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    Clinical Trial Results:
    Long-term Follow-up of Adult Philadelphia Chromosome-negative Acute Lymphoblastic Leukemia Relapsed Refractory Patients Enrolled in Study 00103311

    Summary
    EudraCT number
    		 2019-001575-37
    Trial protocol
    		 DE   IT  
    Global end of trial date
    07 Sep 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Jul 2021
    First version publication date
    07 Jul 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    20180138
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Amgen Inc.
    Sponsor organisation address
    One Amgen Center Drive, Thousand Oaks, CA, United States,
    Public contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.com
    Scientific contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.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
    07 Sep 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Sep 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study was to conduct a one-time survival status assessment on participants who were alive at the last follow-up and still participating in the phase III study 00103311. The single output from this study effort was to generate an updated overall survival (OS) Kaplan-Meier (KM) probability estimates and KM plot.
    Protection of trial subjects
    This study will comply with all applicable laws regarding subject privacy. No direct participant contact or collection of additional data from participants will occur beyond survival status assessment and blinatumomab use for participants in the standard of care arm after the conclusion of the 00103311 study by the sites. Study results will be in tabular form and aggregate analyses that omits participant identification. Any publications and reports will not include participant identifiers.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Dec 2019
    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
    Australia: 5
    Country: Number of subjects enrolled
    Austria: 2
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    Bulgaria: 1
    Country: Number of subjects enrolled
    Canada: 7
    Country: Number of subjects enrolled
    Czechia: 6
    Country: Number of subjects enrolled
    France: 7
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    Greece: 2
    Country: Number of subjects enrolled
    Ireland: 1
    Country: Number of subjects enrolled
    Israel: 1
    Country: Number of subjects enrolled
    Italy: 14
    Country: Number of subjects enrolled
    Poland: 2
    Country: Number of subjects enrolled
    Taiwan: 3
    Country: Number of subjects enrolled
    Turkey: 1
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    United States: 6
    Country: Number of subjects enrolled
    Spain: 6
    Worldwide total number of subjects
    75
    EEA total number of subjects
    51
    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)
    67
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study included 75 eligible participants that were alive at the last follow-up and still participating in the phase III study 00103311 when 00103311 ended earlier than planned. Data was collected from 02 December 2019 to 07 September 2020.

    Pre-assignment
    Screening details
    		 At the last follow up in study 00103311, 108 participants were alive and participating at the end of study. Of these participants, 75 were eligible for enrolment into study 20180138. Enrolment was not achieved for 33 participants due to no participation of study centres (24) or no enrolment of participants at active study centres (9).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Standard of care (SOC) chemotherapy
    Arm description
    		 All participants who received SOC chemotherapy in study 00103311, and who were alive at the end of 00103311 and assessed for survival status in study 20180138.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    SOC chemotherapy
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants were administered SOC chemotherapy in study 00103311.

    Arm title
    		 Blinatumomab
    Arm description
    		 All participants who received blinatumomab in study 00103311, and who were alive at the end of 00103311 and assessed for survival status in study 20180138.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Blinatumomab
    Investigational medicinal product code
    Other name
    Blincyto®
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received blinatumomab in study 00103311.

    Number of subjects in period 1
    		Standard of care (SOC) chemotherapy Blinatumomab
    Started
    19
    56
    Completed
    19
    56

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Standard of care (SOC) chemotherapy
    Reporting group description
    		 All participants who received SOC chemotherapy in study 00103311, and who were alive at the end of 00103311 and assessed for survival status in study 20180138.

    Reporting group title
    Blinatumomab
    Reporting group description
    		 All participants who received blinatumomab in study 00103311, and who were alive at the end of 00103311 and assessed for survival status in study 20180138.

    Reporting group values
    		 Standard of care (SOC) chemotherapy Blinatumomab Total
    Number of subjects
    		 19 56 75
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 18 49 67
        From 65-84 years
    		 1 7 8
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 36.4 ± 16.0 42.1 ± 17.5 -
    Gender Categorical
    Units: Subjects
        Female
    		 7 26 33
        Male
    		 12 30 42
    Ethnicity
    Units: Subjects
        Hispanic/Latino
    		 1 3 4
        Not Hispanic/Latino
    		 17 53 70
        Unknown
    		 1 0 1
    Race
    Units: Subjects
        Asian
    		 1 2 3
        Other
    		 4 1 5
        White
    		 14 53 67

    End points

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    End points reporting groups
    Reporting group title
    Standard of care (SOC) chemotherapy
    Reporting group description
    		 All participants who received SOC chemotherapy in study 00103311, and who were alive at the end of 00103311 and assessed for survival status in study 20180138.

    Reporting group title
    Blinatumomab
    Reporting group description
    		 All participants who received blinatumomab in study 00103311, and who were alive at the end of 00103311 and assessed for survival status in study 20180138.

    Primary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS) [1]
    End point description
    OS was defined as the time from randomization to the blinatumomab arm or SOC chemotherapy arm in study 00103311 until death or censoring at the last date known to be alive. Participants still alive were censored at the date they were last known to be alive. OS was estimated using KM probability estimate. Median OS is presented as an update to the full analysis set (FAS) OS data from study 00103311, so includes data collected in study 00103311, where n = 405.
    End point type
    Primary
    End point timeframe
    From randomization in study 00103311 up to approximately 60 months
    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 formal statistical analysis was planned.
    End point values
    		 Standard of care (SOC) chemotherapy Blinatumomab
    Number of subjects analysed
    19 [2]
    56 [3]
    Units: Months
        median (confidence interval 95%)
    4.0 (2.9 to 5.5)
    7.6 (5.6 to 9.4)
    Notes
    [2] - Median OS is presented as an update to the FAS OS data from study 00103311 where n = 134
    [3] - Median OS is presented as an update to the FAS OS data from study 00103311 where n = 271
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    0 days
    Adverse event reporting additional description
    Serious and non-serious adverse events were not collected for this study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NA
    Dictionary version
    NA
    Frequency threshold for reporting non-serious adverse events: 5%
    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: Serious and non-serious adverse events were not collected for this study

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Aug 2019
    The following changes were made: * Added Signature page (Investigator’s Agreement), amendments and updates, and list of abbreviations sections to the protocol * Clarified language regarding data collection in 'Study Population and Methods' section * Added section for safety outcome assessment * Added language regarding sensitivity analysis * Added safety reporting language and applicable safety forms since study has changed to include primary and secondary data collection * Added “Protection of Human Subjects” and “Administrative and Legal Obligations” sections to the protocol * Made editorial and administrative changes for grammatical reasons as well as for internal consistency within the protocol.

    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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