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EPCORE™DLBCL-1: A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in R/R DLBCL

Sponsor
Genmab (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04628494
Collaborator
AbbVie (Industry)
480
Enrollment
234
Locations
2
Arms
39.6
Anticipated Duration (Months)
2.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The drug that will be investigated in the study is an antibody, epcoritamab, also known as GEN3013 . Since the safety and tolerability of epcoritamab has already been studied in previous studies in humans, the main purpose of this study is to evaluate efficacy. To evaluate this, half of the participants who are eligible will receive epcoritamab and the other half will receive a pre-specified investigator's choice of chemotherapy. Epcoritamab will be studied in R/R DLBCL participants who did not respond to a previous autologous stem cell transplant (ASCT) or do not meet the criteria for ASCT

Condition or Disease Intervention/Treatment Phase
  • Biological: Epcoritamab
  • Drug: Investigator's Choice Chemotherapy
 Phase 3

Detailed Description

The trial is an open label, multi-center, global phase 3 randomized trial of Epcoritamab, GEN3013. The goal of this randomized trial is to evaluate the efficacy of epcoritamab (GEN3013 DuoBody®-CD3xCD20) compared to investigator's choice of chemotherapy, in patients with relapsed, refractory diffuse large B-Cell Lymphoma who have failed or are ineligible for high-dose chemotherapy and autologous stem cell transplant (HDT-ASCT). No change in chemotherapy is permitted for participants during the treatment phase of the trial.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
480 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open-Label, Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)
Actual Study Start Date :
Jan 13, 2021
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Epcoritamab (GEN3013; DuoBody®CD3xCD20)

Epcoritamab will be administered in Cycles of 28 days until any of the discontinuation criteria is met

Biological: Epcoritamab
Following mandatory pre-medication subject will be administered epcoritamab as a subcutaneous injection.
Other Names:
  • GEN3013; DuoBody®-CD3xCD20

    		•
    Active Comparator: Investigator's choice of chemotherapy

    R-GemOx will be administrated in Cycles of 28 days until maximum cycles completion or any of the discontinuation criteria is met BR will be administrated in Cycles of 21 days until maximum cycles completion or any of the discontinuation criteria is met

    Drug: Investigator's Choice Chemotherapy
    Following mandatory pre-medication subject will be administered intravenously either BR or R-GemOx.
    Other Names:
  • BR or R-GemOx

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall Survival (OS) [throughout the study and up to 2 years following the last patient first dose]

      OS is calculated as the time from first dose to death date or last date known to be alive.

    Secondary Outcome Measures

    1. Progression Free Survival (PFS) [throughout the study and up to 2 years following the last patient first dose]

      PFS is calculated as the time from randomization to the date of disease progression or death, whichever is earlier. Progression is determined by the Lugano criteria and LYRIC.

    2. Overall Response Rate (ORR) [throughout the study and up to 2 years following the last patient first dose]

      ORR is calculated as the proportion of subjects achieving a complete response or partial response. Response is determined by the Lugano criteria and LYRIC.

    3. Complete Response (CR) [throughout the study and up to 2 years following the last patient first dose]

      CR rate is calculated as the proportion of subjects achieving a complete response. Response is determined by the Lugano criteria and LYRIC.

    4. Duration of Response (DOR) [throughout the study and up to 2 years following the last patient first dose]

      DOR is calculated as the time from initial response (CR or PR) to date of progression or death, whichever is earlier. Response and progression are determined by the Lugano criteria and LYRIC.

    5. Time to Response (TTR) [throughout the study and up to 2 years following the last patient first dose]

      TTR is calculated as the time from randomization to date of initial response (CR or PR) among responders only. Response is determined by the Lugano criteria and LYRIC.

    6. Rate and duration of minimal residual disease (MRD) negative status [up to 2 years after randomization of the last patient]

      Compare other measures of efficacy to SOC - MRD negativity rate, defined as the proportion of subjects who have at least one negative MRD sample at any time point prior to start of subsequent anti-lymphoma therapy

    7. Time to next anti-lymphoma therapy (TTNT) [throughout the study and up to 2 years following the last patient first dose]

      TTNT is calculated as the time from randomization to date of initiation of new anti-lymphoma therapy.

    8. Incidence and severity of adverse events (AEs) [throughout the study and up to 2 years following the last patient first dose]

      identify patterns of incidence in adverse events, with particular emphasis on pre-defined adverse events of special interest

    9. Incidence and severity of changes in laboratory values [throughout the study and up to 2 years following the last patient first dose]

      Clinical laboratory parameters assessed: hematology, chemistry, coagulation, tumor lysis, immunoglobulins, and urinalyses

    10. Incidence of dose interruptions and delays [throughout the study and up to 2 years following the last patient first dose]

      calculate incidence and present the occurrence of dose modifying toxicities by cycles and overall

    11. Anti-epcoritamab antibody response [throughout the study and up to 2 years following the last patient first dose]

      calculate incidence of antibody response to epcoritamab in relation to dosing

    12. Changes in lymphoma symptoms as measured by the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) [throughout the study and up to 2 years following the last patient first dose]

      monitor change from baseline in health-related quality of life over time and in relation to treatment

    Eligibility Criteria

    Criteria

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

    1. Relapsed or refractory disease and previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy since lymphoma diagnosis

    2. One of the confirmed histologies below with CD20-positivity:

    3. DLBCL, NOS, including de novo or histologically transformed from FL

    4. "Double-hit" or "triple-hit" DLBCL (technically classified in WHO 2016 as HGBCL, with MYC and BCL2 and/or BCL6 translocations), including de novo or histologically transformed from FL

    5. FL Grade 3B

    6. T-cell/histiocyte-rich large B-cell lymphoma

    7. ECOG PS score of 0-2

    8. Failed previous HDT-ASCT or not eligible for HDT-ASCT at screening

    9. Patients must have detectable disease by PET scan and measurable by CT scan or MRI

    10. Acceptable renal and liver function

    11. Life expectancy >2 months on SOC treatment

    Main Exclusion Criteria:

    1. Primary Central Nervous System (CNS) tumor or known CNS involvement

    2. Any prior therapy with a bispecific antibody targeting CD3 and CD20

    3. Major surgery within 4 weeks prior to randomization

    4. Chemotherapy and other non-investigational antineoplastic agents (except CD20 mAbs) within 4 weeks or 5 half-lives (whichever is shorter) prior to randomization

    5. Any investigational drug within 4 weeks or 5 half-lives, whichever is longer, prior to randomization

    6. ASCT within 100 days of randomization

    7. Treatment with CAR-T therapy within 100 days prior to randomization

    8. Seizure disorder requiring anti-epileptic therapy

    9. Clinically significant cardiac disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UC Irvine Irvine California United States 92697
    2 Indiana Blood and Marrow Transplantation Indianapolis Indiana United States 46237
    3 Community Health Network Cancer Center North Indianapolis Indiana United States 46250
    4 University of Kentucky Markey Cancer Center Lexington Kentucky United States 40536
    5 Ochsner Medical Center New Orleans Louisiana United States 70121
    6 Henry Ford Health System Jackson Michigan United States 49201
    7 MMCORC Attn Delaney Anderson Saint Louis Park Minnesota United States 55416
    8 MD Anderson Cancer Center at Cooper Camden New Jersey United States 08103
    9 Wake Forest Baptist Health Winston-Salem North Carolina United States 27157
    10 The Christ Hospital Cancer Center Cincinnati Ohio United States 45229
    11 TriHealth Cancer Institute- Good Samaritan Hospital Cincinnati Ohio United States 45247
    12 University of Tennessee Medical Center Knoxville Tennessee United States 37920
    13 Baptist Cancer Center Memphis Tennessee United States 38120
    14 Brooke Army Medical Center Fort Sam Houston Texas United States 78234
    15 Community Cancer Trials of Utah Ogden Utah United States 84405
    16 LDS Hospital Salt Lake City Utah United States 84143
    17 North Star Lodge Cancer Center Yakima Washington United States 98902
    18 Waukesha Memorial Hospital Waukesha Wisconsin United States 53188
    19 Flinders Medical Centre Bedford Park Australia
    20 Concord Repatriation General Hospital Concord Australia
    21 St Vincents Hospital Sydney Darlinghurst Australia
    22 Peninsula Private Hospital Clinical Trials Unit Frankston Australia
    23 Icon Cancer Centre Corporate Office South Brisbane Australia
    24 Calvary Mater Newcastle Waratah Australia
    25 Westmead Hospital Westmead Australia
    26 Medical University of Graz, Division of Hematology Graz Austria
    27 Ordensklinikum Linz Barmherzige Schwestern Linz Austria
    28 Ordensklinikum Linz GmbH Elisabethinen Linz Austria
    29 Uniklinikum Salzburg, Universitätsklinik für Innere Medizin III der PMU Salzburg Austria
    30 ZNA Middelheim Antwerp Belgium
    31 AZ Sint-Jan Brugge Belgium
    32 Institut Jules Bordet Brussels Belgium
    33 Universitair Ziekenhuis Gent Gent Belgium
    34 UZ Brussel Jette Belgium
    35 AZ Groeninge Kortrijk Belgium
    36 Hôpital de Jolimont La Louvière Belgium
    37 Universitair Ziekenhuis gasthuisberg Leuven Leuven Belgium
    38 AZ Delta Menen Belgium
    39 AZ Nikolaas- Verenigde Ziekenhuizen van Waas en Durme Sint-Niklaas Belgium
    40 AZ Turnhout, Campus Sint-Elisabeth Turnhout Belgium
    41 Cliniques Universitaires Saint-Luc Woluwe-Saint-Lambert Belgium
    42 Grand River Hospital Kitchener Canada
    43 McGill University Health Centre Montréal Canada
    44 CHU de Quebec-Universite Laval Québec City Canada
    45 Research And Innovation Saint John's Canada
    46 Aalborg Universitetshospital Aalborg Denmark
    47 Aarhus University Hospital, Department of Hematology, Clinical Research Unit C116 Aarhus Denmark
    48 Clinical Research Unit, KFE Herlev Hospital Herlev Denmark
    49 Vejle Hospital Vejle Denmark
    50 HUS Cancer Center/ Clinical Trial Unit Helsinki Finland
    51 Kuopio University Hospital Cancer Center Kuopio Finland
    52 Oulu university hospital, Department of hematology Oulu Finland
    53 Tampere University Hospital Tampere Finland
    54 Turku University Hospital, Oncology department Turku Finland
    55 Audrey ALEME Amiens France
    56 Centre Hospitalier de la Côte Basque Bayonne France
    57 CHRU de Brest - Hospital Morvan Brest France
    58 CHU Caen - IHBN Caen France
    59 CHU de Dijon Hôpital du Bocage Dijon France
    60 Groupe Hospitalier de La Rochelle La Rochelle France
    61 CHU de LIMOGES Limoges France
    62 Centre Léon Bérard Lyon France
    63 Hopital de la Conception APHM Marseille France
    64 CHU de Nantes - Hôtel Dieu Nantes France
    65 Centre Antoine Lacassagne Nice France
    66 Clinique Victor Hugo Paris France
    67 Hôpital Saint-Louis Paris France
    68 CHU de Bordeaux Hôpital Haut-Lévêque Pessac France
    69 Centre Hospitalier Lyon Sud Pierre-Bénite France
    70 CHU de Poitiers - Hôpital la Milétrie Poitiers France
    71 Centre Hospitalier Rene Dubos Pontoise France
    72 Ch Cornouaille Quimper France
    73 Centre Henri Becquerel Rouen France
    74 CHRU Tours Hôpital Bretonneau Tours France
    75 Vivantes Klinikum Am Urban Berlin Germany
    76 Uniklinik Köln, Klinik I für Innere Medizin, CIO Gebäude 70, 5.094 Cologne Germany
    77 Universitaetsklinikum Essen Essen Germany
    78 Universitätsklinikum Schleswig-Holstein Medizinische Klinik II Hämatologie und Onkologie Kiel Germany
    79 National Institute of Oncology Budapest Hungary
    80 Semmelweis Egyetem Belgyógyászati és Onkológiai Klinika Budapest Hungary
    81 Semmelweis Egyetem, Belgyógyászati és Hematológiai Klinika Budapest Hungary
    82 Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Hematologia Debrecen Hungary
    83 Belgyógyászati osztály Markhot Ferenc Kórház Eger Hungary
    84 Petz Aladar Egyetemi Oktato Korhaz Győr Hungary
    85 Somogy Megyei Kaposi Mor Oktato Korhaz Kaposvár Hungary
    86 Josa Andras Teaching Hospital, Hematology Dept Nyiregyhaza Hungary
    87 University of Pecs 1st. Internal medicine Clinic Dept. Hematology Pécs Hungary
    88 Szegedi Tudományegyetem II. sz. Belgyogyaszat, Hematologia Szeged Hungary
    89 Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz Szekesfehervar Hungary
    90 Szent Borbala Hospital, Hematology Department Tatabánya Hungary
    91 Soroka Medical Center Beersheba Israel
    92 Bnai Zion Medical Center Haifa Israel
    93 Rambam Health Care Center Haifa Israel
    94 Hadassah University Hospital Jerusalem Israel
    95 Shaare Zedek Medical Center Jerusalem Israel
    96 Laniado Medical Center Netanya Israel
    97 Sourasky Medical Center Tel Aviv Israel
    98 Sheba Medical Center Tel HaShomer Israel
    99 IRCCS Istituto Tumori Giovanni Paolo II Bari Bari Italy
    100 Azienda Socio Sanitaria Territoriale Sette Laghi (Presidio Ospedale di Circolo e Fondazione Macchi) Bergamo Italy
    101 AOU Policlinico Sant Orsola Malpighi Bologna Italy
    102 Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) Brescia Italy
    103 Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) Meldola Italy
    104 ASST Niguarda (Grande Ospedale Metropolitano Niguarda), S.C. Ematologia - Dipartimento di Ematologia Milano Italy
    105 Istituto Oncologico Europeo Milan Italy
    106 San Raffaele Hospital Milan Italy
    107 Azienda Ospedaliero - Universitaria Maggiore delle Carita SCDU Ematologia building C Novara Italy
    108 Fondazione IRCCS Policlinico San matteo Pavia Italy
    109 Ospedale Santa Maria delle Croci Ravenna Italy
    110 IRCCS Ospedale Casa Sollievo della Sofferenza San Giovanni Rotondo Italy
    111 SC Ematologia - AOU Città della Salute e della Scienza di Torino Turin Italy
    112 SC di Ematologia - AON SS Antonio e Biagio e Cesare Arrigo Venezia Italy
    113 Kyushu University Hospital Fukuoka Japan
    114 Fukushima Medical University Hospital Fukushima Japan
    115 Chugoku Central Hospital Fukuyama Japan
    116 Hokkaido University Hospital Hokkaido Japan
    117 National Cancer Center Hospital East Kashiwa Japan
    118 Kyoto University Medical Hospital Kyoto Japan
    119 Matsuyama Red Cross Hospital Matsuyama Japan
    120 Mie University Hospital Mie Japan
    121 Japanese Red Cross Nagoya Daini Hospital Nagoya Japan
    122 Nagoya City University Hospital Nagoya Japan
    123 NHO Nagoya Medical Center Nagoya Japan
    124 Okayama University Hospital Okayama Japan
    125 Saitama Medical University Hospital Saitama Japan
    126 Tohoku University Hospital Sendai Japan
    127 Osaka University Hospital Suita Japan
    128 Keio University Hospital Tokyo Japan
    129 National Cancer Center Hospital Tokyo Japan
    130 Tokai University Hospital Tokyo Japan
    131 Tokyo Medical University Hospital Tokyo Japan
    132 Fujita Health University Hospital Toyoake Japan
    133 Yamagata University Hospital Yamagata Japan
    134 Kindai University Hospital Ōsaka-sayama Japan
    135 Dong-A University Hospital Busan Korea, Republic of
    136 Pusan National University Hospital Busan Korea, Republic of
    137 Pusan National University Hosptial Busan Korea, Republic of
    138 Keimyung University Dongsan Hospital Daegu Korea, Republic of
    139 Chonbuk National University Hospital Geumam Korea, Republic of
    140 Asan Medical Center Seoul Korea, Republic of
    141 Samsung Medical Center Seoul Korea, Republic of
    142 Seoul National University Bundang Hospital Seoul Korea, Republic of
    143 Seoul National University Hospital Seoul Korea, Republic of
    144 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of
    145 The Catholic University of Korea Seoul St. Marys Hospital Seoul Korea, Republic of
    146 Ulsan University Hospital Ulsan Korea, Republic of
    147 Apotheek Jeroen Bosch Ziekenhuis 's-Hertogenbosch Netherlands
    148 Rijnstate Arnhem Arnhem Netherlands
    149 Amphia Ziekenhuis, Interne Geneeskunde, Oncologie. Route 43 Breda Netherlands
    150 Albert Schweitzer Ziekenhuis Dordrecht Netherlands
    151 Admiraal de Ruyter Ziekenhuis Goes Netherlands
    152 Spaarne Gasthuis Haarlem Netherlands
    153 Haaglanden Medisch Centrum Hague Netherlands
    154 Bravis Ziekenhuis Roosendaal Netherlands
    155 Erasmus MC Rotterdam Netherlands
    156 Franciscus Gasthuis And Vlietland Rotterdam Netherlands
    157 Diakonessenhuis Utrecht Netherlands
    158 Oslo University Hospital location Radium hospital Oslo Norway
    159 St. Olavs Hospital HF Trondheim Norway
    160 Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii Gdańsk Poland
    161 Pratia Onkologia Katowice Katowice Poland
    162 Pratia MCM Kraków Kraków Poland
    163 SP ZOZ MSWiA z WMCO w Olsztynie Olsztyn Poland
    164 Provincial Hospital in Opole sp. Z o.o Department of Hematology, Hematological Oncology and Internal Opole Poland
    165 Centrum Medyczne Pratia Poznan Skorzewo Poland
    166 Wojewodzki Szpital Specjalistyczny w Slupsku Sp z o.o Oddzial Hematologiczny Słupsk Poland
    167 Nasz Lekarz Przychodnie Medyczne Toruń Poland
    168 Department of Internal Medicine and Hematology, Military Institute of Medicine Warsaw Poland
    169 Maria Sklodowska Curie National Oncology Institute State Research Institute Warszawa Poland
    170 Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu Wrocław Poland
    171 Instytut Centrum Zdrowia Matki Polki Łódź Poland
    172 Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii Łódź Poland
    173 State Autonomous Institution of Healthcare Republican Clinical Oncological Dispensary of the Ministr Kazan Russian Federation
    174 State Budgetary Institution of Healthcare Leningrad Regional Clinical Hospital Leningrad Russian Federation
    175 Federal State Budgetary Institution of Science Moscow Russian Federation
    176 Federal State Budgetary Institution Moscow Russian Federation
    177 State Budgetary Institution of Healthcare of Moscow City Clinical Hospital named after S.P. Botkin o Moscow Russian Federation
    178 State Budgetary Institution of Healthcare of Republic Kareliya Republican Hospital named after V.A Moscow Russian Federation
    179 State Budgetary Institution of Healthcare of Nizhniy Novgorod region, 1st inpatient facility, 5th fl Nizhny Novgorod Russian Federation
    180 Federal State Budgetary Institution V.A. Almazov National Medical Research Center of the Ministry of Saint Petersburg Russian Federation
    181 St.-Petersburg Pavlov State Medical University Saint Petersburg Russian Federation
    182 State Institution of Healthcare of Tula Region Tula Regional Clinical Hospital Tula Russian Federation
    183 National University Hospital Kent Ridge Singapore
    184 Clinical Trials and Research Centre Singapore Singapore
    185 National Cancer Centre Singapore Singapore Singapore
    186 ICO Badalona - Hospital Universitari Germans Trias i Pujol Badalona Spain
    187 Hospital Universitari Vall d'Hebron Barcelona Spain
    188 ICO l'Hospitalet - Hospital Duran i Reynals Barcelona Spain
    189 Hospita Universitario Puerta Del Mar Cadiz Spain
    190 Hospital San Pedro de Alcántara Cáceres, Spain
    191 Hospital San Pedro de Alcántara Cáceres Spain
    192 Hospital Universitario Reina Sofía Córdoba Spain
    193 Hospital Arnau de Vilanova Lleida Spain
    194 Hospital Universitario 12 de Octubre Madrid Spain
    195 Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
    196 Hospital Universitario Infanta Leonor Madrid Spain
    197 Hospital Universitario Ramon y Cajal Madrid Spain
    198 Md Anderson Cancer Center Madrid Spain
    199 Hospital Universitario de Salamanca Salamanca Spain
    200 Hospital Universitario Marqués de Valdecilla Santander Spain
    201 Hospital Universitario Virgen De Valme Sevilla Spain
    202 Hospital Universitario Virgen del Rocío Sevilla Spain
    203 Hospital Universitario Virgen Macarena Sevilla Spain
    204 Södra Älvsborgs Sjukhus, Hematolog dagvård Borås Sweden
    205 Sahlgrenska Universitetssjukhuset Gothenburg Sweden
    206 Skåne University Hospital Malmö Sweden
    207 Karolinska university Hospital Stockholm Sweden
    208 Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung Taiwan
    209 National Cheng Kung University Hospital Tainan Taiwan
    210 National Taiwan University Hospital Taipei Taiwan
    211 Taipei Veterans General Hospital Taipei Taiwan
    212 Tri-Service General Hospital Taipei Taiwan
    213 Ankara University Medical Faculty Ankara Turkey
    214 Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi Ankara Turkey
    215 Gazi University Medical Faculty Ankara Turkey
    216 Amerikan Hospital Istanbul Turkey
    217 Iqvia Tibbi Istatistik Istanbul Turkey
    218 Istanbul University Cerrahpasa - Cerrahpasa Tip Fakultesi Istanbul Turkey
    219 Istanbul University Medical Faculty Istanbul Turkey
    220 Dokuz Eylul University Medical Faculty İzmir Turkey
    221 Ege University Medical Faculty İzmir Turkey
    222 Tekirdag Namik Kemal University Tekirdağ Turkey
    223 Karadeniz Technical University Trabzon Turkey
    224 Haematology - University Hospitals Birmingham NHS Foundation Trust Birmingham United Kingdom
    225 Guys and St Thomas NHS Foundation Trust London United Kingdom
    226 Hammersmith Hospital London United Kingdom
    227 The Christie NHS Foundation Trust Manchester United Kingdom
    228 Norfolk and Norwich University Hospitals NHS Foundation Trust Norwich United Kingdom
    229 Nottingham University Hospitals NHS Trust Nottingham United Kingdom
    230 Derriford Hospital Plymouth United Kingdom
    231 University Hospital Southampton Southampton United Kingdom
    232 Royal Marsden NHS Foundation Trust (Sutton) Sutton United Kingdom
    233 Royal Cornwall Hospital Truro United Kingdom
    234 Royal Wolverhampton Nhs Trust, New Cross Hospital Wolverhampton United Kingdom

    Sponsors and Collaborators

    • Genmab
    • AbbVie

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Genmab
    ClinicalTrials.gov Identifier:
    NCT04628494
    Other Study ID Numbers:
    • GCT3013-05
    • 2020-003016-27
    • jRCT2021220017
    First Posted:
    Nov 13, 2020
    Last Update Posted:
    Aug 17, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Genmab
    double-hit DLBCL
    triple-hit DLBCL
    follicular grade 3B
    transformed DLBCL
    T-cell histiocytes-rich large B cell lymphoma
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, B-Cell
    Lymphoma, Large B-Cell, Diffuse

    Study Results

    No Results Posted as of Aug 17, 2022