number
    4

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Nov 2013
    Edits to requirements for women of childbearing age; correction of EudraCT number
    02 Mar 2015
    Updates to eligibility criteria; second level of dose escalation to 180 mg dasatinib added; updates to ECG monitoring; bone marrow biopsy or aspirate or peripheral blood (FISH) for cytogenetic assessment no longer required as part of the baseline assessments; changes in the study stopping rule incorporated; corrections to assessment of response free survival and frequency of safety and efficacy review.
    22 Mar 2016
    Hepatitis B serology status now required; revised method of contraception guidelines; destruction of study drug now permitted per protocol requirements
    24 Jul 2017
    Added new exploratory endpoint; updated event free survival definition and timeframe; BCR-ABL kinetics analysis updated; clarification in the frequency of complete blood count (CBC) and platelet assessments; statistical section updated for consistency with the statistical analysis plan

    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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