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    Clinical Trial Results:
    BENEFIT - A multicenter phase II study evaluating BeEAM (Bendamustine, Etoposide, Cytarabine, Melphalan) prior to autologous stem cell transplant for first and second chemosensitive relapses in patients with follicular lymphoma

    Summary
    EudraCT number
    		 2013-000076-16
    Trial protocol
    		 FR  
    Global end of trial date
    08 Oct 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Mar 2021
    First version publication date
    17 Mar 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ET13-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02008006
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Centre Léon Bérard
    Sponsor organisation address
    28 rue Laennec, LYON, France, 69008
    Public contact
    DRCI, Centre Léon Bérard, 33 (0)478 78 28 28, DRCIreglementaire@lyon.unicancer.fr
    Scientific contact
    DRCI, Centre Léon Bérard, 33 (0)478 78 28 28, DRCIreglementaire@lyon.unicancer.fr
    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
    08 Nov 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Oct 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Oct 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to evaluate the efficacy of BeEAM (bendamustine, etoposide, cytarabine and melphalan) regimen prior to autologous stem cell transplant for first and second chemosensitive relapses in patients with follicular lymphoma (WHO grade 1, 2, 3a) by measuring the event-free survival define by relapse (for complete responders at the beginning of treatment), progression, death from any cause and initiation of a new therapy.
    Protection of trial subjects
    Patients achieving a complete or partial response after salvage treatment according to 2007 Cheson international response criteria and being eligible for transplant will proceed to the inclusion visit. The inclusion will be performed after salvage treatment before HDT. The investigator or designee staff will have to proceed to the following information/procedures during the inclusion visit: - Inform the patient of the treatments, the objectives and the design of the study, answer to questions and sign with him/her the informed consent form (ICF). The investigator must not start any study related procedure before ICF is signed and dated by both patient (or impartial witness, if applicable) and investigator - Check the eligibility criteria list Inclusion visit Patient registration Assessment during study treatment (BeEAM treatment) Hematological assessment post ASCT Day 100 assessment after ASCT Long-term follow up
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Jun 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
    France: 21
    Worldwide total number of subjects
    21
    EEA total number of subjects
    21
    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)
    21
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 First and second chemosensitive relapses in patients with WHO grade 1, 2 and 3a follicular lymphoma Adult patients aged from 18 to 65 years with previously treated follicular lymphoma (WHO grade 1, 2, 3a) without contraindication to autologous stem cell transplantation (ASCT) in first and second chemosensitive relapses

    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
    		 Experimental
    Arm description
    		 The proposed trial is a single arm, multicenter, open-label, phase II study. Patients will be pre-treated with a salvage treatment. Then, patients will be consolidated by BeEAM regiment prior to ASCT: - Bendamustine (160 mg/m² from day -8 to-7) - Etoposide (200 mg/m² from day -6 to day -3: 100mg/m2 every 12h) - Cytarabine (400 mg/m² from day -6 to day -3: 200 mg/m2 every 12h) - Melphalan (140 mg/m² on day -2) ASCT will be performed according to standard recommendations. After ASCT, administration of any other chemotherapy agents or regimen is not allowed. During the study, 9 visits will be performed after ASCT during 4 years: - At D100 and M6, - Then every 6 months (M12, M18, M24, M30, M36, M42 and M48)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bendamustine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Rutiximab- based salvage treatment and mobilization procedure before ASCT Conditioning regimen: BeEAM Patients will be consolidated by BeEAM regimen prior to ASCT: - Bendamustine (160 mg/m² from day -8 and -7) - Etoposide (200 mg/m² from day -6 to day -3) - Cytarabine (400 mg/m² from day -6 to day -3) - Melphalan (140 mg/m² on day -2) ASCT Management after ASCT

    Number of subjects in period 1 [1]
    		Experimental
    Started
    20
    Completed
    20
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: One patient was enrolled before the inclusions were suspended and he did not receive the study treatment. The analysis population consists of the 20 patients treated.

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Experimental
    Reporting group description
    		 The proposed trial is a single arm, multicenter, open-label, phase II study. Patients will be pre-treated with a salvage treatment. Then, patients will be consolidated by BeEAM regiment prior to ASCT: - Bendamustine (160 mg/m² from day -8 to-7) - Etoposide (200 mg/m² from day -6 to day -3: 100mg/m2 every 12h) - Cytarabine (400 mg/m² from day -6 to day -3: 200 mg/m2 every 12h) - Melphalan (140 mg/m² on day -2) ASCT will be performed according to standard recommendations. After ASCT, administration of any other chemotherapy agents or regimen is not allowed. During the study, 9 visits will be performed after ASCT during 4 years: - At D100 and M6, - Then every 6 months (M12, M18, M24, M30, M36, M42 and M48)

    Primary: Primary end point

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    End point title
    		 Primary end point [1]
    End point description
    End point type
    Primary
    End point timeframe
    Event-free survival define by relapse (for complete responders at the beginning of treatment), progression, death from any cause and initiation of a new therapy
    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: Qualitative variables will be described using frequency and percentage distributions. Quantitative data will be described using the number of observations, mean, standard deviation, median, minimum and maximum values, and the number of missing data if appropriate. Patient characteristics and other baseline data will be summarized. The date of inclusion (beginning of BeEAM regimen) will serve as a reference for calculation of durations unless otherwise indicated.
    End point values
    		 Experimental
    Number of subjects analysed
    20
    Units: month
    20
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    The investigator collects (spontaneous patient report or questionning) and immediately notifies the sponsor of all SAEs, in a written report, wether or not theay are deemed to be attributable to research and wich occur during the study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    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: All 20 patients treated experienced one or more adverse events. For the 20 patients at least one of the events was related to the study treatment and all also had at least one grade> = 3 AE. 16 patients reported at least one SAE during the study including 3 patients with two SAEs, 2 patients with 4 SAEs and one patient with 5 SAEs, for a total of 29 SAEs.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Jul 2015
    Extend the duration of inclusions by one year
    03 Nov 2015
    Response to the ANSM's request dated 09/08/2015 to amend the protocol (criteria for non-inclusion) following the occurrence of 2 cases of veno-occlusive disease related to the treatment and our declaration of a new fact of security of 08/05/2015 Addition of three exclusion criteria: History of chronic liver disease, excessive alcohol consumption and History of veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS)
    15 Apr 2016
    Temporary stop of the trial and establishment of an independent monitoring committee
    19 Sep 2016
    Resumption after temporary stop of the trial and modification requested by the independent monitoring committee
    12 Dec 2017
    Recruitment was temporarily interrupted on 09/25/17 due to poor recruitment in this study (21 patients included out of the 50 expected) and the expiration of the treatment units on 09/30/17.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    24 Nov 2017
    A monitoring committee was held on 04/18/2016 (19 patients included including 18 treated) following the occurrence of the 2 new safety facts. This committee recommended "Temporary stopping of recruitment pending the collection of additional information" (the Promoter had already suspended inclusions since 02/12/2016). On June 16, 2016 the committee met again and it was decided to continue the test with amendment. The final discontinuation of the study was decided on 24/11/2017 before reaching the number of patients provided for in the protocol.
    -

    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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