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    Clinical Trial Results:
    A “window of opportunity” trial with Brentuximab Vedotin and Imatinib in patients with relapsed or refractory ALK+ anaplastic large cell lymphoma or patients ineligible for chemotherapy

    Summary
    EudraCT number
    		 2013-003505-26
    Trial protocol
    		 AT  
    Global end of trial date
    03 Nov 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Jul 2022
    First version publication date
    16 Jul 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AGMT_ALCL1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02462538
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AGMT
    Sponsor organisation address
    Gentzgasse 60/21, Vienna, Austria, 1180
    Public contact
    Daniela Wolkersdorfer, AGMT, 0043 6626404412, d.wolkersdorfer@agmt.at
    Scientific contact
    Richard Greil, AGMT, 0043 5725525801, r.greil@salk.at
    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
    03 Nov 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Nov 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To determine the safety and tolerability of simultaneous administration of brentuximab vedotin and imatinib mesylate in substitution of conventional chemotherapeutic treatment.
    Protection of trial subjects
    Safety measurements were assessed at screening, every 3 weeks during and at the end of treatment, and at final visit. All (serious) adverse events occurring during study treatment were collected from signing the informed consent form until 12 weeks after the end of study treatment. In general, concomitant medications and therapies necessary for supportive care and safety of the patient are allowed: Because of the inherent risk of either reduced activity or enhanced toxicity of the concomitant medication and/or imatinib, drugs known to interact with the same CYP450 isoenzymes (2D and 3A4) as imatinib or MMAE should have been used with caution.
    Background therapy
    		 None.
    Evidence for comparator
    		 Not applicable.
    Actual start date of recruitment
    16 Mar 2015
    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
    Austria: 3
    Worldwide total number of subjects
    3
    EEA total number of subjects
    3
    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)
    3
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between 03-Nov-2015 and 26-September-2017 three patients were enrolled at one site in Austria.

    Pre-assignment
    Screening details
    		 Due to low recruitment study was withdrawn prematurely after inclusion of three patients on 22-Mar-2018. At time of this decision, no patients were on study treatment. Planned follow up phase was conducted and ended on 03-Nov-2021.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Overall trial
    Arm description
    		 Combination therapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    Brentuximab vedotin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Starting dose of brentuximab vedotin 1.8 mg/kg; cycles were repeated every 3 weeks up to 48 weeks (last administration: d1 week 45)

    Investigational medicinal product name
    Imatinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100mg daily starting from day 1 of the first cycle; increased to 200mg daily starting from day 1 of the second cycle; continued at 200mg for 48 weeks

    Number of subjects in period 1
    		Overall trial
    Started
    3
    Completed
    1
    Not completed
    2
         Adverse event, non-fatal
    1
         Progressive disease
    1

    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
    		 3 3
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Age at enrollment
    Units: years
        median (full range (min-max))
    		 26 (24 to 47) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 3 3
    Prior ALCL therapies
    Units: Subjects
        1 prior therapy
    		 2 2
        3 prior therapies
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 Combination therapy

    Primary: Safety and tolerability

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    End point title
    		 Safety and tolerability [1]
    End point description
    Due to small sample size, no evaluation of tolerability can be given, results are tabulated only.
    End point type
    Primary
    End point timeframe
    60 weeks - from enrollment to final visit 12 weeks after discontinuing or completion of study treatment
    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: Main aim of this phase I/II pilot study is feasibility and safety. No formal hypothesis testing was planned.
    End point values
    		 Overall trial
    Number of subjects analysed
    3
    Units: Subjects
        Withdrawal due to AE
    1
        No withdrawal due to AE
    2
    No statistical analyses for this end point

    Secondary: Clinical response rate

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    End point title
    		 Clinical response rate
    End point description
    End point type
    Secondary
    End point timeframe
    Response at final visit (12 weeks after discontinuing or completion of study treatment)
    End point values
    		 Overall trial
    Number of subjects analysed
    3
    Units: Subjects
        Complete remission
    2
        Partial remission
    0
        Stable disease
    0
        Progressive disease
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From inclusion of patient until final visit (12 weeks after completion or discontinuation of study treatment)
    Adverse event reporting additional description
    According to protocol, an abnormal laboratory value was not assessed as an AE unless that value led to discontinuation or delay in treatment, dose modification, therapeutic intervention. Progression of disease was not to be regarded as SAE. Relation to IMP brentuximab vedotin is given.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 All enrolled patients

    Serious adverse events
    		 Overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 3 (66.67%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Gastrointestinal disorders
    Oesophagitis
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    Investigations
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    3 / 3 (100.00%)
         occurrences all number
    7
    Neutrophil count decreased
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Nervous system disorders
    Seizure
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Polyneuropathy
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    General disorders and administration site conditions
    Stenosis
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Generalised oedema
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    2 / 3 (66.67%)
         occurrences all number
    2
    Diarrhoea
         subjects affected / exposed
    2 / 3 (66.67%)
         occurrences all number
    2
    Nausea
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Ascites
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Abdominal pain
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Hepatobiliary disorders
    Cholestasis
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    2
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Joint swelling
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Arthritis reactive
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Infections and infestations
    Dermatophytosis
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    2
    Nasopharyngitis
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Influenza
         subjects affected / exposed
    2 / 3 (66.67%)
         occurrences all number
    2
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    Recruitment was withdrawn prematurely due to very slow recruitment. Three patients were enrolled, planned sample size of 10 patients was not reached.
    For support, Contact us.
    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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