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ECHELON-2: A Comparison of Brentuximab Vedotin and CHP With Standard-of-care CHOP in the Treatment of Patients With CD30-positive Mature T-cell Lymphomas

Sponsor
Seagen Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01777152
Collaborator
Millennium Pharmaceuticals, Inc. (Industry)
452
Enrollment
144
Locations
2
Arms
92
Actual Duration (Months)
3.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a double-blind, randomized, multicenter, phase 3 clinical trial to compare the efficacy and safety of brentuximab vedotin in combination with CHP with the standard-of-care CHOP in patients with CD30-positive mature T-cell lymphomas.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
452 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) Versus CHOP in the Frontline Treatment of Patients With CD30-positive Mature T-cell Lymphomas
Actual Study Start Date :
Jan 31, 2013
Actual Primary Completion Date :
Aug 15, 2018
Actual Study Completion Date :
Oct 2, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: CHOP

cyclophosphamide, doxorubicin, vincristine, and prednisone

Drug: doxorubicin
50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles

Drug: prednisone
100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles

Drug: vincristine
1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles

Drug: cyclophosphamide
750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
Experimental: A+CHP

brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone

Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles
Other Names:
  • Adcetris; SGN-35

    • Drug: doxorubicin
    50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles

    Drug: prednisone
    100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles

    Drug: cyclophosphamide
    750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free Survival Per Independent Review Facility (IRF) [Up to 60 months]

      The time from the date of randomization to the date of first documentation of progressive disease (PD), death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease whichever occurred first.

    Secondary Outcome Measures

    1. Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL) [Up to 60 months]

      The time from the date of randomization to the date of first documentation of progressive disease (PD), death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease whichever occurred first.

    2. Complete Remission (CR) Rate Per IRF at End of Treatment (EOT) [Up to 8.34 months]

      The count of participants with CR per IRF following the completion of study treatment (at end of treatment or at the first assessment after the last dose of study treatment and prior to long-term follow-up) according to the Revised Response Criteria for Malignant Lymphoma.

    3. Overall Survival (OS) [Up to 90 months]

      The time from randomization to death due to any cause.

    4. Objective Response Rate (ORR) Per IRF at End of Treatment [Up to 8.34 months]

      The count of participants with CR or partial response (PR) per IRF following the completion of study treatment (at end of treatment or the first assessment after the last dose of study treatment and prior to long-term follow-up) according to the Revised Response Criteria for Malignant Lymphoma.

    5. Incidence of Adverse Events (AEs) [Up to 8.28 months]

      Any untoward medical occurrence in a clinical investigational participant administered a medicinal product which does not necessarily have a causal relationship with this treatment.

    6. Incidence of Laboratory Abnormalities [Up to 8.28 months]

      Number of participants who experienced a Grade 3 or higher laboratory toxicity.

    Eligibility Criteria

    Criteria

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

    • Patients with newly diagnosed, CD30-positive mature T-cell lymphomas

    • Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm by CT

    • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

    Exclusion Criteria:

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

    • Current diagnosis of primary cutaneous CD30-positive T-cell lymphoproliferative disorders and lymphomas or mycosis fungoides

    • History of progressive multifocal leukoencephalopathy (PML)

    • Cerebral/meningeal disease related to the underlying malignancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Banner MD Anderson Cancer Center Gilbert Arizona United States 85234
    2 City of Hope National Medical Center Duarte California United States 91010-3000
    3 Stanford Cancer Center Stanford California United States 94305
    4 Shands Cancer Center / University of Florida Gainesville Florida United States 32610
    5 Orlando Health, Inc. Orlando Florida United States 32806
    6 University of Illinois at Chicago Chicago Illinois United States 60612
    7 Cardinal Bernardin Cancer Center / Loyola University Medical Center Maywood Illinois United States 60153
    8 Holden Comprehensive Cancer Center / University of Iowa Iowa City Iowa United States 52242
    9 University of Kansas Cancer Center Westwood Kansas United States United States
    10 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    11 Dana Farber Cancer Institute Boston Massachusetts United States 02215
    12 Washington University School of Medicine Saint Louis Missouri United States 63110
    13 Memorial Sloan Kettering Cancer Center - Basking Ridge Basking Ridge New Jersey United States 07920
    14 Hackensack University Medical Center Hackensack New Jersey United States 07601
    15 Albert Einstein Cancer Center Bronx New York United States 10461
    16 Montefiore Medical Center Bronx New York United States 10467
    17 Memorial Sloan Kettering Cancer Center - Commack Commack New York United States 11725
    18 Memorial Sloan Kettering Cancer Center New York New York United States 10021
    19 Columbia University Medical Center New York New York United States 10022
    20 Weill Cornell Medical College New York New York United States 10065
    21 James P. Wilmot Cancer Center / University of Rochester Medical Center Rochester New York United States 14642
    22 Jewish Hospital, The Cincinnati Ohio United States 45236
    23 Cleveland Clinic, The Cleveland Ohio United States 44195
    24 Mercy Clinic Oncology Oklahoma City Oklahoma United States 73120
    25 Thomas Jefferson University Philadelphia Pennsylvania United States United States
    26 Sarah Cannon Research Institute Nashville Tennessee United States 30384
    27 Charles A. Sammons Cancer Center / Baylor University Medical Center Dallas Texas United States 75246
    28 MD Anderson Cancer Center / University of Texas Houston Texas United States 77030-4095
    29 University of Virginia Charlottesville Virginia United States 22908
    30 Virginia Commonwealth University Medical Center Richmond Virginia United States 23298
    31 Benaroya Research Institute/Virginia Mason Medical Center Seattle Washington United States 98101
    32 Seattle Cancer Care Alliance / University of Washington Seattle Washington United States 98109-1023
    33 Royal Adelaide Hospital Adelaide Australia 5000
    34 Moorabbin Hospital Bentleigh East Australia 3165
    35 Icon Cancer Care Chermside Chermside Australia 4032
    36 Icon Cancer Care South Brisbane Chermside Australia 4032
    37 Icon Cancer Care Southport Chermside Australia 4032
    38 Icon Cancer Care Wesley Chermside Australia 4032
    39 Monash Medical Centre Clayton Australia 3168
    40 Concord Repatriation General Hospital Concord Australia 2139
    41 St. Vincent's Hospital Sydney Darlinghurst Australia 2010
    42 St Vincent's Public Hospital Sydney - Fitzroy Fitzroy Australia 3065
    43 Western Hospital Footscray Australia 3011
    44 Austin Health Heidelberg Australia 3084
    45 Calvary Mater Newcastle Waratah Australia 2298
    46 McGill University Department of Oncology / McGill University Health Centre Montreal Canada H3H 2R9
    47 Jewish General Hospital Montreal Canada H3T 1E2
    48 Sunnybrook Health Sciences Centre Toronto Canada M4N 3M5
    49 British Columbia Cancer Agency - Vancouver Centre Vancouver Canada V5Z 4E6
    50 Fakultni nemocnice Brno Brno Czechia 625 00
    51 Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie Hradec Kralove Czechia 500 05
    52 Fakultni Nemocnice Ostrava Ostrava - Poruba Czechia 708 52
    53 Fakultni Nemocnice Kralovske Vinohrady Praha 10 Czechia 100 34
    54 Vseobecna fakultni nemocnice v Praze Praha 2 Czechia 128 08
    55 Aarhus University Hospital Aarhus C. Denmark 8000
    56 Rigs Hospiltalet Copenhagen Denmark DK 2100
    57 Odense University Hospital Odense C Denmark 5000
    58 Hôpital Henri Mondor Créteil France 94010
    59 CHD Vendée, Site de La Roche-sur-Yon, Les Oudairies La Roche-sur-Yon Cedex 9 France 85925
    60 Centre Hospitalier Universitaire de Grenoble La Tronche France 38700
    61 Clinique Victor Hugo Le Mans France 72000
    62 CHRU de Lille Lille cedex France 59037
    63 Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren Limoges Cedex France 87042
    64 Centre Hospitalier Universitaire Nantes-Hotel Dieu Nantes cedex 1 France 44093
    65 Hopital Saint-Louis / Service d'Hematologie Paris Cedex 10 France 75475
    66 Groupe Hospitalier Pitié-Salpétrière Paris France 75013
    67 Groupe Hospitalier du Haut Leveque Pessac France 33604
    68 Centre Hospitalier Lyon Sud Pierre Bénite Cedex France 69495
    69 Centre Hospitalier Universitaire de Poitiers Poitiers Cedex France 86021
    70 Centre Hospitalier Universitaire de Rennes, Hopital Pontchaillou Rennes Cedex 9 France 35033
    71 Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer Rouen France 76038
    72 Charite Universitatsmedizin Berlin Berlin Germany 10117
    73 Charite Campus Benjamin Franklin Berlin Germany 12203
    74 Klinikum Chemnitz gGmbH Chemnitz Germany 09113
    75 Universitatsklinikum Essen Essen Germany 45122
    76 Krankenhaus Nordwest GmbH Frankfurt am Main Germany 60488
    77 Georg-August-Universität Göttingen Göttingen Germany 37075
    78 Universitätsklinikum Heidelberg Heidelberg Germany 69120
    79 Universitätsklinikum des Saarlandes Homburg/Saar Germany 66421
    80 Klinik für Innere Medizin II, Friedrich-Schiller-Universität Jena Germany 07747
    81 Universitatsklinikum Koln Köln Germany 50937
    82 Klinikum der Ludwig-Maximilians-Universität München München Germany 81377
    83 Klinikum Nürnberg Nürnberg Germany 90419
    84 Universitätsklinikum Ulm Ulm Germany 89081
    85 Semmelweis Egyetem Budapest Hungary 1083
    86 Debreceni Egyetem Debrecen Hungary 4032
    87 Somogy Megyei Kaposi Mór Oktató Kórház Kaposvár Hungary 7400
    88 Markusovszky Egyetemi Oktatokorhaz Szombathely Hungary 9700
    89 Soroka Medical Center, Dept. of Oncology Beer Sheva Israel 84101
    90 Rambam Health Corp. Haifa Israel 31096
    91 Hadassah Medical Center Jerusalem Israel 91120
    92 Rabin Medical Center Petach Tikva Israel 49414
    93 Tel Aviv Sourasky Medical Center Tel Aviv Israel 64239
    94 Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria Alessandria Italy 15121
    95 Azienda Ospedaliera Papa Giovanni XXIII Bergamo Italy 24127
    96 Instituto di Ematologia ed Oncologia Medica Bologna Italy 40138
    97 Azienda Ospedaliera Spedali Civili di Brescia Brescia Italy 25123
    98 Azienda Ospedaliera-Universitaria Vittorio Emanuele-Ferrarotto-Santo Bambino Catania Italy 95124
    99 Azienda Ospedaliera Universitaria San Martino Genova Italy 16132
    100 Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano Italy 20122
    101 Ospedale Niguarda Ca' Granda Milano Italy 20162
    102 IRCSS Policlinico San Matteo Pavia Italy 27100
    103 Azienda Ospedaliera Ospedali Riuniti Marche Nord Pesaro Italy 61100
    104 Università degli Studi di Roma "La Sapienza, Policlinico Umberto I Roma Italy 00161
    105 Istituto Clinico Humanitas-Humanitas Cancer Center Rozzano Italy 20089
    106 Azienda Ospedaliera Città della Salute e della Scienza di Torino Torino Italy 10126
    107 Azienda Ospedaliera Universitaria Integrata di Verona Verona Italy 37134
    108 Keimyung University Dongsan Medical Center Daegu Korea, Republic of 700-712
    109 Chonnam National University Hwasun Hospital Hwasun Korea, Republic of 519-763
    110 Seoul National University Bundang Hospital Seongnam-si Korea, Republic of 463-707
    111 Seoul National University Hospital Seoul Korea, Republic of 110-744
    112 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of 120-752
    113 Samsung Medical Center Seoul Korea, Republic of 135-710
    114 Seoul Saint Mary's Hospital Seoul Korea, Republic of 137-701
    115 Asan Medical Center Seoul Korea, Republic of 138-876
    116 Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza Brzozow Poland 36-200
    117 Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich Chorzów Poland 41-500
    118 Malopolskie Centrum Medyczne S.C. Krakow Poland 30-510
    119 Centrum Onkologii Institut im. Marii Sklodowskiej-Curie Warsaw Poland 02-781
    120 Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu Bucharest Romania 022328
    121 Spitalul Clinic Coltea Bucuresti Romania 030171
    122 Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj-Napoca Cluj-Napoca Romania 400015
    123 Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular Targu Mures Romania 540136
    124 Hospital de la Santa Creu i Sant Paul Barcelona Spain 08025
    125 Institut Universitari Dexeus Barcelona Spain 08028
    126 Institut Català D'oncologia L'Hospitalet de Llobregat Spain 08907
    127 Hospital de León León Spain 24071
    128 Hospital General Universitario Gregorio Marañon Madrid Spain 28007
    129 Hospital Universitario 12 de Octubre Madrid Spain 28041
    130 Hospital Universitario La Paz Madrid Spain 28046
    131 Hospital Puerta de Hierro Majadahonda Majadahonda Spain 28222
    132 Hospital Universitaro de Salamanca Salamanca Spain 37007
    133 Hospital Universitario Virgen del Rocio Sevilla Spain 41013
    134 Hospital Universitari i Politecnic La Fe de Valencia Valencia Spain 46026
    135 Chang Gung Memorial Hospital - Kaohsiung Kaohsiung Taiwan 83301
    136 China Medical University Hospital Taichung Taiwan 404
    137 National Cheng-Kung University Hospital Tainan Taiwan 70403
    138 Chang Gung Memorial Hospital - Taoyuan Taoyuan Taiwan 33305
    139 Addenbrooke's Hospital Cambridge United Kingdom CB2 0QQ
    140 University Hospitals of Leicester NHS Trust Leicester United Kingdom LE1 5WW
    141 Saint George's Hospital NHS Trust London United Kingdom SW17 0RE
    142 Christie Hospital NHS Foundation Trust Manchester United Kingdom M20 4BX
    143 Freeman Hospital Newcastle upon Tyne United Kingdom NE7 7DN
    144 Nottingham University Hospitals NHS Trust Nottingham United Kingdom NG5 1PD

    Sponsors and Collaborators

    • Seagen Inc.
    • Millennium Pharmaceuticals, Inc.

    Investigators

    • Study Director: Thomas Manley, MD, Seagen Inc.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Seagen Inc.
    ClinicalTrials.gov Identifier:
    NCT01777152
    Other Study ID Numbers:
    • SGN35-014
    • 2012-002751-42
    First Posted:
    Jan 28, 2013
    Last Update Posted:
    Nov 30, 2021
    Last Verified:
    Nov 1, 2021
    Keywords provided by Seagen Inc.
    Antibodies, Monoclonal
    Antibody-Drug Conjugate
    Antigens, CD30
    Drug Therapy
    Hematologic Diseases
    Lymphoma
    Monomethyl auristatin E
    Lymphoma, T-Cell
    Lymphoma, Non-Hodgkin
    Lymphoma, Large-Cell, Anaplastic
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, T-Cell
    Lymphoma, T-Cell, Peripheral
    Lymphoma, Large-Cell, Anaplastic
    Prednisone
    Cyclophosphamide
    Doxorubicin
    Vincristine
    Brentuximab Vedotin

    Study Results

    Participant Flow

    Recruitment Details Jan2013-Nov2016
    Pre-assignment Detail
    Arm/Group Title A+CHP CHOP
    Arm/Group Description brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
    Period Title: Overall Study
    STARTED 226 226
    COMPLETED 131 116
    NOT COMPLETED 95 110

    Baseline Characteristics

    Arm/Group Title A+CHP CHOP Total
    Arm/Group Description brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles Total of all reporting groups
    Overall Participants 226 226 452
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    157
    69.5%
    156
    69%
    313
    69.2%
    >=65 years
    69
    30.5%
    70
    31%
    139
    30.8%
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    58
    58
    58
    Sex: Female, Male (Count of Participants)
    Female
    93
    41.2%
    75
    33.2%
    168
    37.2%
    Male
    133
    58.8%
    151
    66.8%
    284
    62.8%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    10
    4.4%
    4
    1.8%
    14
    3.1%
    Not Hispanic or Latino
    186
    82.3%
    193
    85.4%
    379
    83.8%
    Unknown or Not Reported
    30
    13.3%
    29
    12.8%
    59
    13.1%
    Race/Ethnicity, Customized (Count of Participants)
    Asian
    45
    19.9%
    54
    23.9%
    99
    21.9%
    Black or African American
    12
    5.3%
    6
    2.7%
    18
    4%
    Native Hawaiian or Other Pacific Islander
    1
    0.4%
    0
    0%
    1
    0.2%
    White
    139
    61.5%
    142
    62.8%
    281
    62.2%
    Other
    3
    1.3%
    2
    0.9%
    5
    1.1%
    Unknown
    26
    11.5%
    22
    9.7%
    48
    10.6%
    Region of Enrollment (Count of Participants)
    United States
    70
    31%
    57
    25.2%
    127
    28.1%
    Japan
    20
    8.8%
    23
    10.2%
    43
    9.5%
    South Korea
    17
    7.5%
    23
    10.2%
    40
    8.8%
    Italy
    17
    7.5%
    20
    8.8%
    37
    8.2%
    France
    18
    8%
    18
    8%
    36
    8%
    Germany
    15
    6.6%
    12
    5.3%
    27
    6%
    Spain
    15
    6.6%
    11
    4.9%
    26
    5.8%
    Czechia
    10
    4.4%
    12
    5.3%
    22
    4.9%
    United Kingdom
    7
    3.1%
    14
    6.2%
    21
    4.6%
    Australia
    6
    2.7%
    8
    3.5%
    14
    3.1%
    Denmark
    9
    4%
    5
    2.2%
    14
    3.1%
    Israel
    8
    3.5%
    4
    1.8%
    12
    2.7%
    Hungary
    4
    1.8%
    5
    2.2%
    9
    2%
    Taiwan, Province Of China
    5
    2.2%
    4
    1.8%
    9
    2%
    Poland
    2
    0.9%
    5
    2.2%
    7
    1.5%
    Canada
    3
    1.3%
    3
    1.3%
    6
    1.3%
    Romania
    0
    0%
    2
    0.9%
    2
    0.4%
    Eastern Cooperative Oncology Group (ECOG) Performance Status (Count of Participants)
    Grade 0
    85
    37.6%
    93
    41.2%
    178
    39.4%
    Grade 1
    90
    39.8%
    86
    38.1%
    176
    38.9%
    Grade 2
    51
    22.6%
    47
    20.8%
    98
    21.7%

    Outcome Measures

    1. Primary Outcome
    Title Progression-free Survival Per Independent Review Facility (IRF)
    Description The time from the date of randomization to the date of first documentation of progressive disease (PD), death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease whichever occurred first.
    Time Frame Up to 60 months

    Outcome Measure Data

    Analysis Population Description
    The Intent-to-Treat (ITT) Analysis Set includes all randomized patients. Patients are included in the treatment group assigned at randomization regardless of the actual treatment received.
    Arm/Group Title A+CHP CHOP
    Arm/Group Description brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
    Measure Participants 226 226
    Median (Inter-Quartile Range) [months]
    48.20
    20.80
    2. Secondary Outcome
    Title Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL)
    Description The time from the date of randomization to the date of first documentation of progressive disease (PD), death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease whichever occurred first.
    Time Frame Up to 60 months

    Outcome Measure Data

    Analysis Population Description
    This analysis population includes only patients with systemic anaplastic large cell lymphoma (sALCL).
    Arm/Group Title A+CHP CHOP
    Arm/Group Description brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
    Measure Participants 162 154
    Median (Inter-Quartile Range) [months]
    55.66
    32.03
    3. Secondary Outcome
    Title Complete Remission (CR) Rate Per IRF at End of Treatment (EOT)
    Description The count of participants with CR per IRF following the completion of study treatment (at end of treatment or at the first assessment after the last dose of study treatment and prior to long-term follow-up) according to the Revised Response Criteria for Malignant Lymphoma.
    Time Frame Up to 8.34 months

    Outcome Measure Data

    Analysis Population Description
    The ITT Analysis Set includes all randomized patients. Patients are included in the treatment group assigned at randomization regardless of the actual treatment received.
    Arm/Group Title A+CHP CHOP
    Arm/Group Description brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
    Measure Participants 226 226
    Count of Participants [Participants]
    153
    67.7%
    126
    55.8%
    4. Secondary Outcome
    Title Overall Survival (OS)
    Description The time from randomization to death due to any cause.
    Time Frame Up to 90 months

    Outcome Measure Data

    Analysis Population Description
    The Intent-to-Treat (ITT) Analysis Set includes all randomized patients. Patients are included in the treatment group assigned at randomization regardless of the actual treatment received.
    Arm/Group Title A+CHP CHOP
    Arm/Group Description brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
    Measure Participants 226 226
    Median (Full Range) [Months]
    NA
    NA
    5. Secondary Outcome
    Title Objective Response Rate (ORR) Per IRF at End of Treatment
    Description The count of participants with CR or partial response (PR) per IRF following the completion of study treatment (at end of treatment or the first assessment after the last dose of study treatment and prior to long-term follow-up) according to the Revised Response Criteria for Malignant Lymphoma.
    Time Frame Up to 8.34 months

    Outcome Measure Data

    Analysis Population Description
    The ITT Analysis Set includes all randomized patients. Patients are included in the treatment group assigned at randomization regardless of the actual treatment received.
    Arm/Group Title A+CHP CHOP
    Arm/Group Description brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
    Measure Participants 226 226
    Count of Participants [Participants]
    188
    83.2%
    163
    72.1%
    6. Secondary Outcome
    Title Incidence of Adverse Events (AEs)
    Description Any untoward medical occurrence in a clinical investigational participant administered a medicinal product which does not necessarily have a causal relationship with this treatment.
    Time Frame Up to 8.28 months

    Outcome Measure Data

    Analysis Population Description
    The Safety Analysis Set includes all patients who receive any amount of brentuximab vedotin or any component of CHOP. Treatment group will be determined using the actual treatment received, regardless of the randomization treatment assignment.
    Arm/Group Title A+CHP CHOP
    Arm/Group Description brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
    Measure Participants 223 226
    Any treatment-emergent AE
    221
    97.8%
    221
    97.8%
    Blinded study treatment-related AE
    201
    88.9%
    193
    85.4%
    CHP treatment-related AE
    198
    87.6%
    205
    90.7%
    Any serious adverse event (SAE)
    87
    38.5%
    87
    38.5%
    Blinded study treatment-related SAE
    58
    25.7%
    45
    19.9%
    CHP treatment-related SAE
    62
    27.4%
    53
    23.5%
    Treatment discontinuations due to AE
    14
    6.2%
    15
    6.6%
    Treatment discontinuations due to blinded study treatment-related AE
    10
    4.4%
    10
    4.4%
    Treatment discontinuations due to CHP treatment-related AE
    8
    3.5%
    7
    3.1%
    7. Secondary Outcome
    Title Incidence of Laboratory Abnormalities
    Description Number of participants who experienced a Grade 3 or higher laboratory toxicity.
    Time Frame Up to 8.28 months

    Outcome Measure Data

    Analysis Population Description
    The Safety Analysis Set includes all patients who receive any amount of brentuximab vedotin or any component of CHOP. Treatment group will be determined using the actual treatment received, regardless of the randomization treatment assignment.
    Arm/Group Title A+CHP CHOP
    Arm/Group Description brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
    Measure Participants 223 226
    Any Chemistry Test
    25
    11.1%
    23
    10.2%
    Alanine Aminotransferase High
    3
    1.3%
    1
    0.4%
    Albumin Low
    2
    0.9%
    3
    1.3%
    Alkaline Phosphatase High
    1
    0.4%
    0
    0%
    Calcium Low
    1
    0.4%
    1
    0.4%
    Glucose High
    8
    3.5%
    6
    2.7%
    Phosphate Low
    4
    1.8%
    3
    1.3%
    Potassium High
    0
    0%
    2
    0.9%
    Potassium Low
    3
    1.3%
    2
    0.9%
    Sodium High
    1
    0.4%
    0
    0%
    Sodium Low
    4
    1.8%
    6
    2.7%
    Urate High
    5
    2.2%
    2
    0.9%
    Any Hematology Test
    68
    30.1%
    78
    34.5%
    Absolute Neutrophil Count Low
    17
    7.5%
    19
    8.4%
    Hemoglobin High
    1
    0.4%
    0
    0%
    Hemoglobin Low
    9
    4%
    13
    5.8%
    Leukocytes Low
    12
    5.3%
    21
    9.3%
    Lymphocytes High
    0
    0%
    1
    0.4%
    Lymphocytes Low
    52
    23%
    61
    27%
    Neutrophils Low
    17
    7.5%
    19
    8.4%
    Platelets Low
    1
    0.4%
    1
    0.4%

    Adverse Events

    Time Frame Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months
    Adverse Event Reporting Description Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
    Arm/Group Title A+CHP CHOP A+CHP Subgroup
    Arm/Group Description brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles Includes only participants in A+CHP arm who were randomized but did not receive treatment.
    All Cause Mortality
    A+CHP CHOP A+CHP Subgroup
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 67/223 (30%) 89/226 (39.4%) 1/3 (33.3%)
    Serious Adverse Events
    A+CHP CHOP A+CHP Subgroup
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 89/223 (39.9%) 90/226 (39.8%) 0/0 (NaN)
    Blood and lymphatic system disorders
    Febrile neutropenia 32/223 (14.3%) 26/226 (11.5%) 0/0 (NaN)
    Neutropenia 8/223 (3.6%) 6/226 (2.7%) 0/0 (NaN)
    Anaemia 1/223 (0.4%) 1/226 (0.4%) 0/0 (NaN)
    Leukopenia 1/223 (0.4%) 3/226 (1.3%) 0/0 (NaN)
    Lymphadenopathy 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Lymphopenia 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Thrombocytopenia 1/223 (0.4%) 1/226 (0.4%) 0/0 (NaN)
    Pancytopenia 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Cardiac disorders
    Atrial fibrillation 1/223 (0.4%) 1/226 (0.4%) 0/0 (NaN)
    Cardiac arrest 1/223 (0.4%) 1/226 (0.4%) 0/0 (NaN)
    Sinus tachycardia 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Supraventricular tachycardia 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Tachycardia 1/223 (0.4%) 2/226 (0.9%) 0/0 (NaN)
    Ventricular fibrillation 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Arrhythmia 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Cardiac failure acute 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Cardiogenic shock 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Eye disorders
    Retinal vein occlusion 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Gastrointestinal disorders
    Diarrhoea 4/223 (1.8%) 3/226 (1.3%) 0/0 (NaN)
    Abdominal pain 1/223 (0.4%) 1/226 (0.4%) 0/0 (NaN)
    Constipation 1/223 (0.4%) 1/226 (0.4%) 0/0 (NaN)
    Duodenal ulcer haemorrhage 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Duodenitis haemorrhagic 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Enterocolitis 1/223 (0.4%) 1/226 (0.4%) 0/0 (NaN)
    Inguinal hernia strangulated 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Intestinal perforation 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Nausea 1/223 (0.4%) 4/226 (1.8%) 0/0 (NaN)
    Upper gastrointestinal haemorrhage 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Vomiting 1/223 (0.4%) 3/226 (1.3%) 0/0 (NaN)
    Colitis 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Gastric ulcer 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Haematemesis 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Intestinal obstruction 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Lower gastrointestinal haemorrhage 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Odynophagia 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Oesophagitis 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Small intestinal obstruction 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Stomatitis 0/223 (0%) 2/226 (0.9%) 0/0 (NaN)
    Subileus 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Ulcerative gastritis 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    General disorders
    Pyrexia 9/223 (4%) 8/226 (3.5%) 0/0 (NaN)
    Asthenia 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Extravasation 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Hyperthermia 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Mucosal inflammation 1/223 (0.4%) 1/226 (0.4%) 0/0 (NaN)
    Non-cardiac chest pain 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Death 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Multiple organ dysfunction syndrome 0/223 (0%) 3/226 (1.3%) 0/0 (NaN)
    Hepatobiliary disorders
    Hepatic function abnormal 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Cholangitis 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Infections and infestations
    Pneumonia 11/223 (4.9%) 3/226 (1.3%) 0/0 (NaN)
    Sepsis 5/223 (2.2%) 4/226 (1.8%) 0/0 (NaN)
    Cellulitis 2/223 (0.9%) 0/226 (0%) 0/0 (NaN)
    Clostridium difficile colitis 2/223 (0.9%) 0/226 (0%) 0/0 (NaN)
    Device related infection 2/223 (0.9%) 0/226 (0%) 0/0 (NaN)
    Influenza 2/223 (0.9%) 0/226 (0%) 0/0 (NaN)
    Neutropenic infection 2/223 (0.9%) 1/226 (0.4%) 0/0 (NaN)
    Pneumocystis jirovecii pneumonia 2/223 (0.9%) 0/226 (0%) 0/0 (NaN)
    Urinary tract infection 2/223 (0.9%) 0/226 (0%) 0/0 (NaN)
    Abscess soft tissue 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Anal fistula infection 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Bacterial pyelonephritis 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Bacterial sepsis 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Bronchopulmonary aspergillosis 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Catheter site cellulitis 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Clostridium difficile infection 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Cytomegalovirus infection 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Enterocolitis infectious 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Epstein-Barr virus infection 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    H1N1 influenza 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Infection 1/223 (0.4%) 1/226 (0.4%) 0/0 (NaN)
    Injection site infection 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Lymph gland infection 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Otitis externa 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Perirectal abscess 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Respiratory syncytial virus infection 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Septic shock 1/223 (0.4%) 2/226 (0.9%) 0/0 (NaN)
    Soft tissue infection 1/223 (0.4%) 1/226 (0.4%) 0/0 (NaN)
    Staphylococcal infection 1/223 (0.4%) 2/226 (0.9%) 0/0 (NaN)
    Erysipelas 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Escherichia sepsis 0/223 (0%) 2/226 (0.9%) 0/0 (NaN)
    Groin abscess 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Laryngitis 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Neutropenic sepsis 0/223 (0%) 3/226 (1.3%) 0/0 (NaN)
    Skin infection 0/223 (0%) 2/226 (0.9%) 0/0 (NaN)
    Staphylococcal sepsis 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Streptococcal sepsis 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Viral upper respiratory tract infection 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Diabetic foot infection 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Injury, poisoning and procedural complications
    Splenic rupture 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Hip fracture 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Spinal compression fracture 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Investigations
    Weight decreased 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    CSF volume decreased 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Metabolism and nutrition disorders
    Tumour lysis syndrome 3/223 (1.3%) 0/226 (0%) 0/0 (NaN)
    Dehydration 2/223 (0.9%) 3/226 (1.3%) 0/0 (NaN)
    Decreased appetite 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Fluid overload 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Hypokalaemia 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Hyperuricaemia 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Hyponatraemia 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Type 2 diabetes mellitus 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Musculoskeletal and connective tissue disorders
    Bone pain 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Pain in extremity 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Muscular weakness 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Vertebral column mass 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Papillary thyroid cancer 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Peripheral T-cell lymphoma unspecified 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Tumour haemorrhage 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Anaplastic large cell lymphoma T- and null-cell types 0/223 (0%) 11/226 (4.9%) 0/0 (NaN)
    Cancer pain 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Metastases to central nervous system 0/223 (0%) 2/226 (0.9%) 0/0 (NaN)
    Transitional cell carcinoma 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Tumour associated fever 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Cutaneous T-cell lymphoma 2/223 (0.9%) 1/226 (0.4%) 0/0 (NaN)
    Myelodysplastic syndrome 1/223 (0.4%) 1/226 (0.4%) 0/0 (NaN)
    Neoplasm malignant 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    T-cell type acute leukaemia 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Nervous system disorders
    Peripheral sensory neuropathy 2/223 (0.9%) 0/226 (0%) 0/0 (NaN)
    Dizziness 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Headache 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Peripheral motor neuropathy 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Seizure 1/223 (0.4%) 1/226 (0.4%) 0/0 (NaN)
    Syncope 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Autonomic neuropathy 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Cerebral infarction 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Hydrocephalus 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Paraesthesia 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Product Issues
    Device issue 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Psychiatric disorders
    Mental status changes 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Confusional state 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Renal and urinary disorders
    Acute kidney injury 3/223 (1.3%) 0/226 (0%) 0/0 (NaN)
    Haematuria 1/223 (0.4%) 1/226 (0.4%) 0/0 (NaN)
    Renal failure 1/223 (0.4%) 1/226 (0.4%) 0/0 (NaN)
    Urinary retention 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Oliguria 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis 5/223 (2.2%) 0/226 (0%) 0/0 (NaN)
    Respiratory failure 3/223 (1.3%) 2/226 (0.9%) 0/0 (NaN)
    Pulmonary embolism 2/223 (0.9%) 6/226 (2.7%) 0/0 (NaN)
    Acute respiratory failure 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Cough 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Dyspnoea 2/223 (0.9%) 0/226 (0%) 0/0 (NaN)
    Haemoptysis 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Pleural effusion 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Pneumonia aspiration 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Pulmonary cavitation 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Acute respiratory distress syndrome 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Skin and subcutaneous tissue disorders
    Rash 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Rash maculo-papular 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Blister 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Vascular disorders
    Deep vein thrombosis 3/223 (1.3%) 2/226 (0.9%) 0/0 (NaN)
    Embolism 1/223 (0.4%) 0/226 (0%) 0/0 (NaN)
    Hypotension 1/223 (0.4%) 1/226 (0.4%) 0/0 (NaN)
    Thrombophlebitis superficial 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Orthostatic hypotension 0/223 (0%) 1/226 (0.4%) 0/0 (NaN)
    Other (Not Including Serious) Adverse Events
    A+CHP CHOP A+CHP Subgroup
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 220/223 (98.7%) 218/226 (96.5%) 0/0 (NaN)
    Blood and lymphatic system disorders
    Neutropenia 87/223 (39%) 81/226 (35.8%) 81/0 (Infinity)
    Anaemia 64/223 (28.7%) 49/226 (21.7%) 49/0 (Infinity)
    Thrombocytopenia 21/223 (9.4%) 14/226 (6.2%) 14/0 (Infinity)
    Leukopenia 18/223 (8.1%) 13/226 (5.8%) 13/0 (Infinity)
    Febrile neutropenia 16/223 (7.2%) 9/226 (4%) 9/0 (Infinity)
    Endocrine disorders
    Hypothyroidism 12/223 (5.4%) 11/226 (4.9%) 11/0 (Infinity)
    Gastrointestinal disorders
    Nausea 114/223 (51.1%) 91/226 (40.3%) 91/0 (Infinity)
    Constipation 98/223 (43.9%) 94/226 (41.6%) 94/0 (Infinity)
    Diarrhoea 93/223 (41.7%) 55/226 (24.3%) 55/0 (Infinity)
    Vomiting 60/223 (26.9%) 37/226 (16.4%) 37/0 (Infinity)
    Stomatitis 28/223 (12.6%) 27/226 (11.9%) 27/0 (Infinity)
    Abdominal pain 26/223 (11.7%) 22/226 (9.7%) 22/0 (Infinity)
    Gastrooesophageal reflux disease 22/223 (9.9%) 16/226 (7.1%) 16/0 (Infinity)
    Abdominal pain upper 23/223 (10.3%) 10/226 (4.4%) 10/0 (Infinity)
    Dyspepsia 17/223 (7.6%) 12/226 (5.3%) 12/0 (Infinity)
    Haemorrhoids 8/223 (3.6%) 12/226 (5.3%) 12/0 (Infinity)
    General disorders
    Fatigue 83/223 (37.2%) 80/226 (35.4%) 80/0 (Infinity)
    Pyrexia 86/223 (38.6%) 74/226 (32.7%) 74/0 (Infinity)
    Oedema peripheral 40/223 (17.9%) 36/226 (15.9%) 36/0 (Infinity)
    Asthenia 35/223 (15.7%) 20/226 (8.8%) 20/0 (Infinity)
    Mucosal inflammation 15/223 (6.7%) 14/226 (6.2%) 14/0 (Infinity)
    Chest pain 14/223 (6.3%) 8/226 (3.5%) 8/0 (Infinity)
    Malaise 8/223 (3.6%) 12/226 (5.3%) 12/0 (Infinity)
    Infections and infestations
    Upper respiratory tract infection 18/223 (8.1%) 12/226 (5.3%) 12/0 (Infinity)
    Nasopharyngitis 10/223 (4.5%) 12/226 (5.3%) 12/0 (Infinity)
    Urinary tract infection 12/223 (5.4%) 9/226 (4%) 9/0 (Infinity)
    Investigations
    Weight decreased 54/223 (24.2%) 43/226 (19%) 43/0 (Infinity)
    Alanine aminotransferase increased 11/223 (4.9%) 0/226 (0%) 0/0 (NaN)
    Metabolism and nutrition disorders
    Decreased appetite 53/223 (23.8%) 47/226 (20.8%) 47/0 (Infinity)
    Hypokalaemia 29/223 (13%) 24/226 (10.6%) 24/0 (Infinity)
    Diabetes mellitus 14/223 (6.3%) 13/226 (5.8%) 13/0 (Infinity)
    Hypercholesterolaemia 10/223 (4.5%) 12/226 (5.3%) 12/0 (Infinity)
    Hyperlipidaemia 9/223 (4%) 13/226 (5.8%) 13/0 (Infinity)
    Hyperglycaemia 11/223 (4.9%) 9/226 (4%) 9/0 (Infinity)
    Hyperuricaemia 11/223 (4.9%) 9/226 (4%) 9/0 (Infinity)
    Musculoskeletal and connective tissue disorders
    Back pain 44/223 (19.7%) 43/226 (19%) 43/0 (Infinity)
    Arthralgia 31/223 (13.9%) 20/226 (8.8%) 20/0 (Infinity)
    Myalgia 27/223 (12.1%) 21/226 (9.3%) 21/0 (Infinity)
    Pain in extremity 23/223 (10.3%) 21/226 (9.3%) 21/0 (Infinity)
    Bone pain 15/223 (6.7%) 12/226 (5.3%) 12/0 (Infinity)
    Neck pain 11/223 (4.9%) 8/226 (3.5%) 8/0 (Infinity)
    Nervous system disorders
    Peripheral sensory neuropathy 112/223 (50.2%) 108/226 (47.8%) 108/0 (Infinity)
    Headache 37/223 (16.6%) 36/226 (15.9%) 36/0 (Infinity)
    Dizziness 32/223 (14.3%) 24/226 (10.6%) 24/0 (Infinity)
    Paraesthesia 13/223 (5.8%) 19/226 (8.4%) 19/0 (Infinity)
    Dysgeusia 13/223 (5.8%) 15/226 (6.6%) 15/0 (Infinity)
    Peripheral motor neuropathy 8/223 (3.6%) 18/226 (8%) 18/0 (Infinity)
    Psychiatric disorders
    Insomnia 52/223 (23.3%) 49/226 (21.7%) 49/0 (Infinity)
    Anxiety 30/223 (13.5%) 13/226 (5.8%) 13/0 (Infinity)
    Depression 16/223 (7.2%) 15/226 (6.6%) 15/0 (Infinity)
    Reproductive system and breast disorders
    Benign prostatic hyperplasia 9/223 (4%) 14/226 (6.2%) 14/0 (Infinity)
    Respiratory, thoracic and mediastinal disorders
    Cough 37/223 (16.6%) 44/226 (19.5%) 44/0 (Infinity)
    Dyspnoea 39/223 (17.5%) 33/226 (14.6%) 33/0 (Infinity)
    Oropharyngeal pain 21/223 (9.4%) 19/226 (8.4%) 19/0 (Infinity)
    Skin and subcutaneous tissue disorders
    Alopecia 58/223 (26%) 56/226 (24.8%) 56/0 (Infinity)
    Night sweats 46/223 (20.6%) 63/226 (27.9%) 63/0 (Infinity)
    Rash 27/223 (12.1%) 21/226 (9.3%) 21/0 (Infinity)
    Pruritus 22/223 (9.9%) 15/226 (6.6%) 15/0 (Infinity)
    Dry skin 10/223 (4.5%) 17/226 (7.5%) 17/0 (Infinity)
    Vascular disorders
    Hypertension 71/223 (31.8%) 68/226 (30.1%) 68/0 (Infinity)
    Hypotension 15/223 (6.7%) 14/226 (6.2%) 14/0 (Infinity)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    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:
    NCT01777152
    Other Study ID Numbers:
    • SGN35-014
    • 2012-002751-42
    First Posted:
    Jan 28, 2013
    Last Update Posted:
    Nov 30, 2021
    Last Verified:
    Nov 1, 2021