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A Phase 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial)

Sponsor
Seagen Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01100502
Collaborator
Millennium Pharmaceuticals, Inc. (Industry)
329
Enrollment
87
Locations
2
Arms
119.9
Actual Duration (Months)
3.8
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomized, double-blind, placebo-controlled, multicenter phase 3 trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) and best supportive care (BSC) compared to placebo and BSC in treatment of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT).

Condition or Disease Intervention/Treatment Phase
  • Drug: brentuximab vedotin
  • Drug: placebo
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
329 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of SGN-35 and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Patients at High Risk of Residual Hodgkin Lymphoma Following Autologous Stem Cell Transplant
Actual Study Start Date :
Apr 30, 2010
Actual Primary Completion Date :
Aug 31, 2014
Actual Study Completion Date :
Apr 27, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Brentuximab vedotin

brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion

Drug: brentuximab vedotin
Every 21 days by IV infusion (1.8 mg/kg)
Other Names:
  • SGN-35
  • Adcetris

    		•
    Placebo Comparator: Placebo

    placebo every 3 weeks by IV infusion

    Drug: placebo
    Every 21 days by IV infusion

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free Survival by Independent Review [Up to approximately 4 years]

      Time from date of randomization to the first documentation of disease progression by independent review or to death due to any cause, whichever comes first

    Secondary Outcome Measures

    1. Overall Survival [Up to approximately 10 years]

      Time from date of randomization to date of death due to any cause

    2. Incidence of Adverse Events or Laboratory Abnormalities [Up to 12 months]

    3. Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin [Up to 12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients with HL who have received ASCT in the previous 30-45 days

    • Patients at high risk of residual HL post ASCT

    • Histologically-confirmed HL

    • ECOG of 0 or 1

    • Adequate organ function

    Exclusion Criteria:

    • Previous treatment with brentuximab vedotin

    • Previously received an allogeneic transplant

    • Patients who were determined to have a best clinical response of progressive disease with salvage treatment immediately prior to ASCT

    • History of another primary malignancy that has not been in remission for at least 3 years

    • Post ASCT or current therapy with other systemic anti-neoplastic or investigational agents

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope National Medical Center Duarte California United States 91010-3000
    2 University of California at San Francisco San Francisco California United States 94134
    3 Stanford Cancer Center Stanford California United States 94305
    4 Colorado Blood Cancer Institute Denver Colorado United States 80218
    5 H. Lee Moffitt Cancer Center & Research Institute Tampa Florida United States 33612
    6 Northside Hospital Atlanta Georgia United States 30342
    7 Northwestern University Chicago Illinois United States 60611
    8 University of Chicago Section of Hematology/Oncology Lymphoma Program Chicago Illinois United States 60637-1470
    9 Cardinal Bernardin Cancer Center / Loyola University Medical Center Maywood Illinois United States 60153
    10 Indiana University School of Medicine Simon Cancer Center 535 Barnhill Drive, RT 380 Indianapolis Indiana United States 46202
    11 Johns Hopkins Medical Center Baltimore Maryland United States 21231
    12 Dana Farber Cancer Institute Boston Massachusetts United States 02215
    13 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109
    14 Karmanos Cancer Institute / Wayne State University Detroit Michigan United States 48201
    15 University of Minnesota Minneapolis Minnesota United States 55455
    16 Washington University School of Medicine Saint Louis Missouri United States 63110
    17 Hackensack University Medical Center Hackensack New Jersey United States 07601
    18 New York University Cancer Institute New York New York United States 10016
    19 Memorial Sloan Kettering Cancer Center New York New York United States 10021
    20 University of Rochester Medical Center Rochester New York United States 14642
    21 UNC Lineberger Comprehensive Cancer Center / University of North Carolina Chapel Hill North Carolina United States 27599
    22 Cleveland Clinic, The Cleveland Ohio United States 44195
    23 James Cancer Hospital / Ohio State University Columbus Ohio United States 43210
    24 Oregon Health and Science University / Center for Hematologic Malignancies Portland Oregon United States 97239-3098
    25 Temple Bone Marrow Transplant Program Philadelphia Pennsylvania United States 19111
    26 Western Pennsylvania Cancer Institute Pittsburgh Pennsylvania United States 15224
    27 Saint Francis Hospital Greenville South Carolina United States 29601
    28 Cancer Center of the Carolinas Greenville South Carolina United States 29615
    29 Baylor University Medical Center Dallas Texas United States 75246
    30 MD Anderson Cancer Center / University of Texas Houston Texas United States 77030-4095
    31 Virginia Commonwealth University Medical Center Richmond Virginia United States 23298
    32 Fred Hutchinson Cancer Research Center Seattle Washington United States 98109-1024
    33 Specializirana bolnica aktivno lechenie detsa ohcohematologichni zabolyavania Hematologichno Sofia Bulgaria 1527
    34 Specializirana bolnica za aktivno lechenie na hematologichni zabolyavania Sofia Bulgaria 1756
    35 Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie Hradec Kralove Czechia 500 05
    36 Fakultni nemocnice Kralovske Vinohrady-oddeleni klinicke hematologie Praha Czechia 10034
    37 Vseobecni fakultni nemocnice v Prahe-I. interni klinika Praha Czechia 128 08
    38 CHU Nantes - Hopital Hotel Dieu Service Hematologie Nantes France 44000
    39 Service des Maladies du Sang / Hospital Saint Louis Paris France 75475 Cedex 10
    40 CHU Bordeaux Hopital Haut-Levaque Pessac France 33600
    41 Centre Hospitalier Lyon Sud Pierre Benite France 69310
    42 Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer Rouen France 76038
    43 University Hospital of Cologne Koeln Germany 50924
    44 Szent Istvan es Szent Laszlo Korhaz Rendelointezet Haematologiai es Ossejt-transzplantacios osztaly Budapest Hungary 1097
    45 Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika Debrecen Hungary 4004
    46 Medical Center of the University of Pecs, 1st Clinic for Internal Medicine Pecs Hungary
    47 Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont Szeged Hungary 6720
    48 Instituto di Ematologia ed Oncologia Medica Bologna Italy 40138
    49 Azienda Ospedaliera Universitaria San Martino Genova Italy 16132
    50 Istituto Nazionale dei Tumori Milano Italy 20133
    51 Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Kliniczne Gdansk Poland 80-952
    52 Oddzial Transplantacji Szpiku Centrum Onkologii- Instytut M. Sklodowskiej-Curie, Oddzial Gliwicach Gliwice Poland 44-101
    53 Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego Katowice Poland 40-032
    54 Szpital Uniwersytecki w Krakowie Krakow Poland 31-501
    55 Klinika Hematologii, Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi Lodz Poland 93-510
    56 Oddzial Hematoonkologii, Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie Lublin Poland 20-950
    57 MTZ Clinical Research Sp. z o.o. Warsaw Poland 02-106
    58 Klinika Hematologii, Instytut Hematologii i Transfuzjologii Warsaw Poland 02-766
    59 Centrum Onkologii Institut im. Marii Sklodowskiej-Curie Warsaw Poland 02-781
    60 Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular Targu Mures Judetul Mures Romania 540136
    61 Spitalul Clinic de Urgenta pentru Copii Louis Turcanu, Clinica III Pediatrie Timisoara Judetul Timis Romania 300011
    62 Fundeni Clinical Institute Bucharest Romania 022328
    63 Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu Bucharest Romania 022328
    64 Burdenko Central Military Clinical Hospital Moscow Russian Federation 105229
    65 Rossijskij onkologicheskij nauchnyj centr im. N.N. Blokhina RAMN Moscow Russian Federation 115478
    66 Federal Medical Biophysical Center n.a. A.I. Burnazyan Moscow Russian Federation 123098
    67 Gematologicheskj nauchnyj centr RAMN Moscow Russian Federation 125167
    68 Uchrezhdenie Rossijskoj nauk Nauchno-issledovatel'skij institut klinicheskoj immunologii Novosibirsk Russian Federation 630099
    69 Respublikanskaja bol'nica im. V.A. Baranova Petrozavodsk Russian Federation 185019
    70 Leningradskaja oblastnaja klinicheskaja bol'nica St. Petersburg Russian Federation 194291
    71 Sankt-Peterburgskij gosudarstvennyj medicinskij universitet im. akademika I. P. Pavlova St. Petersburg Russian Federation 197022
    72 St. Petersburg Pavlov State Medical University St. Petersburg Russian Federation 197101
    73 Gorodskaya bol'nica #31 St. Petersburg Russian Federation 197110
    74 Federal Center of Heart, Blood and Endocrinology n.a. V.A. Almazov under the Federal Agency for High St. Petersburg Russian Federation 197341
    75 Sverdlovskaja oblastnaja klinicheskaja bol'nica #1 Yekaterinburg Russian Federation 620102
    76 Klinicki centar Srbije, Klinika za hematologiju Belgrad Serbia 11000
    77 Vojnomedicinska akademija, Klinika za hematologiju Belgrad Serbia 11000
    78 Klinicko bolnicki centar "Vojvodina", Klinika za hematologiju Novi Sad Serbia 21000
    79 Complejo Hospitalano de Navarra Servicio Hematologia Pamplona Navarra Spain 31130
    80 Hospital de la Santa Creu i Sant Paul Barcelona Spain 08025
    81 Hospital Clinic i Provincial Servicio Hematologia Barcelona Spain 08036
    82 Centro Oncologico MD Anderson Madrid Spain 28033
    83 Hospital Universitaro de Salamanca Salamanca Spain 37007
    84 Addenbrooke's Hospital Cambridge United Kingdom CB2 0QQ
    85 St James University Hospital Leeds United Kingdom LS9 7TF
    86 Guy's Hospital Haematology Department, 4th Floor Southwark Wing London United Kingdom SE1 9RT
    87 Christie Hospital NHS Foundation Trust Manchester United Kingdom M20 4BX

    Sponsors and Collaborators

    • Seagen Inc.
    • Millennium Pharmaceuticals, Inc.

    Investigators

    • Study Director: Julie Lisano, PharmD, Seagen Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seagen Inc.
    ClinicalTrials.gov Identifier:
    NCT01100502
    Other Study ID Numbers:
    • SGN35-005
    • 2009-016947-20
    First Posted:
    Apr 9, 2010
    Last Update Posted:
    May 14, 2021
    Last Verified:
    Apr 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Seagen Inc.
    Antigens, CD30
    Antibody-Drug Conjugate
    Antibodies, Monoclonal
    Disease, Hodgkin
    Drug Therapy
    Hematologic Diseases
    Immunotherapy
    Lymphoma
    Monomethylauristatin E
    Additional relevant MeSH terms:
    Lymphoma
    Hodgkin Disease
    Brentuximab Vedotin

    Study Results

    Participant Flow

    Recruitment Details Apr 2010-Aug 2014
    Pre-assignment Detail
    Arm/Group Title Brentuximab Vedotin Placebo
    Arm/Group Description brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion placebo every 3 weeks by IV infusion
    Period Title: Overall Study
    STARTED 165 164
    COMPLETED 89 70
    NOT COMPLETED 76 94

    Baseline Characteristics

    Arm/Group Title Brentuximab Vedotin Placebo Total
    Arm/Group Description brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion placebo every 3 weeks by IV infusion Total of all reporting groups
    Overall Participants 165 164 329
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    33
    32
    32
    Sex: Female, Male (Count of Participants)
    Female
    89
    53.9%
    67
    40.9%
    156
    47.4%
    Male
    76
    46.1%
    97
    59.1%
    173
    52.6%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    2
    1.2%
    3
    1.8%
    5
    1.5%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    10
    6.1%
    2
    1.2%
    12
    3.6%
    White
    153
    92.7%
    156
    95.1%
    309
    93.9%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    3
    1.8%
    3
    0.9%
    Region of Enrollment (Count of Participants)
    Russian Federation
    20
    12.1%
    19
    11.6%
    39
    11.9%
    Romania
    4
    2.4%
    6
    3.7%
    10
    3%
    Hungary
    9
    5.5%
    11
    6.7%
    20
    6.1%
    United States
    67
    40.6%
    68
    41.5%
    135
    41%
    United Kingdom
    3
    1.8%
    3
    1.8%
    6
    1.8%
    Spain
    4
    2.4%
    6
    3.7%
    10
    3%
    Czech Republic
    5
    3%
    0
    0%
    5
    1.5%
    Poland
    26
    15.8%
    28
    17.1%
    54
    16.4%
    Italy
    9
    5.5%
    7
    4.3%
    16
    4.9%
    France
    8
    4.8%
    5
    3%
    13
    4%
    Serbia
    3
    1.8%
    6
    3.7%
    9
    2.7%
    Bulgaria
    7
    4.2%
    2
    1.2%
    9
    2.7%
    Germany
    0
    0%
    3
    1.8%
    3
    0.9%
    Eastern Cooperative Oncology Group Performance Status (Count of Participants)
    0
    87
    52.7%
    97
    59.1%
    184
    55.9%
    1
    77
    46.7%
    67
    40.9%
    144
    43.8%
    2
    1
    0.6%
    0
    0%
    1
    0.3%
    Hodgkin Lymphoma Status after end of Frontline Therapy (Count of Participants)
    Refractory
    99
    60%
    97
    59.1%
    196
    59.6%
    Relapse in less than 12 months
    53
    32.1%
    54
    32.9%
    107
    32.5%
    Relapse 12 months or later with extranodal disease
    13
    7.9%
    13
    7.9%
    26
    7.9%
    Best Response to Salvage Therapy pre-ASCT (Count of Participants)
    Complete remission
    61
    37%
    62
    37.8%
    123
    37.4%
    Partial remission
    57
    34.5%
    56
    34.1%
    113
    34.3%
    Stable disease
    47
    28.5%
    46
    28%
    93
    28.3%

    Outcome Measures

    1. Primary Outcome
    Title Progression-free Survival by Independent Review
    Description Time from date of randomization to the first documentation of disease progression by independent review or to death due to any cause, whichever comes first
    Time Frame Up to approximately 4 years

    Outcome Measure Data

    Analysis Population Description
    Intention-to-Treat analysis set
    Arm/Group Title Brentuximab Vedotin Placebo
    Arm/Group Description brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion placebo every 3 weeks by IV infusion
    Measure Participants 165 164
    Median (95% Confidence Interval) [months]
    42.9
    24.1
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Brentuximab Vedotin, Placebo
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.001
    Comments
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.57
    Confidence Interval (2-Sided) 95%
    0.40 to 0.81
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Overall Survival
    Description Time from date of randomization to date of death due to any cause
    Time Frame Up to approximately 10 years

    Outcome Measure Data

    Analysis Population Description
    Intention-to-Treat analysis set
    Arm/Group Title Brentuximab Vedotin Placebo
    Arm/Group Description brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion placebo every 3 weeks by IV infusion
    Measure Participants 165 164
    Median (Full Range) [months]
    NA
    NA
    3. Secondary Outcome
    Title Incidence of Adverse Events or Laboratory Abnormalities
    Description
    Time Frame Up to 12 months

    Outcome Measure Data

    Analysis Population Description
    Safety Analysis Set includes all patients who received at least 1 dose of brentuximab vedotin or only received placebo: 2 patients randomized to placebo received a single dose of brentuximab vedotin and are included in the brentuximab vedotin arm; 2 patients randomized to placebo received no study treatment and are not included in the analysis
    Arm/Group Title Brentuximab Vedotin Placebo
    Arm/Group Description brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion placebo every 3 weeks by IV infusion
    Measure Participants 167 160
    Any Treatment-Emergent Adverse Event
    163
    98.8%
    142
    86.6%
    Any Treatment-Related Adverse Event
    147
    89.1%
    79
    48.2%
    Any Adverse Event with Severity >= Grade 3
    93
    56.4%
    51
    31.1%
    Any Serious Adverse Event
    41
    24.8%
    20
    12.2%
    Any Treatment-Related Serious Adverse Events
    19
    11.5%
    7
    4.3%
    Treatment Discontinuation Due to Adverse Event
    54
    32.7%
    10
    6.1%
    Any Laboratory Abnormalities Severity >=Grade 3
    69
    41.8%
    29
    17.7%
    4. Secondary Outcome
    Title Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin
    Description
    Time Frame Up to 12 months

    Outcome Measure Data

    Analysis Population Description
    ATA-evaluable patients (patients with a baseline and at least 1 postbaseline sample)
    Arm/Group Title Brentuximab Vedotin Placebo
    Arm/Group Description brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion placebo every 3 weeks by IV infusion
    Measure Participants 157 154
    Baseline Negative
    138
    83.6%
    142
    86.6%
    Baseline Negative: -'ve Postbaseline
    92
    55.8%
    104
    63.4%
    Baseline Negative: Transiently +'ve Postbaseline
    36
    21.8%
    27
    16.5%
    Baseline Negative: Persistently +'ve Postbaseline
    10
    6.1%
    11
    6.7%
    Baseline Positive
    19
    11.5%
    12
    7.3%
    Baseline Positive: -'ve Postbaseline
    7
    4.2%
    0
    0%
    Baseline Positive: Transiently +'ve Postbaseline
    9
    5.5%
    5
    3%
    Baseline Positive: Persistently +'ve Postbaseline
    3
    1.8%
    7
    4.3%

    Adverse Events

    Time Frame Non-serious adverse events were followed for up to 15 months. Serious adverse event data were collected for up to approximately 10 years (116 months).
    Adverse Event Reporting Description Safety Analysis Set includes all patients who received at least 1 dose of brentuximab vedotin or only received placebo: 2 patients randomized to placebo received a single dose of brentuximab vedotin and are included in the brentuximab vedotin arm; 2 patients randomized to placebo received no study treatment and are not included in the analysis
    Arm/Group Title Placebo Brentuximab Vedotin
    Arm/Group Description placebo every 3 weeks by IV infusion brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
    All Cause Mortality
    Placebo Brentuximab Vedotin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 40/160 (25%) 45/167 (26.9%)
    Serious Adverse Events
    Placebo Brentuximab Vedotin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 21/160 (13.1%) 43/167 (25.7%)
    Blood and lymphatic system disorders
    Bone marrow failure 1/160 (0.6%) 0/167 (0%)
    Neutropenia 1/160 (0.6%) 1/167 (0.6%)
    Thrombocytopenia 2/160 (1.3%) 0/167 (0%)
    Cardiac disorders
    Bradycardia 0/160 (0%) 1/167 (0.6%)
    Cardiac failure congestive 0/160 (0%) 1/167 (0.6%)
    Myocardial infarction 0/160 (0%) 1/167 (0.6%)
    Pericardial effusion 1/160 (0.6%) 0/167 (0%)
    Sinus tachycardia 0/160 (0%) 1/167 (0.6%)
    Gastrointestinal disorders
    Abdominal pain 1/160 (0.6%) 1/167 (0.6%)
    Constipation 0/160 (0%) 2/167 (1.2%)
    Diarrhoea 1/160 (0.6%) 1/167 (0.6%)
    Epigastric discomfort 0/160 (0%) 1/167 (0.6%)
    Erosive duodenitis 0/160 (0%) 1/167 (0.6%)
    Gastrointestinal haemorrhage 1/160 (0.6%) 0/167 (0%)
    Nausea 1/160 (0.6%) 4/167 (2.4%)
    Pancreatitis acute 0/160 (0%) 1/167 (0.6%)
    Vomiting 1/160 (0.6%) 5/167 (3%)
    General disorders
    Asthenia 0/160 (0%) 1/167 (0.6%)
    Disease progression 0/160 (0%) 1/167 (0.6%)
    Pyrexia 2/160 (1.3%) 6/167 (3.6%)
    Hepatobiliary disorders
    Hepatotoxicity 1/160 (0.6%) 3/167 (1.8%)
    Infections and infestations
    Acute hepatitis b 0/160 (0%) 1/167 (0.6%)
    Appendicitis 0/160 (0%) 1/167 (0.6%)
    Hepatic candidiasis 0/160 (0%) 1/167 (0.6%)
    Herpes zoster 1/160 (0.6%) 2/167 (1.2%)
    Pneumocystis jirovecii pneumonia 0/160 (0%) 1/167 (0.6%)
    Pneumonia 4/160 (2.5%) 7/167 (4.2%)
    Septic shock 1/160 (0.6%) 0/167 (0%)
    Sinusitis 1/160 (0.6%) 0/167 (0%)
    Upper respiratory tract infection 1/160 (0.6%) 1/167 (0.6%)
    Injury, poisoning and procedural complications
    Radiation myelopathy 0/160 (0%) 1/167 (0.6%)
    Investigations
    Blood bilirubin increased 1/160 (0.6%) 0/167 (0%)
    Metabolism and nutrition disorders
    Hyperglycaemia 0/160 (0%) 1/167 (0.6%)
    Musculoskeletal and connective tissue disorders
    Bone pain 1/160 (0.6%) 0/167 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia 1/160 (0.6%) 1/167 (0.6%)
    Anogenital warts 0/160 (0%) 1/167 (0.6%)
    Bladder cancer 0/160 (0%) 1/167 (0.6%)
    Brain neoplasm 0/160 (0%) 1/167 (0.6%)
    Mantle cell lymphoma 1/160 (0.6%) 0/167 (0%)
    Metastases to spine 1/160 (0.6%) 0/167 (0%)
    Myelodysplastic syndrome 1/160 (0.6%) 1/167 (0.6%)
    Nervous system disorders
    Basilar migraine 0/160 (0%) 1/167 (0.6%)
    Headache 0/160 (0%) 2/167 (1.2%)
    Neuralgia 0/160 (0%) 1/167 (0.6%)
    Peripheral motor neuropathy 0/160 (0%) 1/167 (0.6%)
    Peripheral sensory neuropathy 0/160 (0%) 3/167 (1.8%)
    Presyncope 0/160 (0%) 1/167 (0.6%)
    Syncope 0/160 (0%) 1/167 (0.6%)
    Psychiatric disorders
    Anxiety 1/160 (0.6%) 0/167 (0%)
    Depression 0/160 (0%) 1/167 (0.6%)
    Depression suicidal 1/160 (0.6%) 0/167 (0%)
    Suicidal ideation 0/160 (0%) 1/167 (0.6%)
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome 1/160 (0.6%) 2/167 (1.2%)
    Asthma 1/160 (0.6%) 0/167 (0%)
    Bronchospasm 0/160 (0%) 1/167 (0.6%)
    Idiopathic pneumonia syndrome 1/160 (0.6%) 0/167 (0%)
    Lung infiltration 1/160 (0.6%) 0/167 (0%)
    Pneumonitis 0/160 (0%) 2/167 (1.2%)
    Pulmonary embolism 0/160 (0%) 1/167 (0.6%)
    Pulmonary toxicity 0/160 (0%) 1/167 (0.6%)
    Skin and subcutaneous tissue disorders
    Pruritus 0/160 (0%) 1/167 (0.6%)
    Rash 0/160 (0%) 1/167 (0.6%)
    Dermatitis allergic 0/160 (0%) 2/167 (1.2%)
    Vascular disorders
    Pelvic venous thrombosis 0/160 (0%) 1/167 (0.6%)
    Hypotension 0/160 (0%) 1/167 (0.6%)
    Other (Not Including Serious) Adverse Events
    Placebo Brentuximab Vedotin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 127/160 (79.4%) 151/167 (90.4%)
    Blood and lymphatic system disorders
    Anaemia 4/160 (2.5%) 14/167 (8.4%)
    Leukopenia 3/160 (1.9%) 9/167 (5.4%)
    Neutropenia 18/160 (11.3%) 58/167 (34.7%)
    Thrombocytopenia 3/160 (1.9%) 12/167 (7.2%)
    Cardiac disorders
    Sinus tachycardia 3/160 (1.9%) 9/167 (5.4%)
    Gastrointestinal disorders
    Abdominal pain 5/160 (3.1%) 20/167 (12%)
    Constipation 5/160 (3.1%) 20/167 (12%)
    Diarrhoea 15/160 (9.4%) 33/167 (19.8%)
    Dyspepsia 6/160 (3.8%) 11/167 (6.6%)
    Nausea 12/160 (7.5%) 34/167 (20.4%)
    Vomiting 11/160 (6.9%) 24/167 (14.4%)
    General disorders
    Asthenia 7/160 (4.4%) 13/167 (7.8%)
    Chills 8/160 (5%) 17/167 (10.2%)
    Fatigue 29/160 (18.1%) 40/167 (24%)
    Non-cardiac chest pain 9/160 (5.6%) 6/167 (3.6%)
    Oedema peripheral 10/160 (6.3%) 8/167 (4.8%)
    Pain 5/160 (3.1%) 11/167 (6.6%)
    Pyrexia 23/160 (14.4%) 27/167 (16.2%)
    Infections and infestations
    Bronchitis 10/160 (6.3%) 10/167 (6%)
    Herpes zoster 3/160 (1.9%) 10/167 (6%)
    Pharyngitis 4/160 (2.5%) 8/167 (4.8%)
    Sinusitis 10/160 (6.3%) 4/167 (2.4%)
    Upper respiratory tract infection 37/160 (23.1%) 43/167 (25.7%)
    Investigations
    Weight decreased 9/160 (5.6%) 31/167 (18.6%)
    Weight increased 14/160 (8.8%) 5/167 (3%)
    Metabolism and nutrition disorders
    Decreased appetite 9/160 (5.6%) 20/167 (12%)
    Hypokalaemia 6/160 (3.8%) 10/167 (6%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 15/160 (9.4%) 30/167 (18%)
    Back pain 16/160 (10%) 15/167 (9%)
    Muscle spasms 9/160 (5.6%) 18/167 (10.8%)
    Muscular weakness 1/160 (0.6%) 8/167 (4.8%)
    Myalgia 7/160 (4.4%) 15/167 (9%)
    Pain in extremity 8/160 (5%) 11/167 (6.6%)
    Nervous system disorders
    Headache 13/160 (8.1%) 18/167 (10.8%)
    Paraesthesia 2/160 (1.3%) 16/167 (9.6%)
    Peripheral motor neuropathy 3/160 (1.9%) 37/167 (22.2%)
    Peripheral sensory neuropathy 25/160 (15.6%) 92/167 (55.1%)
    Psychiatric disorders
    Anxiety 13/160 (8.1%) 14/167 (8.4%)
    Insomnia 5/160 (3.1%) 14/167 (8.4%)
    Respiratory, thoracic and mediastinal disorders
    Cough 26/160 (16.3%) 35/167 (21%)
    Dyspnoea 10/160 (6.3%) 21/167 (12.6%)
    Oropharyngeal pain 8/160 (5%) 8/167 (4.8%)
    Skin and subcutaneous tissue disorders
    Dry skin 7/160 (4.4%) 10/167 (6%)
    Night sweats 18/160 (11.3%) 12/167 (7.2%)
    Pruritus 14/160 (8.8%) 22/167 (13.2%)
    Rash 5/160 (3.1%) 14/167 (8.4%)
    Vascular disorders
    Hypotension 4/160 (2.5%) 9/167 (5.4%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Chief Medical Officer
    Organization Seagen Inc.
    Phone (855)473-2436
    Email medinfo@seagen.com
    Responsible Party:
    Seagen Inc.
    ClinicalTrials.gov Identifier:
    NCT01100502
    Other Study ID Numbers:
    • SGN35-005
    • 2009-016947-20
    First Posted:
    Apr 9, 2010
    Last Update Posted:
    May 14, 2021
    Last Verified:
    Apr 1, 2021