Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A pivotal study of SGN-35 in treatment of patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL)

    Summary
    EudraCT number
    		 2008-006035-12
    Trial protocol
    		 BE   DE   IT   FR   GB  
    Global end of trial date
    06 Jun 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Jan 2017
    First version publication date
    05 Jan 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    SG035-0004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00866047
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Seattle Genetics, Inc.
    Sponsor organisation address
    21823 30th Drive SE, Bothell, United States, 98021
    Public contact
    Chief Medical Officer, Seattle Genetics, Inc. , 1 855 473-2436, medinfo@seagen.com
    Scientific contact
    Chief Medical Officer, Seattle Genetics, Inc. , 1 855 473-2436, medinfo@seagen.com
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Oct 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Aug 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jun 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the antitumor efficacy of single-agent SGN-35 (1.8 mg/kg administered intravenously every 3 weeks) as measured by the overall objective response rate in patients with relapsed or refractory systemic anaplastic large cell lymphoma following front-line chemotherapy (CHOP or equivalent)
    Protection of trial subjects
    The protocol for this study was designed in accordance with the general ethical principles outlined in the Declaration of Helsinki. The conduct of all aspects of the study, including methods for obtaining informed consent, were also in accordance with principles enunciated in the declaration, the International Conference on Harmonisation (ICH) Good Clinical Practices (GCP), and applicable Food and Drug Administration (FDA) regulations/guidelines set forth in Title 21 CFR Parts 11, 50, 54, 56, and 312. The consent form approved by each IRB/IEC included all elements required by the applicable regional laws and regulations, including a statement that Seattle Genetics, Inc. and authorities had access to patient records. Consent was obtained from all patients before any protocol-required procedures were performed, including any procedure not part of normal patient care.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Mar 2009
    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
    United Kingdom: 3
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    France: 8
    Country: Number of subjects enrolled
    Canada: 3
    Country: Number of subjects enrolled
    United States: 43
    Worldwide total number of subjects
    58
    EEA total number of subjects
    12
    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)
    4
    Adults (18-64 years)
    45
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Enrollment period: March 2009 - May 2010

    Pre-assignment
    Screening details
    		 Patients with relapsed or refractory systemic ALCL who have previously received front line chemotherapy.

    Period 1
    Period 1 title
    Treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Brentuximab vedotin
    Arm description
    		 Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
    Arm type
    		 Experimental

    Investigational medicinal product name
    Brentuximab vedotin
    Investigational medicinal product code
    Other name
    ADCETRIS, SGN-35
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion

    Number of subjects in period 1
    		Brentuximab vedotin
    Started
    58
    Completed
    10
    Not completed
    48
         Adverse event, serious fatal
    6
         Physician decision
    14
         Patient decision
    5
         Adverse event, non-fatal
    10
         Progressive disease
    13

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 -

    Reporting group values
    		 Treatment Total
    Number of subjects
    		 58 58
    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)
    		 4 4
        Adults (18-64 years)
    		 45 45
        From 65-84 years
    		 9 9
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 52 (14 to 76) -
    Gender categorical
    Units: Subjects
        Female
    		 25 25
        Male
    		 33 33
    Race
    Units: Subjects
        Asian
    		 1 1
        Black or African American
    		 7 7
        White
    		 48 48
        Other
    		 2 2
    Eastern Cooperative Oncology Group Performance Status
    0 = Normal activity 1 = Symptoms but ambulatory 2 = In bed <50% of the time 3 = In bed >50% of the time 4 = 100% bedridden 5 = Dead
    Units: Subjects
        Zero
    		 19 19
        One
    		 38 38
        Two to Five
    		 1 1
    ALK Status
    Units: Subjects
        Positive
    		 16 16
        Negative
    		 42 42

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Brentuximab vedotin
    Reporting group description
    		 Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion

    Primary: Objective Response Rate by Independent Review Group

    		 Close Top of page
    End point title
    		 Objective Response Rate by Independent Review Group [1]
    End point description
    Percentage of participants who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
    End point type
    Primary
    End point timeframe
    Up to 12 months
    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: The primary efficacy hypothesis was specified. H0: ORR <20% versus Ha: ORR ≥20%
    End point values
    		 Brentuximab vedotin
    Number of subjects analysed
    58 [2]
    Units: Percent of Participants
    number (confidence interval 95%)
        ORR by Independent Review Group
    86 (74.6 to 93.9)
    Notes
    [2] - The primary efficacy hypothesis was specified. H0: ORR <20% versus Ha: ORR ≥20%
    No statistical analyses for this end point

    Secondary: Complete Remission Rate by Independent Review Group

    		 Close Top of page
    End point title
    		 Complete Remission Rate by Independent Review Group
    End point description
    Percentage of participants who achieved a best response of CR (disappearance of all evidence of disease) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma
    End point type
    Secondary
    End point timeframe
    up to 12 months
    End point values
    		 Brentuximab vedotin
    Number of subjects analysed
    58 [3]
    Units: Percent of Participants
    number (confidence interval 95%)
        CR Rate by Independent Review Group
    59 (44.9 to 71.4)
    Notes
    [3] - Intention to treat
    No statistical analyses for this end point

    Secondary: Duration of Objective Response by Kaplan-Meier Analysis

    		 Close Top of page
    End point title
    		 Duration of Objective Response by Kaplan-Meier Analysis
    End point description
    Duration of objective response (CR + PR) by independent review group, defined as time of initial response until disease progression or death
    End point type
    Secondary
    End point timeframe
    up to approximately 4 years
    End point values
    		 Brentuximab vedotin
    Number of subjects analysed
    50 [4]
    Units: Months
    number (confidence interval 95%)
        Duration of OR by Kaplan-Meier Analysis
    13.2 (5.7 to 26.3)
    Notes
    [4] - Participants with objective response among the intention to treat population
    No statistical analyses for this end point

    Secondary: Duration of Objective Response in Participants with Complete Remission by Kaplan-Meier Analysis

    		 Close Top of page
    End point title
    		 Duration of Objective Response in Participants with Complete Remission by Kaplan-Meier Analysis
    End point description
    Duration of response from start of first objective tumor response (CR or PR) by independent review group to disease progression or death due to any cause in participants with CR
    End point type
    Secondary
    End point timeframe
    up to approximately 4 years
    End point values
    		 Brentuximab vedotin
    Number of subjects analysed
    34 [5]
    Units: Months
    number (confidence interval 95%)
        Duration of OR in Participants with CR
    26.3 (13.2 to 999)
    Notes
    [5] - Participants w/CR (ITT population) 999 = NA; insufficient number of events to estimate upper bound
    No statistical analyses for this end point

    Secondary: Progression-free Survival by Kaplan-Meier Analysis

    		 Close Top of page
    End point title
    		 Progression-free Survival by Kaplan-Meier Analysis
    End point description
    Time from start of study treatment to disease progression per independent review group or death due to any cause
    End point type
    Secondary
    End point timeframe
    up to approximately 4 years
    End point values
    		 Brentuximab vedotin
    Number of subjects analysed
    58
    Units: Months
    number (confidence interval 95%)
        Progression-free Survival by Kaplan-Meier Analysis
    14.6 (6.9 to 20.6)
    No statistical analyses for this end point

    Secondary: Overall Survival

    		 Close Top of page
    End point title
    		 Overall Survival
    End point description
    Time from start of study treatment to date of death due to any cause
    End point type
    Secondary
    End point timeframe
    up to approximately 7 years
    End point values
    		 Brentuximab vedotin
    Number of subjects analysed
    58 [6]
    Units: Months
    number (confidence interval 95%)
        Overall Survival
    999 (21.3 to 999)
    Notes
    [6] - Intention to treat 999 = NA; insufficient number of events to estimate
    No statistical analyses for this end point

    Secondary: Adverse Events by Severity, Seriousness, and Relationship to Treatment

    		 Close Top of page
    End point title
    		 Adverse Events by Severity, Seriousness, and Relationship to Treatment
    End point description
    Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.
    End point type
    Secondary
    End point timeframe
    up to 12 months
    End point values
    		 Brentuximab vedotin
    Number of subjects analysed
    58 [7]
    Units: Participants
    number (not applicable)
        Any TEAE
    58
        TEAE related to study drug
    53
        TEAE with severity grade >/=3
    36
        Serious adverse event
    25
        Serious adverse event related to study drug
    11
        Discontinued treatment due to adverse event
    16
    Notes
    [7] - All participants who received treatment
    No statistical analyses for this end point

    Secondary: Hematology Laboratory Abnormalities >/= Grade 3

    		 Close Top of page
    End point title
    		 Hematology Laboratory Abnormalities >/= Grade 3
    End point description
    Counts of study participants with pose-baseline hematology laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.
    End point type
    Secondary
    End point timeframe
    up to 12 months
    End point values
    		 Brentuximab vedotin
    Number of subjects analysed
    58 [8]
    Units: Participants
    number (not applicable)
        Any >/= Grade 3 hematology laboratory abnormality
    17
        Leukocytes (low)
    3
        Lymphocytes (low)
    10
        Neutrophils (low)
    7
        Platelets (low)
    3
    Notes
    [8] - All participants who received treatment
    No statistical analyses for this end point

    Secondary: Chemistry Laboratory Abnormalities >/= Grade 3

    		 Close Top of page
    End point title
    		 Chemistry Laboratory Abnormalities >/= Grade 3
    End point description
    Counts of study participants with post-baseline chemistry laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.
    End point type
    Secondary
    End point timeframe
    up to 12 months
    End point values
    		 Brentuximab vedotin
    Number of subjects analysed
    58 [9]
    Units: Participants
    number (not applicable)
        Any >/= Grade 3 chemistry laboratory abnormality
    13
        Aspartate Aminotransferase (High)
    1
        Calcium (Low)
    3
        Glucose (High)
    4
        Potassium (Low)
    1
        Sodium (Low)
    1
        Urate (High)
    3
    Notes
    [9] - All participants who received treatment
    No statistical analyses for this end point

    Other pre-specified: B Symptom Resolution

    		 Close Top of page
    End point title
    		 B Symptom Resolution
    End point description
    Percentage of participants with lymphoma-related symptoms (B symptoms: fever, night sweats, or weight loss > 10%) at baseline who achieved resolution of all B symptoms at any time during the treatment period.
    End point type
    Other pre-specified
    End point timeframe
    up to 12 months
    End point values
    		 Brentuximab vedotin
    Number of subjects analysed
    17 [10]
    Units: Percent of Participants
    number (confidence interval 95%)
        B Symptom Resolution
    82 (56.6 to 96.2)
    Notes
    [10] - Participants with B symptoms at baseline
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    up to 12 months
    Adverse event reporting additional description
    Treatment-emergent adverse events (TEAE) defined as newly occurring (not present at baseline) or worsening after first dose of investigational product
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13
    Reporting groups
    Reporting group title
    Brentuximab vedotin
    Reporting group description
    		 Brentuximab vedotin

    Serious adverse events
    		 Brentuximab vedotin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    25 / 58 (43.10%)
         number of deaths (all causes)
    25
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anaplastic large cell lymphoma T- and null-cell types recurrent
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 3
    Mycosis fungoides
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tumour flare
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Generalised oedema
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sudden death
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Tracheal disorder
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Mental status changes
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Lower limb fracture
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Arrhythmia supraventricular
         subjects affected / exposed
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bradycardia
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Demyelinating polyneuropathy
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Encephalopathy
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neuralgia
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Peripheral motor neuropathy
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Spinal cord compression
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Retinal vein occlusion
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash papular
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal Failure Acute
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Musculoskeletal and connective tissue disorders
    Myositis
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pain in extremity
         subjects affected / exposed
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Endocarditis staphylococcal
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Klebsiella bacteraemia
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Septic shock
         subjects affected / exposed
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Superinfection bacterial
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fluid overload
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tumour lysis syndrome
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Brentuximab vedotin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    58 / 58 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anaplastic large cell lymphoma T- and null-cell types recurrent
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Tumour flare
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    4
    Vascular disorders
    Hot flush
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    4
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    5
    Chills
         subjects affected / exposed
    8 / 58 (13.79%)
         occurrences all number
    11
    Fatigue
         subjects affected / exposed
    22 / 58 (37.93%)
         occurrences all number
    27
    Oedema peripheral
         subjects affected / exposed
    8 / 58 (13.79%)
         occurrences all number
    9
    Pain
         subjects affected / exposed
    6 / 58 (10.34%)
         occurrences all number
    7
    Pyrexia
         subjects affected / exposed
    20 / 58 (34.48%)
         occurrences all number
    25
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    10 / 58 (17.24%)
         occurrences all number
    10
    Dyspnoea
         subjects affected / exposed
    11 / 58 (18.97%)
         occurrences all number
    12
    Oropharyngeal pain
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    4
    Productive cough
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    4
    Confusional state
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Depression
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    4
    Insomnia
         subjects affected / exposed
    9 / 58 (15.52%)
         occurrences all number
    10
    Investigations
    Weight decreased
         subjects affected / exposed
    8 / 58 (13.79%)
         occurrences all number
    10
    Injury, poisoning and procedural complications
    Excoriation
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    9 / 58 (15.52%)
         occurrences all number
    9
    Headache
         subjects affected / exposed
    11 / 58 (18.97%)
         occurrences all number
    15
    Memory impairment
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Neuralgia
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    5
    Paraesthesia
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    6
    Peripheral motor neuropathy
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    4
    Peripheral sensory neuropathy
         subjects affected / exposed
    24 / 58 (41.38%)
         occurrences all number
    43
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    6
    Lymphadenopathy
         subjects affected / exposed
    6 / 58 (10.34%)
         occurrences all number
    9
    Neutropenia
         subjects affected / exposed
    11 / 58 (18.97%)
         occurrences all number
    14
    Thrombocytopenia
         subjects affected / exposed
    8 / 58 (13.79%)
         occurrences all number
    10
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Abdominal pain
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    5
    Constipation
         subjects affected / exposed
    12 / 58 (20.69%)
         occurrences all number
    12
    Diarrhoea
         subjects affected / exposed
    16 / 58 (27.59%)
         occurrences all number
    19
    Dyspepsia
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    5
    Gastrooesophageal reflux disease
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Haemorrhoids
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Nausea
         subjects affected / exposed
    23 / 58 (39.66%)
         occurrences all number
    28
    Oral pain
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    5
    Vomiting
         subjects affected / exposed
    9 / 58 (15.52%)
         occurrences all number
    11
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    8 / 58 (13.79%)
         occurrences all number
    8
    Dermatitis
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    5
    Dry skin
         subjects affected / exposed
    6 / 58 (10.34%)
         occurrences all number
    10
    Night sweats
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    4
    Pruritus
         subjects affected / exposed
    11 / 58 (18.97%)
         occurrences all number
    12
    Rash
         subjects affected / exposed
    14 / 58 (24.14%)
         occurrences all number
    23
    Rash pruritic
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    6
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    7
    Back pain
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    5
    Groin pain
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    5
    Muscle spasms
         subjects affected / exposed
    8 / 58 (13.79%)
         occurrences all number
    9
    Musculoskeletal pain
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    4
    Myalgia
         subjects affected / exposed
    9 / 58 (15.52%)
         occurrences all number
    10
    Neck pain
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    5
    Pain in extremity
         subjects affected / exposed
    6 / 58 (10.34%)
         occurrences all number
    6
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    5
    Folliculitis
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    6
    Nasopharyngitis
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    4
    Sinusitis
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    4
    Upper respiratory tract infection
         subjects affected / exposed
    11 / 58 (18.97%)
         occurrences all number
    14
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    8 / 58 (13.79%)
         occurrences all number
    8
    Dehydration
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Hyperglycaemia
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Hypokalaemia
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    5
    Hypomagnesaemia
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Dec 2008
    Increased sample size from 30 to 55 patients. CD30 assessment was to be centrally confirmed. Explained why no formal interim efficacy and/or futility analyses were planned. Specified how patients who do not have the correct histological cancer type will be handled in the analysis.
    13 Feb 2009
    Allowed patients 12 years or older to enroll at sites in Canada. Refined entry criteria to ensure that all patients have active relapsed or refractory systemic ALCL at study entry. Increased the time since immunotherapy before study entry to ensure any therapeutic benefit is realized. Added descriptions of interim analyses that may be conducted for scientific meetings and/or regulatory submissions.
    16 Nov 2009
    Allowed patients who have previously received treatment with non-anthracycline or anthracendione-based multi-agent chemotherapy regimens to enroll in the study provided they had received a frontline multi-agent chemotherapy regimen with curative intent. Removed the requirement for central pathology review to confirm CD30-positivity at the time of enrollment. Slides were to be submitted for central review prior to initiation of treatment with brentuximab vedotin. Clarified that prior treatments must have been completed in the protocol-specified timeframe unless patient was progressing on therapy. Updated baseline platelet and bilirubin requirements for patients with bone marrow and hepatic lymphoma involvement. Clarified that patients with active infections Grade 3 or higher are not eligible for the study.
    03 Oct 2011
    Added a section to the protocol regarding the management of suspected progressive multifocal leukoencephalopathy (PML).
    30 Jan 2012
    Revised the timing of assessments during the study follow-up period.
    10 Oct 2013
    Removed the requirement for CT scanning during the long-term follow-up period. CT scans will only be done if progression is suspected based on clinical signs and symptoms. Added a long-term follow-up questionnaire to be taken by patients who remain in remission.

    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/22614995
    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.

    European Medicines Agency © 1995-Sat Apr 27 19:09:12 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA