Back to resultsA Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) (EPCORE DLBCL-2)
Primary Purpose
Diffuse Large B-Cell Lymphoma
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Epcoritamab
Cyclophosphamide
Rituximab
Vincristine
Doxorubicin
Prednisone
Sponsored by
About this trial
This is an interventional treatment trial for Diffuse Large B-Cell Lymphoma focused on measuring Relapsed or Refractory Diffuse Large B-Cell Lymphoma, Non-Hodgkins Lymphoma, Cancer, Epcoritamab, ABBV-GMAB-3013, R-CHOP, Rituximab, EPCORE
Eligibility Criteria
Inclusion Criteria:
- Planned to receive treatment with 6 cycles of standard rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) per investigator determination.
Must have newly diagnosed, histologically confirmed CD20+ diffuse large b-cell lymphoma [DLBCL] (de novo or histologically transformed from a diagnosis of follicular lymphoma) at most recent representative tumor biopsy based on the pathology report, with a World Health Organization (WHO) 2016 classification and including:
- DLBCL, Not Otherwise Specified (NOS).
- High grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangement with DLBCL morphology.
- T-cell/histiocyte-rich large B-cell lymphoma.
- Epstein Barr virus-positive DLBCL, NOS.
- Follicular lymphoma Grade 3b.
Note: The local pathology report must be available at Screening to support CD20+ DLBCL histology.
Composite/intermediate histology with any of the following components is not allowed: high grade B-cell lymphoma, NOS; Hodgkin's lymphoma; primary mediastinal (thymic) large B-cell lymphoma; Burkitt; plasmablastic lymphoma or any CD20- lymphoma, such as anaplastic lymphoma kinase-positive large B-cell lymphoma, human herpesvirus type 8-positive DLBCL, or primary effusion lymphoma.
- Availability of archival or freshly collected tumor tissue at Screening. Archival paraffin-embedded tissue must be obtained within 8 weeks prior to Cycle 1 Day 1.
- Must have an IPI score of 2-5. The number of participants with IPI 2 will be capped at 35% of the overall sample size.
- Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 prior to initiating R-CHOP treatment. Note that participant with an initial ECOG performance status >= 3 may be screened if pre-phase treatment is planned. Participant may be eligible if ECOG performance status were to improve to 0-2 during pre-phase treatment.
Has at least one target lesion defined as:
- >= 1 measurable nodal lesion (long axis > 1.5 cm ) or >= 1 measurable extra-nodal lesion (long axis > 1 cm) on computed tomography (CT) scan or MRI. AND
- Positron emission tomography (PET)-positive on PET-CT scan.
- Laboratory values meeting the criteria laid out in the protocol.
- Left ventricular ejection fraction must be >= 50% by multi-gated acquisition or transthoracic echocardiography at Screening.
Exclusion Criteria:
- History of prior systemic anti-lymphoma therapy for diagnosed diffuse large b-cell lymphoma (DLBCL) including any definitive radiotherapy with curative intent] other than corticosteroids with or without vincristine during prephase treatment, or non-curative intent palliative radiotherapy with the stipulation that radiated lesions cannot be selected as target lesion for response assessment.
- Clinically significant cardiovascular disease as per the protocol.
Sites / Locations
- Millennium Research & Clinical Development /ID# 228284Recruiting
- Liverpool Hospital /ID# 230072Recruiting
- Royal Adelaide Hospital /ID# 225683Recruiting
- Austin Health /ID# 225716Recruiting
- Alfred Health /ID# 225999Recruiting
- Monash Medical Centre /ID# 225680Recruiting
- Hollywood Private Hospital /ID# 251837Recruiting
- Perth Blood Institute Ltd /ID# 225679Recruiting
- Royal Perth Hospital /ID# 226583Recruiting
- Universitaetsklinikum St. Poelten /ID# 234016Recruiting
- Medizinische Universitaet Wien /ID# 252095Recruiting
- Klinik Ottakring /ID# 243941Recruiting
- Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 228360Recruiting
- CHU UCL Namur - site Godinne /ID# 225742Recruiting
- UZ Gent /ID# 250031Recruiting
- AZ-Delta /ID# 225736Recruiting
- Institut Jules Bordet /ID# 225954Recruiting
- Pôle Hospitalier Jolimont /ID# 225738Recruiting
- Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 225952Recruiting
- Vitaz /Id# 226153Recruiting
- Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 226065Recruiting
- Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 226809Recruiting
- Real e Benemérita Associação Portuguesa de Beneficência /ID# 226023Recruiting
- Hospital Alemao Oswaldo Cruz /ID# 252833Recruiting
- Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 226048Recruiting
- UMHAT Sveti Georgi /ID# 245780Recruiting
- Acibadem City Clinic Tokuda University Hospital EAD /ID# 244616Recruiting
- UMHAT Sveti Ivan Rilski /ID# 244615Recruiting
- SHAT Hematologic Diseases /ID# 250102Recruiting
- Beijing Cancer Hospital /ID# 229819Recruiting
- Peking University Third Hospital /ID# 230975Recruiting
- Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 234152Recruiting
- The First Affiliated Hospital of Nanchang University /ID# 230399Recruiting
- Shandong Cancer Hospital /ID# 233200Recruiting
- Clinical Hospital Dubrava /ID# 251809Recruiting
- Klinicka bolnica Merkur /ID# 252481Recruiting
- Klinicki bolnicki centar Zagreb /ID# 250709Recruiting
- Klinicki bolnicki centar Rijeka /ID# 251811Recruiting
- Klinicki bolnicki centar Split /ID# 250729
- Opca bolnica Dr. Josip Bencevic /ID# 251812Recruiting
- Fakultni Nemocnice Brno /ID# 225953Recruiting
- Fakultni nemocnice Hradec Kralove /ID# 225955Recruiting
- Fakultni nemocnice Ostrava /ID# 225957Recruiting
- Rigshospitalet /ID# 226576Recruiting
- Zealand University Hospital, Roskilde /ID# 226597Recruiting
- Odense University Hospital /ID# 226593Recruiting
- Sygehus Lillebalt, Vejle /ID# 226592Recruiting
- CHU de Nice - Hôpital Archet 1 /ID# 226127Recruiting
- HCL - Hopital Lyon Sud /ID# 227086Recruiting
- Institut Paoli-Calmettes /ID# 226557Recruiting
- CHU de Rennes - PONTCHAILLOU /ID# 228207Recruiting
- CHU Dijon /ID# 238345Recruiting
- CHU Limoges - Dupuytren 1 /ID# 234235Recruiting
- CHRU Lille - Hopital Claude Huriez /ID# 226101Recruiting
- CHU Montpellier - Hôpital Saint Eloi /ID# 228191Recruiting
- CHU de Nantes, Hotel Dieu -HME /ID# 226125Recruiting
- Centre Hospitalier de la Cote Basque /ID# 249143Recruiting
- CHU Amiens-Picardie Site Sud /ID# 238347Recruiting
- Chu Angers /Id# 245931Recruiting
- CHU de CAEN - Hopital de la Cote de Nacre /ID# 226582Recruiting
- Hopital Henri Mondor /ID# 226560Recruiting
- CHU Grenoble - Hopital Michallon /ID# 226128Recruiting
- AP-HP - Hopital Saint-Louis /ID# 226126Recruiting
- General Hospital of Athens Laiko /ID# 225399Recruiting
- Alexandra General Hospital /ID# 225402Recruiting
- University General Hospital Attikon /ID# 225401Recruiting
- General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 225416Recruiting
- University General Hospital of Ioannina /ID# 225400Recruiting
- General University Hospital of Thessaloniki AXEPA /ID# 225398Recruiting
- Theageneio Anticancer Hospital /ID# 225516Recruiting
- Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 245938Recruiting
- Markusovszky Egyetemi Oktatokorhaz /ID# 226846Recruiting
- Semmelweis Egyetem /ID# 227239Recruiting
- Orszagos Onkologiai Intezet /ID# 227294Recruiting
- Tolna Megyei Balassa Janos Korhaz /ID# 250063Recruiting
- Assuta Tel Aviv Medical Center /ID# 226066Recruiting
- The Chaim Sheba Medical Center /ID# 225600Recruiting
- Tel Aviv Sourasky Medical Center /ID# 225891Recruiting
- Hadassah /ID# 225614Recruiting
- Meir Medical Center /ID# 225612Recruiting
- Rabin Medical Center /ID# 225862Recruiting
- IEO -Istituto Europeo di Oncologia /ID# 225545Recruiting
- Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 225751Recruiting
- Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo /ID# 225542Recruiting
- ASST Spedali civili di Brescia /ID# 225549Recruiting
- Azienda Ospedaliera Universitaria Federico II /ID# 225543Recruiting
- Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 225773Recruiting
- A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 225541Recruiting
- Ospedale Santa Maria delle Croci /ID# 225571Recruiting
- NHO Nagoya Medical Center /ID# 230677Recruiting
- Aichi Cancer Center Hospital /ID# 226090Recruiting
- National Cancer Center Hospital East /ID# 250151Recruiting
- Matsuyama Red Cross Hospital /ID# 251068Recruiting
- National Hospital Organization Kyushu Cancer Center /ID# 251622Recruiting
- Kyushu University Hospital /ID# 226091Recruiting
- Fukushima Medical University Hospital /ID# 250869Recruiting
- Hokkaido University Hospital /ID# 250149Recruiting
- Kobe City Medical Center General Hospital /ID# 250597Recruiting
- University of Tsukuba Hospital /ID# 251282Recruiting
- Kanazawa University Hospital /ID# 251770Recruiting
- Kagoshima University Hospital /ID# 250163Recruiting
- Tokai University Hospital /ID# 251281Recruiting
- Tohoku University Hospital /ID# 250150Recruiting
- Okayama University Hospital /ID# 250161Recruiting
- Kindai University Hospital /ID# 250160Recruiting
- Osaka University Hospital /ID# 251283Recruiting
- National Cancer Center Hospital /ID# 226089Recruiting
- The Cancer Institute Hospital Of JFCR /ID# 230269Recruiting
- Yamagata University Hospital /ID# 230003Recruiting
- Seoul National University Bundang Hospital /ID# 225763Recruiting
- Inje University Busan Paik Hospital /ID# 232262Recruiting
- Dong-A University Hospital /ID# 228451Recruiting
- Keimyung University Dongsan Medical Center /ID# 232264Recruiting
- Jeonbuk National University Hospital /ID# 232263Recruiting
- Seoul National University Hospital /ID# 225760Recruiting
- Asan Medical Center /ID# 225758Recruiting
- Samsung Medical Center /ID# 225759Recruiting
- The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 225761Recruiting
- Ulsan University Hospital /ID# 226971Recruiting
- Flevoziekenhuis /ID# 229606Recruiting
- Gelre Ziekenhuizen /ID# 229762Recruiting
- Tergooi /ID# 229772Recruiting
- Zaans Medisch Centrum /ID# 230614Recruiting
- Albert Schweitzer Ziekenhuis /ID# 229560Recruiting
- Noordwest Ziekenhuisgroep /ID# 230613Recruiting
- Meander Medisch Centrum /ID# 229608Recruiting
- Vrije Universiteit Medisch Centrum /ID# 225608Recruiting
- Onze Lieve Vrouwe Gasthuis /ID# 229761Recruiting
- Amphia Ziekenhuis /ID# 229550Recruiting
- Haaglanden Medisch Centrum /ID# 229686Recruiting
- Deventer Ziekenhuis /ID# 229937Recruiting
- Catharina Ziekenhuis /ID# 230465Recruiting
- Maxima Medisch Centrum /ID# 225603Recruiting
- Medisch Spectrum Twente /ID# 225610Recruiting
- Universitair Medisch Centrum Groningen /ID# 225602Recruiting
- Medisch Centrum Leeuwarden /ID# 225605Recruiting
- St. Antonius Ziekenhuis /ID# 229901Recruiting
- Canisius-Wilhelmina Ziekenhuis /ID# 231291Recruiting
- Jeroen Bosch Ziekenhuis /ID# 229765Recruiting
- Elisabeth Tweesteden Ziekenhuis /ID# 229773Recruiting
- Diakonessenhuis /ID# 251793Recruiting
- North Shore Hospital /ID# 250992Recruiting
- Christchurch Hospital /ID# 250993Recruiting
- Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka /ID# 228723Recruiting
- Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 225986Recruiting
- SP ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii /ID# 225985Recruiting
- ARS-MEDICAL Sp. z o.o. /ID# 225848Recruiting
- Centrum Medyczne Pratia Poznan /ID# 227236Recruiting
- CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 225809Recruiting
- Hospital Parc de Salut del Mar /ID# 225810Recruiting
- Hospital Universitario Vall d'Hebron /ID# 225811Recruiting
- Hospital Clinic de Barcelona /ID# 226651Recruiting
- Hospital Santa Creu i Sant Pau /ID# 225813Recruiting
- Hospital Universitario Reina Sofia /ID# 225806Recruiting
- CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 228228Recruiting
- Hospital Universitario Infanta Leonor /ID# 225816Recruiting
- MD Anderson Madrid /ID# 225817Recruiting
- Hospital Universitario Ramon y Cajal /ID# 241750Recruiting
- Hospital Universitario Fundacion Jimenez Diaz /ID# 225804Recruiting
- Hospital Universitario 12 de Octubre /ID# 225815Recruiting
- Hospital Clinico Universitario de Valencia /ID# 225818Recruiting
- Sodra Alvsborgs sjukhus /ID# 228885Recruiting
- Linkoping University Hospital /ID# 233521Recruiting
- Kantonsspital Aarau AG /ID# 229112Recruiting
- Spital Thun /ID# 229499Recruiting
- Kaohsiung Chang Gung Memorial Hospital /ID# 226670Recruiting
- China Medical University Hospital /ID# 226188Recruiting
- Taichung Veterans General Hospital /ID# 226674Recruiting
- National Cheng Kung University Hospital /ID# 226671Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Epcoritamab and R-CHOP
R-CHOP and Rituximab
Arm Description
Participants will receive subcutaneous epcoritamab combined with intravenous and oral rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) followed by epcoritamab in 21-day cycles.
Participants will receive intravenous and oral R-CHOP followed by intravenous rituximab in 21-day cycles.
Outcomes
Primary Outcome Measures
Number of Participants with Progression-Free Survival (PFS) with an International Prognostic Index (IPI) of 3-5
PFS is defined as the duration from randomization to the date of disease progression as determined by Lugano 2014 criteria as assessed by Independent Review Committee (IRC), or death due to any cause whichever comes first.
Secondary Outcome Measures
Number of Participants with PFS
PFS is defined as the duration from randomization to the date of disease progression as determined by Lugano 2014 criteria as assessed by IRC, or death due to any cause, whichever occurs first.
Number of Participants with Event-free survival (EFS)
EFS is defined as the duration from randomization to the date of disease progression determined by Lugano criteria as assessed by IRC, IRC-assessed PR or SD followed by non protocol-specified NALT, a positive biopsy on or after end-of-treatment (EOT), regardless of whether NAL initiated, or death from any cause.
Percentage of Participants with Complete Remission (CR)
CR is defined as the absence of lymphoma determined by fluorodeoxyglucose positron emission tomography (FDG-PET),determined by Lugano 2014 criteria as assessed by IRC.
Overall survival (OS)
OS is defined as time from randomization until death due to any causes.
Percentage of Participants with Minimal Residual Disease (MRD) Negativity
The MRD negativity rate is defined as the percentage of participants who achieve MRD negativity prior to the initiation of any non-protocol-specified new anti-lymphoma therapy.
Full Information
NCT ID
NCT05578976
First Posted
October 12, 2022
Last Updated
October 23, 2023
Sponsor
AbbVie
Collaborators
Genmab
1. Study Identification
Unique Protocol Identification Number
NCT05578976
Brief Title
A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)
Acronym
EPCORE DLBCL-2
Official Title
A Phase 3, Randomized, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With R-CHOP Compared to R-CHOP in Subjects With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2023 (Actual)
Primary Completion Date
January 31, 2027 (Anticipated)
Study Completion Date
June 11, 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
Collaborators
Genmab
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The purpose of this study is to assess the change in disease activity of epcoritamab when combined with intravenous and oral rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) or R-CHOP in adult participants globally with diffuse large b-cell lymphoma (DLBCL). Change in disease activity will be assessed.
Epcoritamab is an investigational drug being developed for the treatment of DLBCL. Study doctors put the participants in groups called treatment arms. Participants will receive epcoritamab combined with R-CHOP, followed by epcoritamab or R-CHOP followed by rituximab will be explored. Approximately 900 adult participants with with newly diagnosed DLBCL will be enrolled in the study in approximately 315 sites in globally.
In the Arm 1, participants will receive subcutaneous epcoritamab combined with intravenous and oral R-CHOP followed by subcutaneous epcoritamab in 21-day cycles. In the Arm 2, participants will receive intravenous and oral R-CHOP followed by intravenous rituximab in 21-day cycles.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-Cell Lymphoma
Keywords
Relapsed or Refractory Diffuse Large B-Cell Lymphoma, Non-Hodgkins Lymphoma, Cancer, Epcoritamab, ABBV-GMAB-3013, R-CHOP, Rituximab, EPCORE
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
900 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Epcoritamab and R-CHOP
Arm Type
Experimental
Arm Description
Participants will receive subcutaneous epcoritamab combined with intravenous and oral rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) followed by epcoritamab in 21-day cycles.
Arm Title
R-CHOP and Rituximab
Arm Type
Experimental
Arm Description
Participants will receive intravenous and oral R-CHOP followed by intravenous rituximab in 21-day cycles.
Intervention Type
Drug
Intervention Name(s)
Epcoritamab
Other Intervention Name(s)
ABBV-GMAB-3013
Intervention Description
Subcutaneous Injection (SC)
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Intravenous (IV) Injection
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
IV Infusion
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
IV Infusion
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
IV Infusion
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Oral; Tablet
Primary Outcome Measure Information:
Title
Number of Participants with Progression-Free Survival (PFS) with an International Prognostic Index (IPI) of 3-5
Description
PFS is defined as the duration from randomization to the date of disease progression as determined by Lugano 2014 criteria as assessed by Independent Review Committee (IRC), or death due to any cause whichever comes first.
Time Frame
Up to Approximately 46 Months
Secondary Outcome Measure Information:
Title
Number of Participants with PFS
Description
PFS is defined as the duration from randomization to the date of disease progression as determined by Lugano 2014 criteria as assessed by IRC, or death due to any cause, whichever occurs first.
Time Frame
Up to Approximately 46 Months
Title
Number of Participants with Event-free survival (EFS)
Description
EFS is defined as the duration from randomization to the date of disease progression determined by Lugano criteria as assessed by IRC, IRC-assessed PR or SD followed by non protocol-specified NALT, a positive biopsy on or after end-of-treatment (EOT), regardless of whether NAL initiated, or death from any cause.
Time Frame
Up to Approximately 46 Months
Title
Percentage of Participants with Complete Remission (CR)
Description
CR is defined as the absence of lymphoma determined by fluorodeoxyglucose positron emission tomography (FDG-PET),determined by Lugano 2014 criteria as assessed by IRC.
Time Frame
On or After to Approximately 28 Weeks
Title
Overall survival (OS)
Description
OS is defined as time from randomization until death due to any causes.
Time Frame
Up to Approximately 76 Months
Title
Percentage of Participants with Minimal Residual Disease (MRD) Negativity
Description
The MRD negativity rate is defined as the percentage of participants who achieve MRD negativity prior to the initiation of any non-protocol-specified new anti-lymphoma therapy.
Time Frame
Up to Approximately 46 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Planned to receive treatment with 6 cycles of standard rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) per investigator determination.
Must have newly diagnosed, histologically confirmed CD20+ diffuse large b-cell lymphoma [DLBCL] (de novo or histologically transformed from a diagnosis of follicular lymphoma) at most recent representative tumor biopsy based on the pathology report, with a World Health Organization (WHO) 2016 classification and including:
DLBCL, Not Otherwise Specified (NOS).
High grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangement with DLBCL morphology.
T-cell/histiocyte-rich large B-cell lymphoma.
Epstein Barr virus-positive DLBCL, NOS.
Follicular lymphoma Grade 3b.
Note: The local pathology report must be available at Screening to support CD20+ DLBCL histology.
Composite/intermediate histology with any of the following components is not allowed: high grade B-cell lymphoma, NOS; Hodgkin's lymphoma; primary mediastinal (thymic) large B-cell lymphoma; Burkitt; plasmablastic lymphoma or any CD20- lymphoma, such as anaplastic lymphoma kinase-positive large B-cell lymphoma, human herpesvirus type 8-positive DLBCL, or primary effusion lymphoma.
Availability of archival or freshly collected tumor tissue at Screening. Archival paraffin-embedded tissue must be obtained within 8 weeks prior to Cycle 1 Day 1.
Must have an IPI score of 2-5. The number of participants with IPI 2 will not exceed approximately 30% of the overall sample size.
Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 prior to initiating R-CHOP treatment. Note that participant with an initial ECOG performance status >= 3 may be screened if pre-phase treatment is planned. Participant may be eligible if ECOG performance status were to improve to 0-2 during pre-phase treatment.
Has at least one target lesion defined as:
>= 1 measurable nodal lesion (long axis > 1.5 cm ) or >= 1 measurable extra-nodal lesion (long axis > 1 cm) on computed tomography (CT) scan or magnetic resonance imaging (MRI). AND
Positron emission tomography (PET)-positive on PET-CT scan.
Laboratory values meeting the criteria laid out in the protocol.
Left ventricular ejection fraction must be >= 50% by multi-gated acquisition or transthoracic echocardiography at Screening.
Exclusion Criteria:
History of prior systemic anti-lymphoma therapy for diagnosed diffuse large b-cell lymphoma (DLBCL) including any definitive radiotherapy with curative intent] other than corticosteroids with or without vincristine during prephase treatment, or non-curative intent palliative radiotherapy with the stipulation that radiated lesions cannot be selected as target lesion for response assessment.
Clinically significant cardiovascular disease as per the protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Millennium Research & Clinical Development /ID# 228284
City
Kingwood
State/Province
Texas
ZIP/Postal Code
77339-6008
Country
United States
Individual Site Status
Recruiting
Facility Name
Liverpool Hospital /ID# 230072
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal Adelaide Hospital /ID# 225683
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Austin Health /ID# 225716
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Recruiting
Facility Name
Alfred Health /ID# 225999
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Name
Monash Medical Centre /ID# 225680
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Name
Hollywood Private Hospital /ID# 251837
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Name
Perth Blood Institute Ltd /ID# 225679
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal Perth Hospital /ID# 226583
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum St. Poelten /ID# 234016
City
Sankt Poelten
State/Province
Niederoesterreich
ZIP/Postal Code
3100
Country
Austria
Individual Site Status
Recruiting
Facility Name
Medizinische Universitaet Wien /ID# 252095
City
Vienna
State/Province
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Name
Klinik Ottakring /ID# 243941
City
Vienna
State/Province
Wien
ZIP/Postal Code
1160
Country
Austria
Individual Site Status
Recruiting
Facility Name
Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 228360
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Recruiting
Facility Name
CHU UCL Namur - site Godinne /ID# 225742
City
Godinne
State/Province
Namur
ZIP/Postal Code
5530
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Gent /ID# 250031
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
AZ-Delta /ID# 225736
City
Roeselare
State/Province
West-Vlaanderen
ZIP/Postal Code
8800
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Institut Jules Bordet /ID# 225954
City
Anderlecht
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Pôle Hospitalier Jolimont /ID# 225738
City
La Louvière
ZIP/Postal Code
7100
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 225952
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Vitaz /Id# 226153
City
Sint-Niklaas
ZIP/Postal Code
9100
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 226065
City
Jaú
State/Province
Sao Paulo
ZIP/Postal Code
17210-070
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 226809
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01509-900
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Real e Benemérita Associação Portuguesa de Beneficência /ID# 226023
City
Sao Paulo
ZIP/Postal Code
01323-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Alemao Oswaldo Cruz /ID# 252833
City
Sao Paulo
ZIP/Postal Code
01323-020
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 226048
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
UMHAT Sveti Georgi /ID# 245780
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Acibadem City Clinic Tokuda University Hospital EAD /ID# 244616
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
UMHAT Sveti Ivan Rilski /ID# 244615
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
SHAT Hematologic Diseases /ID# 250102
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Beijing Cancer Hospital /ID# 229819
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Name
Peking University Third Hospital /ID# 230975
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Name
Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 234152
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Nanchang University /ID# 230399
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Name
Shandong Cancer Hospital /ID# 233200
City
Jinan
State/Province
Shandong
ZIP/Postal Code
251601
Country
China
Individual Site Status
Recruiting
Facility Name
Clinical Hospital Dubrava /ID# 251809
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Klinicka bolnica Merkur /ID# 252481
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Klinicki bolnicki centar Zagreb /ID# 250709
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Klinicki bolnicki centar Rijeka /ID# 251811
City
Rijeka
State/Province
Primorsko-goranska Zupanija
ZIP/Postal Code
51000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Klinicki bolnicki centar Split /ID# 250729
City
Split
State/Province
Splitsko-dalmatinska Zupanija
ZIP/Postal Code
21000
Country
Croatia
Individual Site Status
Active, not recruiting
Facility Name
Opca bolnica Dr. Josip Bencevic /ID# 251812
City
Slavonski Brod
ZIP/Postal Code
35000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Fakultni Nemocnice Brno /ID# 225953
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Hradec Kralove /ID# 225955
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Ostrava /ID# 225957
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Rigshospitalet /ID# 226576
City
Copenhagen Ø
State/Province
Hovedstaden
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Zealand University Hospital, Roskilde /ID# 226597
City
Roskilde
State/Province
Sjælland
ZIP/Postal Code
4000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Odense University Hospital /ID# 226593
City
Odense C
State/Province
Syddanmark
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Sygehus Lillebalt, Vejle /ID# 226592
City
Vejle
State/Province
Syddanmark
ZIP/Postal Code
7100
Country
Denmark
Individual Site Status
Recruiting
Facility Name
CHU de Nice - Hôpital Archet 1 /ID# 226127
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06200
Country
France
Individual Site Status
Recruiting
Facility Name
HCL - Hopital Lyon Sud /ID# 227086
City
Pierre Benite CEDEX
State/Province
Auvergne-Rhone-Alpes
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Paoli-Calmettes /ID# 226557
City
Marseille
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13009
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Rennes - PONTCHAILLOU /ID# 228207
City
Rennes
State/Province
Bretagne
ZIP/Postal Code
35000
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Dijon /ID# 238345
City
Dijon
State/Province
Cote-d Or
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Limoges - Dupuytren 1 /ID# 234235
City
Limoges CEDEX 1
State/Province
Franche-Comte
ZIP/Postal Code
87042
Country
France
Individual Site Status
Recruiting
Facility Name
CHRU Lille - Hopital Claude Huriez /ID# 226101
City
Lille
State/Province
Hauts-de-France
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Montpellier - Hôpital Saint Eloi /ID# 228191
City
Montpellier Cedex 5
State/Province
Herault
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Nantes, Hotel Dieu -HME /ID# 226125
City
Nantes
State/Province
Pays-de-la-Loire
ZIP/Postal Code
44000
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier de la Cote Basque /ID# 249143
City
Bayonne
State/Province
Pyrenees-Atlantiques
ZIP/Postal Code
64100
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Amiens-Picardie Site Sud /ID# 238347
City
Amiens CEDEX 1
State/Province
Somme
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Name
Chu Angers /Id# 245931
City
Angers
ZIP/Postal Code
49933
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de CAEN - Hopital de la Cote de Nacre /ID# 226582
City
Caen
ZIP/Postal Code
14033
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Henri Mondor /ID# 226560
City
Creteil
ZIP/Postal Code
94000
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Grenoble - Hopital Michallon /ID# 226128
City
La Tronche
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Name
AP-HP - Hopital Saint-Louis /ID# 226126
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Name
General Hospital of Athens Laiko /ID# 225399
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Recruiting
Facility Name
Alexandra General Hospital /ID# 225402
City
Athens
State/Province
Attiki
ZIP/Postal Code
11528
Country
Greece
Individual Site Status
Recruiting
Facility Name
University General Hospital Attikon /ID# 225401
City
Athens
State/Province
Attiki
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Name
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 225416
City
Athens
ZIP/Postal Code
10676
Country
Greece
Individual Site Status
Recruiting
Facility Name
University General Hospital of Ioannina /ID# 225400
City
Ioannina
ZIP/Postal Code
45500
Country
Greece
Individual Site Status
Recruiting
Facility Name
General University Hospital of Thessaloniki AXEPA /ID# 225398
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
Individual Site Status
Recruiting
Facility Name
Theageneio Anticancer Hospital /ID# 225516
City
Thessaloniki
ZIP/Postal Code
54639
Country
Greece
Individual Site Status
Recruiting
Facility Name
Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 245938
City
Kaposvár
State/Province
Somogy
ZIP/Postal Code
7400
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Markusovszky Egyetemi Oktatokorhaz /ID# 226846
City
Szombathely
State/Province
Vas
ZIP/Postal Code
9700
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Semmelweis Egyetem /ID# 227239
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Orszagos Onkologiai Intezet /ID# 227294
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Tolna Megyei Balassa Janos Korhaz /ID# 250063
City
Szekszard
ZIP/Postal Code
7100
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Assuta Tel Aviv Medical Center /ID# 226066
City
Tel Aviv
State/Province
HaMerkaz
ZIP/Postal Code
6971028
Country
Israel
Individual Site Status
Recruiting
Facility Name
The Chaim Sheba Medical Center /ID# 225600
City
Ramat Gan
State/Province
Tel-Aviv
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Tel Aviv Sourasky Medical Center /ID# 225891
City
Tel Aviv-Yafo
State/Province
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Name
Hadassah /ID# 225614
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Individual Site Status
Recruiting
Facility Name
Meir Medical Center /ID# 225612
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rabin Medical Center /ID# 225862
City
Petakh Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Name
IEO -Istituto Europeo di Oncologia /ID# 225545
City
Milan
State/Province
Milano
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 225751
City
Candiolo
State/Province
Torino
ZIP/Postal Code
10060
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo /ID# 225542
City
Alessandria
ZIP/Postal Code
15121
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASST Spedali civili di Brescia /ID# 225549
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Federico II /ID# 225543
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 225773
City
Novara
ZIP/Postal Code
28100
Country
Italy
Individual Site Status
Recruiting
Facility Name
A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 225541
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Santa Maria delle Croci /ID# 225571
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Individual Site Status
Recruiting
Facility Name
NHO Nagoya Medical Center /ID# 230677
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Individual Site Status
Recruiting
Facility Name
Aichi Cancer Center Hospital /ID# 226090
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Cancer Center Hospital East /ID# 250151
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Recruiting
Facility Name
Matsuyama Red Cross Hospital /ID# 251068
City
Matsuyama-shi
State/Province
Ehime
ZIP/Postal Code
790-8524
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Kyushu Cancer Center /ID# 251622
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kyushu University Hospital /ID# 226091
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fukushima Medical University Hospital /ID# 250869
City
Fukushima-shi
State/Province
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hokkaido University Hospital /ID# 250149
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kobe City Medical Center General Hospital /ID# 250597
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Individual Site Status
Recruiting
Facility Name
University of Tsukuba Hospital /ID# 251282
City
Tsukuba-shi
State/Province
Ibaraki
ZIP/Postal Code
305-8576
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kanazawa University Hospital /ID# 251770
City
Kanazawa-shi
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kagoshima University Hospital /ID# 250163
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
890-8520
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokai University Hospital /ID# 251281
City
Isehara-shi
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tohoku University Hospital /ID# 250150
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
9808574
Country
Japan
Individual Site Status
Recruiting
Facility Name
Okayama University Hospital /ID# 250161
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kindai University Hospital /ID# 250160
City
Osakasayama-shi
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka University Hospital /ID# 251283
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Cancer Center Hospital /ID# 226089
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Recruiting
Facility Name
The Cancer Institute Hospital Of JFCR /ID# 230269
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yamagata University Hospital /ID# 230003
City
Yamagata-shi
State/Province
Yamagata
ZIP/Postal Code
990-9585
Country
Japan
Individual Site Status
Recruiting
Facility Name
Seoul National University Bundang Hospital /ID# 225763
City
Seongnam
State/Province
Gyeonggido
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Inje University Busan Paik Hospital /ID# 232262
City
Busan
ZIP/Postal Code
47392
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Dong-A University Hospital /ID# 228451
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Keimyung University Dongsan Medical Center /ID# 232264
City
Daegu
ZIP/Postal Code
41931
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Jeonbuk National University Hospital /ID# 232263
City
Jeonju
ZIP/Postal Code
54907
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital /ID# 225760
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center /ID# 225758
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center /ID# 225759
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 225761
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Ulsan University Hospital /ID# 226971
City
Ulsan
ZIP/Postal Code
44033
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Flevoziekenhuis /ID# 229606
City
Almere
State/Province
Flevoland
ZIP/Postal Code
1315 RA
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Gelre Ziekenhuizen /ID# 229762
City
Apeldoorn
State/Province
Gelderland
ZIP/Postal Code
7334 DZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Tergooi /ID# 229772
City
Hilversum
State/Province
Noord-Holland
ZIP/Postal Code
1213 XZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Zaans Medisch Centrum /ID# 230614
City
Zaandam
State/Province
Noord-Holland
ZIP/Postal Code
1502 DV
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Albert Schweitzer Ziekenhuis /ID# 229560
City
Dordrecht
State/Province
Zuid-Holland
ZIP/Postal Code
3318 AT
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Noordwest Ziekenhuisgroep /ID# 230613
City
Alkmaar
ZIP/Postal Code
1815 JD
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Meander Medisch Centrum /ID# 229608
City
Amersfoort
ZIP/Postal Code
3813 TZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Vrije Universiteit Medisch Centrum /ID# 225608
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Onze Lieve Vrouwe Gasthuis /ID# 229761
City
Amsterdam
ZIP/Postal Code
1091 AC
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Amphia Ziekenhuis /ID# 229550
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Haaglanden Medisch Centrum /ID# 229686
City
Den Haag
ZIP/Postal Code
2512 VA
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Deventer Ziekenhuis /ID# 229937
City
Deventer
ZIP/Postal Code
7416 SE
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Catharina Ziekenhuis /ID# 230465
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Maxima Medisch Centrum /ID# 225603
City
Eindhoven
ZIP/Postal Code
5631 BM
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Medisch Spectrum Twente /ID# 225610
City
Enschede
ZIP/Postal Code
7512 KZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Universitair Medisch Centrum Groningen /ID# 225602
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Medisch Centrum Leeuwarden /ID# 225605
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
St. Antonius Ziekenhuis /ID# 229901
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Canisius-Wilhelmina Ziekenhuis /ID# 231291
City
Nijmegen
ZIP/Postal Code
6532 SZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Jeroen Bosch Ziekenhuis /ID# 229765
City
S Hertogenbosch
ZIP/Postal Code
5223 GZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Elisabeth Tweesteden Ziekenhuis /ID# 229773
City
Tilburg
ZIP/Postal Code
5022 GC
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Diakonessenhuis /ID# 251793
City
Utrecht
ZIP/Postal Code
3582 KE
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
North Shore Hospital /ID# 250992
City
Takapuna
State/Province
Auckland
ZIP/Postal Code
0622
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Christchurch Hospital /ID# 250993
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
8011
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka /ID# 228723
City
Slupsk
State/Province
Pomorskie
ZIP/Postal Code
76-200
Country
Poland
Individual Site Status
Recruiting
Facility Name
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 225986
City
Kielce
State/Province
Swietokrzyskie
ZIP/Postal Code
25-734
Country
Poland
Individual Site Status
Recruiting
Facility Name
SP ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii /ID# 225985
City
Olsztyn
State/Province
Warminsko-mazurskie
ZIP/Postal Code
10-228
Country
Poland
Individual Site Status
Recruiting
Facility Name
ARS-MEDICAL Sp. z o.o. /ID# 225848
City
Pila
State/Province
Wielkopolskie
ZIP/Postal Code
64-920
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Pratia Poznan /ID# 227236
City
Skorzewo
State/Province
Wielkopolskie
ZIP/Postal Code
60-185
Country
Poland
Individual Site Status
Recruiting
Facility Name
CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 225809
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Parc de Salut del Mar /ID# 225810
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Vall d'Hebron /ID# 225811
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinic de Barcelona /ID# 226651
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Santa Creu i Sant Pau /ID# 225813
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Reina Sofia /ID# 225806
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 228228
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Infanta Leonor /ID# 225816
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Individual Site Status
Recruiting
Facility Name
MD Anderson Madrid /ID# 225817
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Ramon y Cajal /ID# 241750
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Fundacion Jimenez Diaz /ID# 225804
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre /ID# 225815
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario de Valencia /ID# 225818
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Sodra Alvsborgs sjukhus /ID# 228885
City
Boras
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
501 82
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Linkoping University Hospital /ID# 233521
City
Linkoping
ZIP/Postal Code
581 85
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Kantonsspital Aarau AG /ID# 229112
City
Aarau
State/Province
Aargau
ZIP/Postal Code
5001
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Spital Thun /ID# 229499
City
Thun
State/Province
Bern
ZIP/Postal Code
3600
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Kaohsiung Chang Gung Memorial Hospital /ID# 226670
City
Kaohsiung City
State/Province
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
China Medical University Hospital /ID# 226188
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taichung Veterans General Hospital /ID# 226674
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Cheng Kung University Hospital /ID# 226671
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.abbvieclinicaltrials.com/study/?id=M23-362
Description
Related info
Learn more about this trial
A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)
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