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    Clinical Trial Results:
    Phase II multicentric study to evaluate the efficacy and the safety of Bendamustine in adjunct to Etoposide, Aracytabin and Melphalan (BeEAM) as a preparative regimen for autologous stem cell transplantation in refractory/relapsed aggressive B-cell non-Hodgkin lymphoma patients.

    Summary
    EudraCT number
    		 2011-001246-14
    Trial protocol
    		 IT  
    Global end of trial date
    22 Feb 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Aug 2022
    First version publication date
    26 Aug 2022
    Other versions
    Summary report(s)
    		 EBMT 2020 abstract
    Protocol synopsys

    Trial information

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    Trial identification
    Sponsor protocol code
    701
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AORMN Hospital
    Sponsor organisation address
    Piazzale Cinelli 4, Pesaro, Italy,
    Public contact
    Hematology Clinical Trial Office, Presidio Ospedaliero“San Salvatore/Ospedali Riuniti Marche Nord”, +39 0721364022, alessandro.isidori@ospedalimarchenord.it
    Scientific contact
    Hematology Clinical Trial Office, Presidio Ospedaliero“San Salvatore/Ospedali Riuniti Marche Nord”, +39 0721364022, alessandro.isidori@ospedalimarchenord.it
    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
    30 Jul 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Feb 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Feb 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the 1-year complete remission (CR) rate.
    Protection of trial subjects
    No specific measure was put in place to protect trial subjects, in addition to standard of care.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2011
    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
    Italy: 66
    Worldwide total number of subjects
    66
    EEA total number of subjects
    66
    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)
    57
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 According to Amendment 1, sent to the Italian Regulatoy Authority (AIFA)on october 20th, 2020, 66 patients were enrolled in the trial between June 2011 and november 20th, 2018. All patients were enrolled in Italy.

    Pre-assignment
    Screening details
    		 73 patients were screened. 7/73 patients did not meet one or more of the inclusion or exclusion criteria, and were consequently not enrolled in the trial. 66 patients were finally enrolled.

    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
    		 Treatment arm
    Arm description
    		 This was a single arm trial testing the the efficacy and the safety of Bendamustine in adjunct to Etoposide, Aracytabin and Melphalan (BeEAM) as a preparative regimen for autologous stem cell transplantation in refractory/relapsed aggressive B-cell non-Hodgkin lymphoma patients.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bendamustine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Bendamustine was used in adjunct to other drugs in the conditioning regimen for autologosu stem cell transplantation in resistant/refractory non Hodking lymphoma patients, as follows: • Bendamustine 200 mg/m2 on day -7 and -6 • Aracytin 400 mg/m2 from day -5 to day -2 • Etoposide 200 mg/m2 from day -5 to day -2 • Melphalan 140 mg/m2 on day -1 • Autologous stem cell transplantation on day 0

    Number of subjects in period 1
    		Treatment arm
    Started
    66
    Completed
    66

    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
    		 66 66
    Age categorical
    Patients aged 18-70 were considered to be enrolled in the trial
    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)
    		 57 57
        From 65-84 years
    		 9 9
        85 years and over
    		 0 0
    Gender categorical
    Both males and females patients were enrolled in the trial
    Units: Subjects
        Female
    		 30 30
        Male
    		 36 36

    End points

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    End points reporting groups
    Reporting group title
    Treatment arm
    Reporting group description
    		 This was a single arm trial testing the the efficacy and the safety of Bendamustine in adjunct to Etoposide, Aracytabin and Melphalan (BeEAM) as a preparative regimen for autologous stem cell transplantation in refractory/relapsed aggressive B-cell non-Hodgkin lymphoma patients.

    Primary: Complete remission rate

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    End point title
    		 Complete remission rate [1]
    End point description
    The primary endpoint of the study was to evaulate the 1-year complete remission (CR) rate.
    End point type
    Primary
    End point timeframe
    12 months (1 year).
    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 was a single arm study designed according to the Fleming's Method. OS and EFS was estimated according to Kaplan–Mayer method. The log rank test was used to assess the significance of differences for each prognostic factor in the univariate analysis. The Cox proportional hazards regression model and the logistic regression models was used to assess how patients’ characteristics predict EFS and OS.
    End point values
    		 Treatment arm
    Number of subjects analysed
    66
    Units: percentage
    82
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse event reporting was performed from April 1st, 2011 to February 22nd, 2021. Adverse events were notified to Mundipharma Pharmacovigilance office (producer of Bendamustine), to the following email EUDrugSafety@mundipharma-rd.eu
    Adverse event reporting additional description
    Please refer to Mundipharma Pharmacovigilance office for a detailed report on AE and SAE, because we do not have this information available.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    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: Adverse events were notified to Mundipharma Pharmacovigilance office (producer of Bendamustine), to the following email EUDrugSafety@mundipharma-rd.eu

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Oct 2020
    Due to a delay in the accrual of patients, related to the advent of CART cell therapies in this patient population, we decided to reduce the number of subjects by lowering the statystical power of the trial, in order to allow patients to receive CART instead of autologous stem cell transplantation, if available. According, we changed the statistycal analysis as follow: "Fixing the lowest acceptable rate as 55% and the successful rate as 70%, with a significance level alpha=0.05 and a power 1-beta =0.80, the sample size was estimated in 64 patients. Considering a possible drop-out rate of 3%, the number of patients entering the protocol is fixed to 66."

    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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