Phase
Condition
Lymphoma
Hematologic Cancer
Lymphoma, B-cell
Treatment
Rituximab Biosimilar
Rituximab
Doxorubicin
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Has histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), byprior biopsy, based on local testing according to the WHO classification ofneoplasms of the hematopoietic and lymphoid tissues
Has positron emission tomography (PET) positive disease at screening, defined as 4to 5 on the Lugano 5-point scale
Has received no prior treatment for their DLBCL
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2assessed within 7 days before randomization
Has an ejection fraction ≥45% as determined by either echocardiogram (ECHO) ormultigated acquisition (MUGA)
Human immunodeficiency virus (HIV) infected participants must have well controlledHIV on antiretroviral therapy (ART)
Who are hepatitis B surface antigen (HBsAg) positive are eligible if they havereceived hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viralload prior to randomization
Participants with history of hepatitis C virus (HCV) infection are eligible if HCVviral load is undetectable at screening
Exclusion
Exclusion Criteria:
Has a history of transformation of indolent disease to DLBCL
Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zonelymphoma
Has Ann Arbor Stage I DLBCL
Has clinically significant (i.e., active) cardiovascular disease: cerebral vascularaccident/stroke (<6 months prior to enrollment), myocardial infarction (<6 monthsprior to enrollment), unstable angina, congestive heart failure (New York HeartAssociation Classification Class ≥II), or serious cardiac arrhythmia requiringmedication
Has clinically significant pericardial or pleural effusion
Has ongoing Grade >1 peripheral neuropathy
Has a demyelinating form of Charcot-Marie-Tooth disease
HIV-infected participants with a history of Kaposi's sarcoma and/or MulticentricCastleman's Disease
Has ongoing corticosteroid therapy
Has received a live or live-attenuated vaccine within 30 days before the first doseof study intervention. Administration of killed vaccines is allowed
Known additional malignancy that is progressing or has required active treatmentwithin the past 2 years
Known active central nervous system (CNS) lymphoma
Has active autoimmune disease that has required systemic treatment in the past 2years
Has active infection requiring systemic therapy
Has concurrent active HBV (defined as HBsAg positive and detectable HBV DNA) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA))infection
Has history of allogeneic tissue/solid organ transplant
Study Design
Connect with a study center
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0306)
Mar del Plata, Buenos Aires B7600FZO
ArgentinaActive - Recruiting
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0306)
Mar del Plata., Buenos Aires B7600FZO
ArgentinaSite Not Available
Fundacion Estudios Clinicos ( Site 0311)
Rosario., Santa Fe S2000CEJ
ArgentinaActive - Recruiting
Hospital Italiano de Buenos Aires ( Site 0304)
Caba, C1199ABB
ArgentinaActive - Recruiting
ASBL CHU Helora - Hôpital de Mons - Site Kennedy ( Site 1103)
Mons, Hainaut 7000
BelgiumActive - Recruiting
Hospital Erasto Gaertner ( Site 0401)
Curitiba, Parana 82520-060
BrazilActive - Recruiting
Liga Norte Riograndense Contra o Cancer ( Site 0407)
Natal, Rio Grande Do Norte 59062-000
BrazilActive - Recruiting
CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0403)
Florianópolis, Santa Catarina 88020-210
BrazilActive - Recruiting
Hope ( Site 0413)
Ribeirao Preto, Sao Paulo 14026-610
BrazilActive - Recruiting
Clinica Advanze ( Site 0411)
Sao Carlos, Sao Paulo 13561-130
BrazilActive - Recruiting
F. F. R. M. São Jose do Rio Preto ( Site 0404)
Sjrp, Sao Paulo 15090-000
BrazilActive - Recruiting
Biocenter ( Site 0510)
Concepcion., Biobio 4070196
ChileActive - Recruiting
Centro de Estudios Clínicos SAGA ( Site 0508)
Santiago, Region M. De Santiago 7500653
ChileActive - Recruiting
Beijing Cancer Hospital ( Site 3101)
Beijing, Beijing 100142
ChinaActive - Recruiting
Chongqing Cancer Hospital ( Site 3113)
Chongqing, Chongqing 400030
ChinaActive - Recruiting
Fujian Provincial Cancer Hospital. ( Site 3119)
Fuzhou, Fujian 350014
ChinaActive - Recruiting
Zhujiang Hospital of Southern Medical University ( Site 3122)
Guangzhou, Guangdong 510280
ChinaActive - Recruiting
Affiliated Cancer Hospital of Guangxi Medical University ( Site 3123)
Nanning, Guangxi 530021
ChinaActive - Recruiting
The Affiliated Hospital of Guizhou Medical University ( Site 3112)
Guiyang, Guizhou 550004
ChinaActive - Recruiting
Hubei Cancer Hospital ( Site 3125)
Wuhan, Hubei 430079
ChinaActive - Recruiting
Affiliated Hospital of Nantong University ( Site 3117)
Nantong, Jiangsu 226001
ChinaActive - Recruiting
Jiangxi Cancer Hospital ( Site 3118)
Nanchang, Jiangxi 330029
ChinaActive - Recruiting
Shandong Cancer Hospital ( Site 3108)
Jinan, Shandong 250117
ChinaActive - Recruiting
Sichuan Cancer Hospital. ( Site 3111)
Chengdu, Sichuan 610041
ChinaActive - Recruiting
West China Hospital, Sichuan University ( Site 3110)
Chengdu, Sichuan 610041
ChinaActive - Recruiting
Institute of Hematology and Blood Diseases Hosp CAMS&PUMC ( Site 3105)
Tianjin, Tianjin 301617
ChinaActive - Recruiting
Yunnan Province Cancer Hospital ( Site 3109)
Kunming, Yunnan 650118
ChinaActive - Recruiting
The First Affiliated Hospital, Zhejiang Medical University ( Site 3116)
Hangzhou, Zhejiang 310009
ChinaActive - Recruiting
Hospital Pablo Tobon Uribe ( Site 0604)
Medellin, Antioquia 050034
ColombiaActive - Recruiting
IMAT S.A.S ( Site 0603)
Montería, Cordoba 230002
ColombiaActive - Recruiting
Hospital Universitario San Ignacio ( Site 0607)
Bogota., Distrito Capital De Bogota 110231
ColombiaActive - Recruiting
Oncologos del Occidente ( Site 0601)
Pereira., Risaralda 660001
ColombiaActive - Recruiting
Fundación Valle del Lili ( Site 0602)
Cali, Valle Del Cauca 760032
ColombiaActive - Recruiting
Aalborg University Hospital ( Site 1302)
Aalborg, Nordjylland 9000
DenmarkActive - Recruiting
CHU Dijon Bourgogne ( Site 1516)
Dijon, Cote-d Or 21000
FranceActive - Recruiting
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 1512)
Limoges, Limousin 87042
FranceActive - Recruiting
Centre Hospitalier Régional Metz Thionville - Hôpital de Mercy ( Site 1515)
Metz, Moselle 57085
FranceActive - Recruiting
Centre Hospitalier de Dunkerque ( Site 1513)
Dunkerque, Nord 59385
FranceActive - Recruiting
Centre Hospitalier de la Cote Basque ( Site 1509)
Bayonne, Pyrenees-Atlantiques 64100
FranceActive - Recruiting
HIA Sainte Anne ( Site 1506)
Toulon, Var 83800
FranceActive - Recruiting
Centre Hospitalier d'Avignon ( Site 1505)
Avignon, Vaucluse 84000
FranceActive - Recruiting
CHD Vendee ( Site 1502)
La Roche-sur-Yon, Vendee 85000
FranceActive - Recruiting
Cen Integral Onco Gastro y Hemato Onco Guatemala S.A. ( Site 0703)
Guatemala, 01010
GuatemalaActive - Recruiting
MEDI-K ( Site 0701)
Guatemala, 01009
GuatemalaActive - Recruiting
CELAN,S.A ( Site 0702)
Guatemala., 01010
GuatemalaActive - Recruiting
Princess Margaret Hospital ( Site 3202)
Hong Kong,
Hong KongActive - Recruiting
Queen Mary Hospital ( Site 3201)
Hong Kong,
Hong KongActive - Recruiting
Carmel Hospital ( Site 1903)
Haifa, 3436212
IsraelActive - Recruiting
Hadassah Medical Center ( Site 1901)
Jerusalem, 9112001
IsraelActive - Recruiting
Sourasky Medical Center ( Site 1904)
Tel Aviv, 6423906
IsraelActive - Recruiting
Poria Medical Center ( Site 1902)
Tiberias, 15208
IsraelActive - Recruiting
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia ( Site 2010)
Candiolo, Torino 10060
ItalyActive - Recruiting
AOU delle Marche Ospedali Riuniti di Ancona ( Site 2011)
Ancona, 60126
ItalyActive - Recruiting
IEO Istituto Europeo di Oncologia ( Site 2009)
Milano, 20141
ItalyActive - Recruiting
Ospedale Santa Maria delle Croci ( Site 2006)
Ravenna, 48121
ItalyActive - Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore (
Roma, 00168
ItalyActive - Recruiting
Nagoya University Hospital ( Site 3309)
Nagoya, Aichi 466-8560
JapanActive - Recruiting
National Hospital Organization Shikoku Cancer Center ( Site 3321)
Matsuyama, Ehime 791-0280
JapanActive - Recruiting
Kobe City Medical Center General Hospital ( Site 3318)
Kobe, Hyogo 650-0047
JapanActive - Recruiting
Kanazawa University Hospital ( Site 3308)
Kanazawa, Ishikawa 920-8641
JapanActive - Recruiting
Tokai University Hospital ( Site 3302)
Isehara, Kanagawa 259-1193
JapanActive - Recruiting
Tohoku University Hospital ( Site 3301)
Sendai, Miyagi 980-8574
JapanActive - Recruiting
Kindai University Hospital ( Site 3310)
Osakasayama, Osaka 589-8511
JapanActive - Recruiting
Saitama Medical University Hospital ( Site 3305)
Iruma-gun, Saitama 350-0495
JapanActive - Recruiting
Juntendo University Hospital ( Site 3307)
Bunkyo, Tokyo 113-8431
JapanActive - Recruiting
University of Yamanashi Hospital ( Site 3320)
Chuo, Yamanashi 409-3898
JapanActive - Recruiting
Chiba Cancer Center ( Site 3314)
Chiba, 260-8717
JapanActive - Recruiting
Kyushu University Hospital ( Site 3313)
Fukuoka, 812-8582
JapanActive - Recruiting
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital ( Site 3322)
Hiroshima, 730-8619
JapanActive - Recruiting
University Hospital,Kyoto Prefectural University of Medicine ( Site 3315)
Kyoto, 602-8566
JapanActive - Recruiting
University of Miyazaki Hospital ( Site 3319)
Miyazaki, 889-1692
JapanActive - Recruiting
Okayama University Hospital ( Site 3311)
Okayama, 700-8558
JapanActive - Recruiting
Osaka Metropolitan University Hospital ( Site 3317)
Osaka, 545-8586
JapanActive - Recruiting
Yamagata University Hospital ( Site 3312)
Yamagata, 990-9585
JapanActive - Recruiting
National Cancer Center- Center for Hemotologic malignancy ( Site 3806)
Goyang-si, Kyonggi-do 10408
Korea, Republic ofActive - Recruiting
Pusan National University Hospital ( Site 3804)
Busan, Pusan-Kwangyokshi 49241
Korea, Republic ofActive - Recruiting
Chungnam National University Hospital ( Site 3801)
Daejeon, Taejon-Kwangyokshi 35015
Korea, Republic ofActive - Recruiting
Samsung Medical Center ( Site 3807)
Seoul, 06351
Korea, Republic ofActive - Recruiting
Severance Hospital, Yonsei University Health System ( Site 3802)
Seoul, 03722
Korea, Republic ofActive - Recruiting
St.Mary's H., Youido ( Site 3805)
Seoul, 07345
Korea, Republic ofActive - Recruiting
Queen Elizabeth Hospital ( Site 3405)
Kota Kinabalu, Sabah 88586
MalaysiaActive - Recruiting
Hospital Miri ( Site 3403)
Miri, Sarawak 98000
MalaysiaActive - Recruiting
Meander Medisch Centrum ( Site 2101)
Amersfoort, Utrecht 3813 TZ
NetherlandsActive - Recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2201)
Warszawa, Mazowieckie 02-781
PolandActive - Recruiting
Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku ( Site 2210)
Słupsk, Pomorskie 76-200
PolandActive - Recruiting
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2208)
Gliwice, Slaskie 44-102
PolandActive - Recruiting
Pratia Onkologia Katowice ( Site 2204)
Katowice, Slaskie 40-519
PolandActive - Recruiting
Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko-Mazurskim Centrum Onko
Olsztyn, Warminsko-mazurskie 10-228
PolandActive - Recruiting
BRCR Global - Mayaguez ( Site 1003)
Mayaguez, 00682
Puerto RicoActive - Recruiting
Auxilio Mutuo Cancer Center ( Site 1001)
San Juan, 00918
Puerto RicoActive - Recruiting
Institutul Oncologic Cluj ( Site 2404)
Cluj-Napoca, Cluj 4003437
RomaniaActive - Recruiting
Spital Judetean Sibiu ( Site 2405)
Sibiu, 550245
RomaniaActive - Recruiting
National Cancer Centre Singapore ( Site 3701)
Singapore, Central Singapore 168583
SingaporeActive - Recruiting
Hospital Universitario Virgen Macarena ( Site 2608)
Sevilla, Andalucia 41009
SpainActive - Recruiting
H. Insular de Gran Canaria ( Site 2606)
Las Palmas de Gran Canaria, Las Palmas 35016
SpainActive - Recruiting
Hospital General Universitario Dr. Balmis ( Site 2604)
Alicante, Valenciana, Comunitat 03010
SpainActive - Recruiting
Hospital del Mar ( Site 2610)
Barcelona, 08003
SpainActive - Recruiting
Hospital Universitario La Paz ( Site 2611)
Madrid, 28046
SpainActive - Recruiting
Hospital Virgen de la Victoria ( Site 2609)
Malaga, 29010
SpainActive - Recruiting
Ospedale Regionale Bellinzona e Valli ( Site 2701)
Bellinzona, Ticino 6501
SwitzerlandActive - Recruiting
National Cheng Kung University Hospital ( Site 3902)
Tainan, 704
TaiwanActive - Recruiting
Mackay Memorial Hospital ( Site 3908)
Taipei, 10049
TaiwanActive - Recruiting
National Taiwan University Hospital ( Site 3901)
Taipei, 100
TaiwanActive - Recruiting
Tri-Service General Hospital ( Site 3906)
Taipei, 11490
TaiwanActive - Recruiting
Chang Gung Memorial Hospital - Linkou Branch ( Site 3903)
Taoyuan, 333
TaiwanActive - Recruiting
MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( S
Cherkasy, Cherkaska Oblast 18009
UkraineActive - Recruiting
Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council" ( Si
Ivano-Frankivsk, Ivano-Frankivska Oblast 76008
UkraineActive - Recruiting
Khmelnytskyi Regional Hospital ( Site 2907)
Khmelnytskiy, Khmelnytska Oblast 29000
UkraineActive - Recruiting
Institute of Blood Pathology and Transfusion Medicine AMS Ukraine ( Site 2903)
Lviv, Lvivska Oblast 79057
UkraineActive - Recruiting
Public Non-Profit Enterprise Kyiv City Clinical Hospital #9 under the Executive Body of Kyiv City Co
Kyiv, 04112
UkraineActive - Recruiting
SNPE National Cancer Institute ( Site 2902)
Kyiv, 03022
UkraineActive - Recruiting
Universal Clinic Oberig ( Site 2908)
Kyiv, 03057
UkraineActive - Recruiting
Cancer Blood and Specialty Clinic ( Site 0109)
Los Alamitos, California 90720
United StatesActive - Recruiting
Cancer Care Specialists of Illinois ( Site 0152)
O'Fallon, Illinois 62269
United StatesActive - Recruiting
Fort Wayne Medical Oncology and Hematology ( Site 0149)
Fort Wayne, Indiana 46804
United StatesActive - Recruiting
Cotton O'Neil Cancer Center ( Site 0108)
Topeka, Kansas 66606
United StatesActive - Recruiting
Truman Medical Center ( Site 0122)
Kansas City, Missouri 64108
United StatesActive - Recruiting
Comprehensive Cancer Centers of Nevada ( Site 0113)
Las Vegas, Nevada 89169
United StatesActive - Recruiting
OptumCare Cancer Care ( Site 0121)
Las Vegas, Nevada 89102
United StatesActive - Recruiting
New York Oncology Hematology, P.C. ( Site 0129)
Albany, New York 12206
United StatesActive - Recruiting
University of Virginia Cancer Center ( Site 0138)
Charlottesville, Virginia 22903
United StatesActive - Recruiting
Virginia Cancer Institute ( Site 0148)
Richmond, Virginia 23229
United StatesActive - Recruiting
Blue Ridge Cancer Care ( Site 0132)
Roanoke, Virginia 24014
United StatesActive - Recruiting
SSM Health Dean Medical Group ( Site 0140)
Madison, Wisconsin 53715
United StatesActive - Recruiting
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