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    Clinical Trial Results:
    Ofatumumab in relapsed nodular lymphocyte predominant Hodgkin Lymphoma

    Summary
    EudraCT number
    		 2010-022180-35
    Trial protocol
    		 DE  
    Global end of trial date
    22 Apr 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Mar 2020
    First version publication date
    19 Mar 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Uni-Koeln-1432
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01187303
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Cologne
    Sponsor organisation address
    Albertus Magnus-Platz, Köln, Germany, 50923
    Public contact
    Trial Coordination Center of the German Hodgkin Study Group (GHSG), German Hodgkin Study Group (GHSG), 0049 22147888200, ghsg@uk-koeln.de
    Scientific contact
    Trial Coordination Center of the German Hodgkin Study Group (GHSG), German Hodgkin Study Group (GHSG), 0049 22147888200, ghsg@uk-koeln.de
    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
    09 Jun 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Apr 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary aim of the trial was to implement the fully human monoclonal anti-CD20 antibody ofatumumab into the treatment of patients with relapsed nodular lymphocyte predominant Hodgkin lymphoma (NLPHL), and to determine whether treatment with ofatumumab was likely to meet a basic level of efficacy in this setting.
    Protection of trial subjects
    Written informed consent prior to study entry; Weekly blood test during therapy; Premedication with acetaminophen , antihistamine and glucocorticoid before each ofatumumab infusion; Reduced infusion rate in case of AEs
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Jul 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Safety
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 28
    Worldwide total number of subjects
    28
    EEA total number of subjects
    28
    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)
    26
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between 05 July 2011 and 26 February 2014, 28 patients were recruited in one German trial site.

    Pre-assignment
    Screening details
    		 Main entry criteria were relapsed nodular lymphocyte predominant Hodgkin lymphoma (NLPHL), age 18-75 years, no anti-CD20 antibody treatment in the six months prior to enrollment. Main exclusion criteria were composite lymphoma, concurrent disease which precludes protocol treatment, pregnancy, lactation.

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

    Arms
    Arm title
    		 Intervention
    Arm description
    		 Intervention Group
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ofatumumab
    Investigational medicinal product code
    L01XC10
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The investigational medical product, ofatumumab, is a liquid concentrate for solution presented in glass vials. Ofatumumab will be infused intravenously at 300 mg in the first week, followed by seven weekly infusions at 1000 mg. In case of delay > 2 weeks the patient will be excluded from the trial. The ofatumumab infusions will be prepared by the pharmacy of the University Hospital Cologne in 1000 mL NaCl sterile, pyrogen free 0.9% NaCl to yield a 0.3 mg/mL and 1 mg/mL ofatumumab concentration for the first and subsequent infusions, respectively.

    Number of subjects in period 1
    		Intervention
    Started
    28
    Completed
    28

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Trial
    Reporting group description
    		 -

    Reporting group values
    		 Trial Total
    Number of subjects
    		 28 28
    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)
    		 0 0
        Adults (18-64 years)
    		 26 26
        From 65-84 years
    		 2 2
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 44.5 (22 to 68) -
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 18 18
    Subject analysis sets

    Subject analysis set title
    Primary endpoint analysis set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Patients who receive less than 4 infusions for reasons other than progressive disease or who discontinue treatment for other reasons than adverse events or who drop out before completion of the final restaging cannot be evaluated for the primary efficacy endpoint and will be replaced.

    Subject analysis sets values
    		 Primary endpoint analysis set
    Number of subjects
    28
    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)
    26
        From 65-84 years
    2
        85 years and over
    0
    Age continuous
    Units: years
        median (full range (min-max))
    44.5 (22 to 68)
    Gender categorical
    Units: Subjects
        Female
    10
        Male
    18

    End points

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    End points reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 Intervention Group

    Subject analysis set title
    Primary endpoint analysis set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Patients who receive less than 4 infusions for reasons other than progressive disease or who discontinue treatment for other reasons than adverse events or who drop out before completion of the final restaging cannot be evaluated for the primary efficacy endpoint and will be replaced.

    Primary: Objective Response Rate

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    End point title
    		 Objective Response Rate [1]
    End point description
    The objective response rate (ORR) is the proportion of patients showing an overall tumor response (CR, CRr, PR) at the CT-based restaging 3 months after completion of study treatment. The one-sided 95% confidence interval for the ORR ranged from 84.2% to 100% and thus excluded the predefined efficacy benchmark of 70%.
    End point type
    Primary
    End point timeframe
    3 months after 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: This is a single-arm study with no comparison. It is not possible to enter a single-arm analysis in the system. The primary statistical analysis was as follows. The null hypothesis H0 “ORR < 70%” was tested versus a one-sided alternative via a one-sided exact binomial 95% confidence interval. The respective confidence interval ranged from 84.2% to 100% and thus excluded the predefined efficacy benchmark.
    End point values
    		 Intervention Primary endpoint analysis set
    Number of subjects analysed
    28
    28
    Units: totals
        Objective response
    27
    27
        No objective response
    1
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    First application of study treatment until 28 days after last dose of study medication. After that, all AEs that are judged at least as possibly related to the treatment by the investigator, had to be documented until end of study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.1
    Reporting groups
    Reporting group title
    Safety set
    Reporting group description
    		 The safety set consists of all patients of the FAS who had at least one valid post-baseline safety assessment (as documented on the therapy CRF or on the AE CRF).

    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: Only AEs of CTCAE grade >=3 were to be recorded in this study. No non-serious AE of CTCAE grade >=3 has been reported.
    Serious adverse events
    		 Safety set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 28 (3.57%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Infections and infestations
    Myocarditis post infection
         subjects affected / exposed
    1 / 28 (3.57%)
         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
    		 Safety set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 28 (0.00%)

    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.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26585412
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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
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