Phase
Condition
Lymphoma
Lymphoma, B-cell
Hematologic Cancer
Treatment
Gemcitabine
Granulocyte Colony-Stimulating Factor (G-CSF)
Bendamustine
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Has a histologically confirmed diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL).
Has radiographically measurable DLBCL per the Lugano Response Criteria, as assessedlocally by the investigator.
Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 within 7 days prior to study treatment initiation.
Has adequate organ function.
Is able to provide new or archival tumor tissue sample not previously irradiated.
Zilovertamab vedotin plus R-GemOx, or R-GemOx study arms:
Has relapsed or refractory DLBCL and is ineligible for or have failed autologousstem-cell transplant (ASCT) and have failed at least 1 line of prior therapy.
Has post-chimeric antigen receptor T (post-CAR-T) cell therapy failure or isineligible for CAR-T cell therapy.
Not applicable with protocol amendment 4: Zilovertamab vedotin plus Bendamustine Rituximab (BR), and Bendamustine Rituximab study arms:
Has relapsed or refractory DLBCL and is ineligible for or have failed ASCT and havefailed at least 2 lines of prior therapy.
Has post-CAR-T therapy failure or is ineligible for CAR-T cell therapy.
Exclusion
Exclusion Criteria:
Not applicable with protocol amendment 4: Has history of transformation of indolentdisease to DLBCL
Has received solid organ transplant at any time.
Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL).
Has clinically significant (ie, active) cardiovascular disease or serious cardiacarrhythmia requiring medication.
Has ongoing graft-versus-host disease (GVHD) of any grade, or is receiving treatmentfor their GVHD.
Has clinically significant pericardial or pleural effusion.
Has ongoing Grade >1 peripheral neuropathy.
Has a history of a second malignancy, unless potentially curative treatment has beencompleted with no evidence of malignancy for 2 years.
Has a demyelinating form of Charcot-Marie-Tooth disease.
Has contraindication to any of the study intervention components including but notlimited to prior anaphylactic reaction.
Has received prior systemic anticancer therapy, including investigational agentswithin 4 weeks prior to the first dose of study intervention.
Has received prior radiotherapy within 4 weeks of start of study intervention.Participants must have recovered from all radiation-related toxicities, not requirecorticosteroids, and not have had radiation pneumonitis.
Has ongoing corticosteroid therapy.
Has received a live or live-attenuated vaccine within 30 days before the first doseof study intervention.
Is currently participating in or has participated in a study of an investigationalagent or has used an investigational device within 4 weeks before the first dose ofstudy intervention.
Has known active central nervous system (CNS) lymphoma involvement or active CNSinvolvement by lymphoma. Participants with prior CNS involvement are eligible iftheir CNS disease is in radiographic, cytological (for cerebrospinal fluid disease),and clinical remission.
Has an active infection requiring systemic therapy.
Has a known history of human immunodeficiency virus (HIV) infection.
Has a known active Hepatitis C virus infection.
Has a known psychiatric or substance abuse disorder that would interfere with theparticipant's ability to cooperate with the requirements of the study.
Study Design
Connect with a study center
Hospital Aleman ( Site 2200)
Buenos Aites, Caba C1118AAT
ArgentinaActive - Recruiting
Townsville University Hospital ( Site 1800)
Douglas, Queensland 4814
AustraliaActive - Recruiting
Grampians Health ( Site 1802)
Ballarat, Victoria 3350
AustraliaActive - Recruiting
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0200)
Toronto, Ontario M5G 2M9
CanadaCompleted
Biocenter ( Site 2401)
Concepcion, Biobio 4070196
ChileSite Not Available
Biocenter ( Site 2401)
Concepcion., Biobio 4070196
ChileActive - Recruiting
IC La Serena Research ( Site 2405)
La Serena, Coquimbo 1720430
ChileActive - Recruiting
Oncocentro Valdivia ( Site 2407)
Valdivia, Los Rios 5112129
ChileSite Not Available
Oncocentro Valdivia ( Site 2407)
Valdivia., Los Rios 5112129
ChileActive - Recruiting
Bradfordhill ( Site 2403)
Santiago, Region M. De Santiago 8420383
ChileActive - Recruiting
Clínica Inmunocel ( Site 2404)
Santiago, Region M. De Santiago 7580206
ChileActive - Recruiting
Clínica RedSalud Vitacura ( Site 2409)
Santiago, Region M. De Santiago 7650018
ChileActive - Recruiting
Beijing Cancer hospital ( Site 3000)
Beijing, Beijing 100142
ChinaActive - Recruiting
Chongqing University Cancer Hospital-Medical Oncology ( Site 3025)
Chongqing, Chongqing 400030
ChinaActive - Recruiting
Chongqing University Three Gorges Hospital ( Site 3026)
Chongqing, Chongqing 404199
ChinaActive - Recruiting
Sun Yat-sen University Cancer Center-Internal Medicine ( Site 3001)
Guangzhou, Guangdong 510060
ChinaActive - Recruiting
Zhujiang Hospital ( Site 3002)
Guangzhou, Guangdong 510280
ChinaActive - Recruiting
The First Affiliated Hospital of Henan University of Science &Technology ( Site 3029)
Luoyang, Henan 471003
ChinaActive - Recruiting
Henan Cancer Hospital-hematology department ( Site 3013)
Zhengzhou, Henan 450008
ChinaActive - Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 3017)
Wuhan, Hubei 430048
ChinaActive - Recruiting
Jiangxi Provincial Cancer Hospital ( Site 3005)
Nanchang, Jiangxi 330029
ChinaActive - Recruiting
The First Affiliated Hospital of Nanchang University ( Site 3004)
Nanchang, Jiangxi 330006
ChinaActive - Recruiting
The First Hospital of Jilin University-Hematology ( Site 3012)
Changchun, Jilin 130021
ChinaActive - Recruiting
Fudan University Shanghai Cancer Center ( Site 3009)
Shanghai, Shanghai 200032
ChinaActive - Recruiting
West China Hospital of Sichuan University-Head and Neck Oncology ( Site 3016)
Cheng Du, Sichuan 610041
ChinaActive - Recruiting
Sichuan Cancer hospital-Oncology ( Site 3021)
Chengdu, Sichuan 610042
ChinaActive - Recruiting
Zhejiang Cancer Hospital ( Site 3014)
Hangzhou, Zhejiang 310000
ChinaActive - Recruiting
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Sit
Bogota, Distrito Capital De Bogota 110131
ColombiaActive - Recruiting
Fundacion Valle del Lili ( Site 0802)
Cali, Valle Del Cauca 760032
ColombiaActive - Recruiting
Hospital Metropolitano - Sede Lindora ( Site 2500)
Santa Ana, San Jose 10903
Costa RicaActive - Recruiting
CIMCA ( Site 2501)
San Jose, 10103
Costa RicaActive - Recruiting
centre hospitalier lyon sud-Service Hématologie ( Site 0702)
Pierre-Bénite, Rhone 69310
FranceSite Not Available
Pitie Salpetriere University Hospital-Clinical haematology ( Site 0700)
Paris, 75013
FranceActive - Recruiting
University Hospital of Alexandroupolis ( Site 0903)
Alexandroupolis, Anatoliki Makedonia Kai Thraki 681 00
GreeceActive - Recruiting
Evangelismos General Hospital of Athens ( Site 0900)
Athens, Attiki 106 76
GreeceActive - Recruiting
Regional General Hospital of Athens "Laiko" ( Site 0901)
Athens, Attiki 115 26
GreeceActive - Recruiting
CELAN,S.A ( Site 2603)
Guatemala, 1010
GuatemalaActive - Recruiting
MEDI-K ( Site 2602)
Guatemala, 01009
GuatemalaActive - Recruiting
Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 2601)
Guatemala, 01010
GuatemalaActive - Recruiting
Princess Margaret Hospital ( Site 3101)
Hong Kong,
Hong KongActive - Recruiting
Queen Mary Hospital ( Site 3100)
Hong Kong, 000000
Hong KongActive - Recruiting
Emek Medical Center-Hematology Unit ( Site 1102)
Afula, 1834111
IsraelCompleted
Carmel Hospital ( Site 1103)
Haifa, 3436212
IsraelCompleted
Hadassah Medical Center ( Site 1100)
Jerusalem, 9112001
IsraelCompleted
Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1203)
Rozzano, Milano 20089
ItalyActive - Recruiting
IRCCS - AOU di Bologna-Istituto di Ematologia "L. e A. Seragnoli" ( Site 1200)
Bologna, 40138
ItalyCompleted
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1202)
Napoli, 80131
ItalyActive - Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -ISTITUTO DI EMATOLOGIA ( Site 1204)
Roma, 00168
ItalyCompleted
Samsung Medical Center ( Site 0300)
Seoul, 06351
Korea, Republic ofActive - Recruiting
Seoul National University Hospital-Oncology ( Site 0302)
Seoul, 03080
Korea, Republic ofActive - Recruiting
Aotearoa Clinical Trials ( Site 0501)
Auckland, 2025
New ZealandActive - Recruiting
Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku ( Site
Wroclaw, Dolnoslaskie 50-367
PolandCompleted
Centrum Onkologii Ziemi Lubelskiej-Oddzial Hematologiczny ( Site 1304)
Lublin, Lubelskie 20-090
PolandActive - Recruiting
Centrum Onkologii Ziemi Lubelskiej-Oddzial Hematologii i Transplantacji Szpiku ( Site 1304)
Lublin, Lubelskie 20-090
PolandActive - Recruiting
Pratia MCM Krakow ( Site 1303)
Krakow, Malopolskie 30-727
PolandActive - Recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( S
Warszawa, Mazowieckie 02-781
PolandActive - Recruiting
Szpitale Pomorskie Sp. z o. o.-Hematology and Bone Marrow Transplantation Department ( Site 1302)
Gdynia, Pomorskie 81-519
PolandCompleted
Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku ( Site 1309)
Słupsk, Pomorskie 76-200
PolandActive - Recruiting
Pratia Onkologia Katowice ( Site 1306)
Katowice, Slaskie 40-519
PolandActive - Recruiting
Maharaj Nakorn Chiang Mai Hospital ( Site 0401)
Muang, Chiang Mai 50200
ThailandSite Not Available
Faculty of Medicine Siriraj Hospital-Division of Hematology, Department of Medicine ( Site 0400)
Bangkok, Krung Thep Maha Nakhon 10700
ThailandActive - Recruiting
Chulalongkorn University ( Site 0402)
Pathumwan, Krung Thep Maha Nakhon 10330
ThailandActive - Recruiting
Maharaj Nakorn Chiang Mai Hospital ( Site 0401)
Chiang Mai, 50200
ThailandActive - Recruiting
Ege University Medicine of Faculty ( Site 1902)
Bornova, Izmir 35100
TurkeyActive - Recruiting
Ankara University Hospital Cebeci-hematology ( Site 1901)
Ankara, 06100
TurkeyActive - Recruiting
Mega Medipol-Hematology ( Site 1909)
Istanbul, 34214
TurkeyActive - Recruiting
Dokuz Eylül Üniversitesi-Hematology ( Site 1905)
Izmir, 35340
TurkeyActive - Recruiting
Ondokuz Mayıs Universitesi ( Site 1907)
Samsun, 55139
TurkeyCompleted
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
Institute of Blood Pathology and Transfusion Medicine AMS Ukraine ( Site 2002)
Lviv, Lvivska Oblast 79057
UkraineActive - Recruiting
National Research Center for Radiation Medicine of National Academy of Medical Sciences of Ukraine (
Kyiv, 03115
UkraineActive - Recruiting
Public Non-Profit Enterprise Kyiv City Clinical Hospital #9 under the Executive Body of Kyiv City Co
Kyiv, 04112
UkraineActive - Recruiting
State non-profit enterprise National Cancer Institute ( Site 2001)
Kyiv, 03022
UkraineActive - Recruiting
Aberdeen Royal Infirmary ( Site 2104)
Aberdeen, Aberdeen City AB25 2ZN
United KingdomActive - Recruiting
University College London Hospital-Cancer Clinical Trials Unit ( Site 2100)
London-Camden, London, City Of NW1 2PG
United KingdomActive - Recruiting
Bass Medical Group ( Site 0166)
Walnut Creek, California 94598
United StatesActive - Recruiting
Innovative Clinical Research Institute ( Site 0122)
Whittier, California 90603
United StatesCompleted
Boca Raton Regional Hospital- Lynn Cancer Institute ( Site 0163)
Boca Raton, Florida 33486
United StatesActive - Recruiting
Saint Elizabeth Medical Center Edgewood ( Site 0165)
Edgewood, Kentucky 41017
United StatesActive - Recruiting
University of Kentucky Chandler Medical Center ( Site 0158)
Lexington, Kentucky 40536
United StatesActive - Recruiting
Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0133)
Louisville, Kentucky 40207
United StatesActive - Recruiting
Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0133)
Saint Matthews, Kentucky 40207
United StatesSite Not Available
Louisiana State University Health Sciences Center New Orleans ( Site 0134)
New Orleans, Louisiana 70112
United StatesCompleted
University of Maryland ( Site 0123)
Baltimore, Maryland 21201
United StatesCompleted
Dana-Farber Cancer Institute-Lymphoma ( Site 0111)
Boston, Massachusetts 02215
United StatesActive - Recruiting
University of Massachusetts Medical School ( Site 0119)
Worcester, Massachusetts 01655
United StatesActive - Recruiting
St. Vincent Frontier Cancer Center-Research ( Site 0108)
Billings, Montana 59102
United StatesActive - Recruiting
Atlantic Health System ( Site 0116)
Morristown, New Jersey 07960
United StatesActive - Recruiting
New York Medical College ( Site 0113)
Valhalla, New York 10595
United StatesActive - Recruiting
Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center ( Site 0156)
Nashville, Tennessee 37232
United StatesActive - Recruiting
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