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    Clinical Trial Results:
    A phase II study evaluating the effect of the addition of lenalidomide to R-CHOP for patients with newly diagnosed MYC positive DLBCL and BCL-U

    Summary
    EudraCT number
    		 2014-002654-39
    Trial protocol
    		 NL   BE  
    Global end of trial date
    21 Dec 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Dec 2022
    First version publication date
    17 Dec 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HO130
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    HOVON
    Sponsor organisation address
    De Boelelaan 1117, Amsterdam, Netherlands,
    Public contact
    HOVON Data Center, HOVON, +31 0107041560, hdc@erasmusmc.nl
    Scientific contact
    HOVON Data Center, HOVON, +31 0107041560, hdc@erasmusmc.nl
    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
    26 Sep 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Jun 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Dec 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of the combination of lenalidomide and R-CHOP in MYC+ DLBCL patients in terms of CR rate by end-of-treatment 18F-FDG PET-CT scan and BM.
    Protection of trial subjects
    Monitoring and Insurance
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Feb 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
    Netherlands: 83
    Country: Number of subjects enrolled
    Belgium: 2
    Worldwide total number of subjects
    85
    EEA total number of subjects
    85
    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)
    1
    Adults (18-64 years)
    45
    From 65 to 84 years
    39
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 All subjects gave written informed consent and were screened according to the inclusion- and exclusion criteria

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

    Arms
    Arm title
    		 Experimental Group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lenalidomide
    Investigational medicinal product code
    Other name
    Revlimib
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    15mg, day 1 - 14.

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    750mg/m2 on day 1.

    Investigational medicinal product name
    Vincristine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    1.4 mg/m2 (max 2mg) on day 1

    Investigational medicinal product name
    Doxorubicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    50mg/m2 on day 1

    Investigational medicinal product name
    Rituximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    375 mg/m2 on day 1

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100mg on day 1-5

    Investigational medicinal product name
    Pegfilgrastim
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    6mg on day 2

    Number of subjects in period 1
    		Experimental Group
    Started
    85
    Completed
    72
    Not completed
    13
         Adverse reactions
    2
         Other
    3
         At patient's request
    1
         Lack of efficacy
    7

    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
    		 85 85
    Age categorical
    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)
    		 1 1
        Adults (18-64 years)
    		 45 45
        From 65-84 years
    		 39 39
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 63 (29 to 82) -
    Gender categorical
    Units: Subjects
        Female
    		 27 27
        Male
    		 58 58

    End points

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    End points reporting groups
    Reporting group title
    Experimental Group
    Reporting group description
    		 -

    Primary: Primary Endpoint

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    End point title
    		 Primary Endpoint [1]
    End point description
    End point type
    Primary
    End point timeframe
    See publication.
    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: See attached chart/documents for results.
    End point values
    		 Experimental Group
    Number of subjects analysed
    82
    Units: Whole
    82
    Attachments
    		 Statistical data section from publication
    List of reported non-SAE's
    List of reported SAE's
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events will be reported from the first study-related procedure until 30 days following the last dose of any drug from the protocol treatment schedule or until the start of subsequent systemic therapy for the disease under study, if earlier.
    Adverse event reporting additional description
    Adverse events occurring after 30 days should also be reported if considered at least possibly related to the investigational medicinal product by the investigator.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4
    Reporting groups
    Reporting group title
    Experimental Group
    Reporting group description
    		 -

    Serious adverse events
    		 Experimental Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    37 / 85 (43.53%)
         number of deaths (all causes)
    29
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    7 / 85 (8.24%)
         occurrences causally related to treatment / all
    4 / 7
         deaths causally related to treatment / all
    1 / 1
    Vascular disorders
    Vascular disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Surgical and medical procedures
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    General disorders and administration site conditions
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    8 / 85 (9.41%)
         occurrences causally related to treatment / all
    5 / 9
         deaths causally related to treatment / all
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Respiratory, thoracic and mediastinal disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    2 / 85 (2.35%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Investigations
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Injury, poisoning and procedural complications
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Cardiac disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    4 / 85 (4.71%)
         occurrences causally related to treatment / all
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Nervous system disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    4 / 85 (4.71%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Blood and lymphatic system disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    8 / 85 (9.41%)
         occurrences causally related to treatment / all
    9 / 9
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    11 / 85 (12.94%)
         occurrences causally related to treatment / all
    8 / 14
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Renal and urinary disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    2 / 85 (2.35%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal and connective tissue disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Infections and infestations
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    12 / 85 (14.12%)
         occurrences causally related to treatment / all
    13 / 16
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Metabolism and nutrition disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Experimental Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    71 / 85 (83.53%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    1 / 85 (1.18%)
         occurrences all number
    1
    Vascular disorders
    Vascular disorders
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    10 / 85 (11.76%)
         occurrences all number
    13
    Surgical and medical procedures
    Surgical and medical procedures
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    1 / 85 (1.18%)
         occurrences all number
    1
    General disorders and administration site conditions
    General disorders and administration site conditions
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    10 / 85 (11.76%)
         occurrences all number
    16
    Reproductive system and breast disorders
    Reproductive system and breast disorders
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    1 / 85 (1.18%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Respiratory, thoracic and mediastinal disorders
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    8 / 85 (9.41%)
         occurrences all number
    9
    Psychiatric disorders
    Psychiatric disorders
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    1 / 85 (1.18%)
         occurrences all number
    1
    Investigations
    Investigations
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    20 / 85 (23.53%)
         occurrences all number
    63
    Cardiac disorders
    Cardiac disorders
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    7 / 85 (8.24%)
         occurrences all number
    8
    Nervous system disorders
    Nervous system disorders
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    33 / 85 (38.82%)
         occurrences all number
    38
    Blood and lymphatic system disorders
    Blood and lymphatic system disorders
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    11 / 85 (12.94%)
         occurrences all number
    19
    Ear and labyrinth disorders
    Ear and labyrinth disorders
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    5 / 85 (5.88%)
         occurrences all number
    5
    Eye disorders
    Eye disorders
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    3 / 85 (3.53%)
         occurrences all number
    3
    Gastrointestinal disorders
    Gastrointestinal disorders
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    24 / 85 (28.24%)
         occurrences all number
    33
    Hepatobiliary disorders
    Hepatobiliary disorders
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    1 / 85 (1.18%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Skin and subcutaneous tissue disorders
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    6 / 85 (7.06%)
         occurrences all number
    6
    Renal and urinary disorders
    Renal and urinary disorders
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    5 / 85 (5.88%)
         occurrences all number
    5
    Musculoskeletal and connective tissue disorders
    Musculoskeletal and connective tissue disorders
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    8 / 85 (9.41%)
         occurrences all number
    10
    Infections and infestations
    Infections and infestations
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    24 / 85 (28.24%)
         occurrences all number
    32
    Metabolism and nutrition disorders
    Metabolism and nutrition disorders
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    10 / 85 (11.76%)
         occurrences all number
    13

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Jun 2015
    Clarification in sections 9 and 10 in the protocol.
    17 Aug 2016
    Updates in section 4 and clarifications in section 8, 10 and 17 of the protocol.
    18 Jul 2017
    Target number of patients has been increased. Updates in section 4, 5, 6, clarifications in section 8, 9 , 10 and updates in section 14, 19 appendix B1 and B2.

    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
    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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