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    Clinical Trial Results:
    Consolidation Therapy with Brentuximab Vedotin after Allogeneic Stem Cell Transplantation for Relapsed or Refractory Hodgkin Lymphoma

    Summary
    EudraCT number
    		 2018-000873-59
    Trial protocol
    		 DE  
    Global end of trial date
    12 Sep 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Oct 2025
    First version publication date
    23 Oct 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Uni-Koeln-3263
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03652441
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Cologne
    Sponsor organisation address
    Albertus-Magnus-Platz, Cologne, Germany, 50923
    Public contact
    Trial Coordination Center, German Hodgkin Study Group (GHSG), 0049 22147888200, ghsg@uk-koeln.de
    Scientific contact
    Trial Coordination Center, 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
    10 Jan 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Sep 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Sep 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The aim of the trial is to improve disease control after an allogeneic stem cell transplantation (alloSCT) for relapsed or refractory classical Hodgkin lymphoma (rrHL, cHL) with consolidation therapy by Brentuximab Vedotin (BV) for up to one year.
    Protection of trial subjects
    Participants give their written informed consent to partcipate in the trial. They may discontinue trial treatment at their own wish at any time. Protocol treatment can be terminated by the treating physician due to unacceptable toxicity, progressive disease (PD), serious concurrent disease or pregnancy. The trial can be terminated early by the trial chairman if the safety of the trial participants appears to be at risk. The BV-ALLO trial is terminated completely if there is a considerable change in the risk-benefit-ratio for patients, the sponsor considers a termination to be necessary for safety reasons (protocol section 9.6.3), it is no longer justifiable to use trial medication or the trial proves to be not feasible.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Nov 2019
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 4 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 13
    Worldwide total number of subjects
    13
    EEA total number of subjects
    13
    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)
    13
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial aimed to enroll 21 patients over approximately 2 years with 19 patients being eligible. A total of 13 patients were enrolled before the trail was prematurely closed due to feasibility in light of slow recruitment.

    Pre-assignment
    Screening details
    		 One participant had a screening failure and could not be included in the trial.

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

    Arms
    Arm title
    		 Single-arm
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Brentuximab Vedotin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Infusion , Intravenous use
    Dosage and administration details
    BV was administered over 30 minutes every 3 weeks at a dose of 1.8 mg/kg body weight intravenously for up to 16 infusions or until day +365 after alloSCT.

    Number of subjects in period 1
    		Single-arm
    Started
    13
    Completed
    13

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial - Treatment and Follow-up
    Reporting group description
    		 The reporting group consists of alle patients evaluated in the final analysis. This corresponds to the Full Analysis Set (FAS), which includes all patients who qualified for enrollment and received at least one dose of Brentuximab Vedotin.

    Reporting group values
    		 Overall trial - Treatment and Follow-up Total
    Number of subjects
    		 13 13
    Age categorical
    Units: Subjects
        18-19
    		 1 1
        20-29
    		 4 4
        30-39
    		 3 3
        40-49
    		 3 3
        50-59
    		 1 1
        60-69
    		 0 0
        >70
    		 1 1
    Age continuous
    Patients had to be 18 years or older
    Units: years
        median (full range (min-max))
    		 33 (19 to 61) -
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 9 9
    Performance Status (ECOG)
    Units: Subjects
        ECOG 0
    		 3 3
        ECOG 1
    		 10 10
    Stage (I-IV)
    Units: Subjects
        Stage I
    		 0 0
        Stage II
    		 1 1
        Stage III
    		 3 3
        Stage IV
    		 6 6
        not reported
    		 3 3
    International Prognostic Score (IPS)
    The prognostic score was defined as the number of adverse prognostic factors present at diagnosis. Defined as a serum albumin level of less than 4 g per deciliter, a hemoglobin level of less than 10.5 g per deciliter, male sex, an age of 45 years or older, stage IV disease (according to the Ann Arbor classification), leukocytosis (a white-cell count of at least 15,000 per cubic millimeter), and lymphocytopenia (a lymphocyte count of less than 600 per cubic millimeter, a count that was less than 8 percent of the white-cell count, or both)
    Units: Subjects
        IPS 1
    		 1 1
        IPS 2
    		 2 2
        IPS 3
    		 3 3
        IPS 4
    		 2 2
        IPS 5
    		 0 0
        IPS 6
    		 1 1
        not recorded
    		 4 4
    B-Symptoms
    Units: Subjects
        Yes
    		 6 6
        No
    		 1 1
        not recorded
    		 6 6
    Ann-Arbor Stage of last relapse
    Only relapsed/refractory cHL patients who receive allogeneic stem cell transplantation were included in the trial.
    Units: Subjects
        IA
    		 0 0
        IB
    		 0 0
        IIA
    		 1 1
        IIB
    		 0 0
        IIIA
    		 1 1
        IIIB
    		 1 1
        IVA
    		 4 4
        IVB
    		 0 0
        Not recorded
    		 6 6
    Body height
    Units: cm
        median (full range (min-max))
    		 177 (155 to 186) -
    Body weight
    Units: kg
        median (full range (min-max))
    		 70 (47 to 130) -
    Body Mass Index (BMI)
    Units: numbers
        median (full range (min-max))
    		 23.3 (18.1 to 37.6) -
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FAS consists of all patients who received at least one dose of Brentuximab Vedotin (BV).

    Subject analysis set title
    Efficacy Analysis Set (EAS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The efficacy analysis set (EAS) consists of all FAS patients who are evaluable for the primary efficacy endpoint.

    Subject analysis set title
    Efficacy Analysis Set (EAS) Dummy
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    A dublicate analysis set was created only to satisfy the EudraCT system requirement for at least two comparison groups. Both sets contain the same 10 patients.

    Subject analysis sets values
    		 Full Analysis Set (FAS) Efficacy Analysis Set (EAS) Efficacy Analysis Set (EAS) Dummy
    Number of subjects
    13
    10
    10
    Age categorical
    Units: Subjects
        18-19
    1
    0
    0
        20-29
    4
    4
    4
        30-39
    3
    3
    3
        40-49
    3
    1
    1
        50-59
    1
    1
    1
        60-69
    0
    0
    0
        >70
    1
    1
    1
    Age continuous
    Patients had to be 18 years or older
    Units: years
        median (full range (min-max))
    33 (19 to 61)
    33 (20 to 61)
    33 (20 to 61)
    Gender categorical
    Units: Subjects
        Female
    4
    2
    2
        Male
    9
    8
    8
    Performance Status (ECOG)
    Units: Subjects
        ECOG 0
    3
    1
    1
        ECOG 1
    10
    9
    9
    Stage (I-IV)
    Units: Subjects
        Stage I
    0
    0
    0
        Stage II
    1
    1
    1
        Stage III
    3
    3
    3
        Stage IV
    6
    6
    6
        not reported
    3
    0
    0
    International Prognostic Score (IPS)
    The prognostic score was defined as the number of adverse prognostic factors present at diagnosis. Defined as a serum albumin level of less than 4 g per deciliter, a hemoglobin level of less than 10.5 g per deciliter, male sex, an age of 45 years or older, stage IV disease (according to the Ann Arbor classification), leukocytosis (a white-cell count of at least 15,000 per cubic millimeter), and lymphocytopenia (a lymphocyte count of less than 600 per cubic millimeter, a count that was less than 8 percent of the white-cell count, or both)
    Units: Subjects
        IPS 1
    1
    1
    1
        IPS 2
    2
    2
    2
        IPS 3
    3
    3
    3
        IPS 4
    2
    2
    2
        IPS 5
    0
    0
    0
        IPS 6
    1
    1
    1
        not recorded
    4
    1
    1
    B-Symptoms
    Units: Subjects
        Yes
    6
    6
    6
        No
    1
    1
    1
        not recorded
    6
    3
    3
    Ann-Arbor Stage of last relapse
    Only relapsed/refractory cHL patients who receive allogeneic stem cell transplantation were included in the trial.
    Units: Subjects
        IA
    0
    0
    0
        IB
    0
    0
    0
        IIA
    1
    1
    1
        IIB
    0
    0
    0
        IIIA
    1
    1
    1
        IIIB
    1
    1
    1
        IVA
    4
    4
    4
        IVB
    0
    0
    0
        Not recorded
    6
    3
    3
    Body height
    Units: cm
        median (full range (min-max))
    177 (155 to 186)
    181.5 (156 to 186)
    181.5 (156 to 186)
    Body weight
    Units: kg
        median (full range (min-max))
    70 (47 to 130)
    71.5 (56 to 130)
    71.5 (56 to 130)
    Body Mass Index (BMI)
    Units: numbers
        median (full range (min-max))
    23.3 (18.1 to 37.6)
    24.2 (18.1 to 37.6)
    24.2 (18.1 to 37.6)

    End points

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    End points reporting groups
    Reporting group title
    Single-arm
    Reporting group description
    		 -

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FAS consists of all patients who received at least one dose of Brentuximab Vedotin (BV).

    Subject analysis set title
    Efficacy Analysis Set (EAS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The efficacy analysis set (EAS) consists of all FAS patients who are evaluable for the primary efficacy endpoint.

    Subject analysis set title
    Efficacy Analysis Set (EAS) Dummy
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    A dublicate analysis set was created only to satisfy the EudraCT system requirement for at least two comparison groups. Both sets contain the same 10 patients.

    Primary: Cumulative Incidence of Relapse (CIR)

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    End point title
    		 Cumulative Incidence of Relapse (CIR)
    End point description
    The tumor status was determined at the final restging (RE-365).
    End point type
    Primary
    End point timeframe
    Efficacy was determined using the CIR within the first year after aSCT.
    End point values
    		 Efficacy Analysis Set (EAS) Efficacy Analysis Set (EAS) Dummy
    Number of subjects analysed
    10
    10
    Units: percent
        number (confidence interval 95%)
    50 (18.7 to 81.3)
    50 (18.7 to 81.3)
    Statistical analysis title
    		 Primary endpoint analysis: 12-month CIR
    Statistical analysis description
    The statistical analysis originally planned in the trial protocol was not done due to insufficient patient numbers for the test. Instead, an exact one-sided 95% confidence interval for the CIR was calculated for the enpoint. A dublicate analysis set was created just to satisfy technical requirements; both sets contain the same 10 patients.
    Comparison groups
    Efficacy Analysis Set (EAS) v Efficacy Analysis Set (EAS) Dummy
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 12-month Cumulative Incidence of Relapse
    Point estimate
    50
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 18.7
         upper limit
    		 81.3

    Secondary: Progression-free survival (PFS)

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    End point title
    		 Progression-free survival (PFS)
    End point description
    PFS was calculated as time between the date of aSCT and the date of first progression, realpase or death or, in case of continuing response, the date of the last documented follow-up. Patients were censored at the date of the last documented follow-up if no progression/relapse or death was registered before the trial end.
    End point type
    Secondary
    End point timeframe
    1-year progression-free survival will be reported
    End point values
    		 Single-arm Full Analysis Set (FAS)
    Number of subjects analysed
    13
    13
    Units: percentage
        number (confidence interval 95%)
    76.9 (54 to 99.8)
    76.9 (54 to 99.8)
    No statistical analyses for this end point

    Secondary: Overall survival (OS)

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    End point title
    		 Overall survival (OS)
    End point description
    Overall survival was calculated as time between the date of aSCT and the date of death or the date of last documented follow-up. Patients were censored at the date of last documented follow-up if no death was registered befor trial end.
    End point type
    Secondary
    End point timeframe
    1-year overall surival will be reported.
    End point values
    		 Single-arm Full Analysis Set (FAS)
    Number of subjects analysed
    13
    13
    Units: percentage
        number (confidence interval 95%)
    76.9 (54 to 99.8)
    76.9 (54 to 99.8)
    No statistical analyses for this end point

    Secondary: Remission status (RE-100)

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    End point title
    		 Remission status (RE-100)
    End point description
    In case, BV treatment ended before RE-365 and no data of end of treatment restaging was available, the last documented restaging was used.
    End point type
    Secondary
    End point timeframe
    Remission status (CR, PR, NC, PD) was summarized at the end of the BV treatment (RE-365).
    End point values
    		 Single-arm Full Analysis Set (FAS)
    Number of subjects analysed
    13
    Units: subjects
        Complete remission (CR)
    10
    10
        Partial remission (PR)
    0
    0
        No change (NC)
    0
    0
        Progressive disease (PD)
    2
    1
        RE not done
    1
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All events up to 30 days after end of treatment (EOT) had to be reported. Events that occured later than 30 days after EOT had to be reported if causality was rated as at least "possible".
    Adverse event reporting additional description
    AEs were assessed on therapy administration CRFs. SAEs were additionally assessed on specific forms. SAEs may thus be reported twice; non-serious AEs might contain SAEs; non-serious and SAEs might not add up to a total number of AEs. All AEs of CTCAE grade >=1 were reported.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.1
    Reporting groups
    Reporting group title
    Single-arm
    Reporting group description
    		 -

    Serious adverse events
    		 Single-arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 13 (69.23%)
         number of deaths (all causes)
    3
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Urinary bladder adenoma
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal ulcer
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Cystitis
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
    Additional description: Patient had a lung infection (fungal pneumonia) after allogeneic stem cell transplantation. The event is not related to treatment with BV.
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
    Additional description: 1 patient had a sepsis with fulminant development of pneumonia with palliative procedure at patient's request. . 1 patient had a sepsis due to phlegmon left upper thigh (Myositis). In both cases, sepsis was possibly related to allogeneic SCT.
         subjects affected / exposed
    2 / 13 (15.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Streptococcal infection
         subjects affected / exposed
    1 / 13 (7.69%)
         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
    		 Single-arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 13 (100.00%)
    Nervous system disorders
    Sensory polyneuropathy
         subjects affected / exposed
    10 / 13 (76.92%)
         occurrences all number
    10
    General disorders and administration site conditions
    Alopecia
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    2
    Anaphylactic reaction
         subjects affected / exposed
    2 / 13 (15.38%)
         occurrences all number
    2
    Bleeding
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Impairment of organ function
         subjects affected / exposed
    5 / 13 (38.46%)
         occurrences all number
    5
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    9 / 13 (69.23%)
         occurrences all number
    38
    Febrile neutropenia
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    haemorrhagic cystitis
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    2
    Leukopenia
         subjects affected / exposed
    8 / 13 (61.54%)
         occurrences all number
    24
    Neutropenia
         subjects affected / exposed
    8 / 13 (61.54%)
         occurrences all number
    18
    Thrombocytopenia
         subjects affected / exposed
    8 / 13 (61.54%)
         occurrences all number
    28
    Gastrointestinal disorders
    Gastrointestinal disorder
         subjects affected / exposed
    4 / 13 (30.77%)
         occurrences all number
    7
    Mucositis
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Nausea / vomiting
         subjects affected / exposed
    7 / 13 (53.85%)
         occurrences all number
    13
    Hepatobiliary disorders
    Hepatobiliary disorder
         subjects affected / exposed
    6 / 13 (46.15%)
         occurrences all number
    10
    Infections and infestations
    Infection
         subjects affected / exposed
    7 / 13 (53.85%)
         occurrences all number
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Jul 2020
    Update of SmPC
    16 Jun 2021
    Update of SmPC
    26 Oct 2021
    Update of SmPC

    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.
    The recruitment of the BV-Allo trial was prematurely closed on 31.08.2022 due to feasibility in light of slow recruitment. Therefore, the planned statistical analyses were not done.
    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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