Phase
Condition
Non-hodgkin's Lymphoma
Hematologic Cancer
Lymphoma, B-cell
Treatment
Oxaliplatin
Tocilizumab
Rituximab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
CD20+ aggressive lymphoma as determined by the local hemopathology laboratory fromthe following diagnoses by 2016 World Health Organization classification of lymphoidneoplasms: DLBCL, not otherwise specified (NOS); high-grade B-cell lymphoma (NOS ordouble/triple hit); transformed follicular lymphoma; follicular lymphoma Grade 3b
Have disease relapsed or refractory to at least one prior systemic therapy foraggressive non-Hodgkin's lymphoma (aNHL)
Participants who have received only one prior line of therapy must be ineligible forautologous stem cell transplant (ASCT)
Measurable disease
Adequate hepatic, hematologic, and renal function
Estimated creatinine clearance (CrCl) ≥ 30 mL/min by Cockroft-Gault method or otherinstitutional standard methods
Negative HIV test at screening. Participants with a positive HIV test at screeningare eligible provided that, prior to enrollment, they are stable on anti-retroviraltherapy for at least 4 weeks, have a CD4 count of at least 200 microliters, have anundetectable viral load, and have not had a history of opportunistic infectionattributable to AIDS within the last 12 months
Exclusion
Exclusion Criteria:
Pregnant or breast feeding, or intending to become pregnant during the study orwithin 3 months after the final dose of mosunetuzumab, 9 months after the final doseof polatuzumab vedotin, 12 months after the final dose of rituximab, 6 months afterthe final dose of gemcitabine, 9 months after the final dose of oxaliplatin, and 3months after the final dose of tocilizumab, as applicable
Inability to comply with protocol-mandated activity restrictions
Prior treatment with mosunetuzumab or other CD-20-directed bispecific antibodies, orR-GemOx or Gem-Ox
Prior treatment with polatuzumab vedotin, with the following exceptions:participants who have a documented response (partial response or complete response)to polatuzumab vedotin and an absence of PD within 12 months from the last dose ofpolatuzumab vedotin; participants who received up to 2 doses of a polatuzumabvedotin-containing regimen as bridging to CAR-T therapy, and either has a documenteddisease control (stable disease, partial response, or complete response), or werenot assessed for response following treatment with polatuzumab vedotin
Contraindication to any component of the study treatment
Grade > 1 peripheral neuropathy
Participants with Grade > 1 persistent toxicity related to prior anti-lymphomatreatment (except for alopecia and anorexia, or other toxicities not considered asafety risk for the participant per investigator's judgment)
Received anti-lymphoma treatments with monoclonal antibodies, radio-immunoconjugatesor antibody-drug conjugates (ADCs) within 4 weeks before the first dose of studytreatment
Treatment with any chemotherapeutic agent, or treatment with any other anti-lymphomaagent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug,whichever is shorter, prior to the first dose of study treatment
Treatment with radiotherapy within 2 weeks prior to the first dose of studytreatment
ASCT within 100 days prior to the first study treatment administration
Prior treatment with chimeric antigen receptor (CAR) T cell therapy within 30 daysbefore the first study treatment administration
Prior allogenic stem cell transplant (SCT)
Have had a solid organ transplantation
Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
History of confirmed progressive multifocal leukoencephalopathy
History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombination antibody-related fusion proteins)
History of other malignancy that could affect compliance with the protocol orinterpretation of results, with the exception of malignancies with a negligible riskof metastasis or death
Currently have or have had a past history of central nervous system (CNS)involvement of lymphoma
Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, orneurodegenerative disease. Participants with a history of stroke who have notexperienced a stroke or transient ischemic attack in the past 2 years and have noresidual neurologic deficits as judged by the investigator, or with a history ofepilepsy who have had no seizures in the past 2 years while not receiving anyanti-epileptic medications, are allowed
Significant cardiovascular disease such as New York Heart Association Class III orIV cardiac disease, myocardial infarction within the last 6 months, unstablearrhythmias, or unstable angina
Significant active pulmonary disease
Participants with active symptoms of interstitial lung disease and/or pneumonitis,or those with a history of interstitial lung disease and/or pneumonitis within 6months prior to the first dose of study treatment
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of the nail beds) at study enrollment, or any majorepisode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 2 weeks prior tothe first study treatment administration
Known or suspected chronic active Epstein-Barr virus (EBV) infection
Recent major surgery within 4 weeks prior to the first study treatmentadministration
Positive test results for chronic hepatitis B infection
Acute or chronic hepatitis C virus (HCV) infection
Have been administered a live, attenuated vaccine within 4 weeks before the firstdose of study treatment administration or anticipation that such a live, attenuatedvaccine will be required during the study
Participants who have positive SARS-CoV-2 test within 7 days prior to enrollment (rapid antigen test result is acceptable)
History of autoimmune disease
Received investigational therapy, whether or not intended for lymphoma treatment,within 7 days prior to initiation of study treatment
Clinically significant history of liver disease, including viral or other hepatitis,or cirrhosis
Study Design
Connect with a study center
FUNDALEU
Buenos Aires, C1114AAN
ArgentinaSite Not Available
Fundaleu; Haematology
Buenos Aires, C1114AAN
ArgentinaSite Not Available
Hospital Aleman
Buenos Aires, 1118
ArgentinaSite Not Available
Instituto Alexander Fleming
Buenos Aires, 1426
ArgentinaSite Not Available
Hospital Aleman
Ciudad Autonoma Buenos Aires, C1118AAT
ArgentinaSite Not Available
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires, C1181ACH
ArgentinaSite Not Available
Hospital Italiano de Buenos Aires
Ciudad Autónoma de Buenos Aires, C1181ACH
ArgentinaSite Not Available
Hospital Erasto Gaertner
Curitiba, Paraná 81520-060
BrazilSite Not Available
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande Do Sul 90035-903
BrazilSite Not Available
D'or Instituto de Pesquisa e Educação
Sao Paulo, SP 04062-001
BrazilSite Not Available
Hospital das Clínicas FMRP-USP
Ribeirao Preto, São Paulo 14048-900
BrazilSite Not Available
Hospital Sao Jose
Sao Paulo, São Paulo 01323-030
BrazilSite Not Available
D'or Instituto de Pesquisa e Educação
São Paulo, 04062-001
BrazilSite Not Available
Hamilton Health Sciences - Juravinski Cancer Centre
Hamilton, Ontario L8V 5C2
CanadaSite Not Available
Princess Margaret Hospital
Toronto, Ontario M5G 2M9
CanadaSite Not Available
Princess Margaret Hospital; Department of Med Oncology
Toronto, Ontario M5G 2M9
CanadaSite Not Available
Chum Hopital Notre Dame
Montreal, Quebec H2L 4M1
CanadaSite Not Available
Chum Hopital Notre Dame; Centre D'Oncologie
Montreal, Quebec H2L 4M1
CanadaSite Not Available
Saskatchewan Cancer Agency (SCA) - Saskatoon Cancer Centre (SCC)
Saskatoon, Saskatchewan S7N 4H4
CanadaSite Not Available
Sichuan Cancer Hospital
Chengdu, 610041
ChinaSite Not Available
Sichuan Cancer Hospital
Chengdu City, 610041
ChinaSite Not Available
Fujian Medical University Union Hospital
Fuzhou, 350001
ChinaSite Not Available
Fujian Medical University Union Hospital
Fuzhou City, 350001
ChinaSite Not Available
Cancer Center, Sun Yat-sen University of Medical Sciences; Department of Medical Oncology
Guangzhou, 510060
ChinaSite Not Available
Cancer Center, Sun Yat-sen University of Medical Sciences
Guangzhou City, 510060
ChinaSite Not Available
Cancer Center, Sun Yat-sen University of Medical Sciences; Department of Medical Oncology
Guangzhou City, 510060
ChinaSite Not Available
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, 310003
ChinaSite Not Available
The Second Affiliated Hospital to Nanchang University
Nanchang, 330006
ChinaSite Not Available
Tianjin Cancer Hospital
Tianjin, 300060
ChinaSite Not Available
Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
Wuhan, 430030
ChinaSite Not Available
Henan Cancer Hospital
Zhengzhou, 450008
ChinaSite Not Available
Soroka Medical Center
Beer Sheva, 8410101
IsraelSite Not Available
Soroka Medical Center; Hematology Deptartment
Beer Sheva, 8410101
IsraelSite Not Available
Meir Medical Center; Heamatology Dept
Kfar Saba, 4428164
IsraelSite Not Available
Ichilov Sourasky Medical Center
Tel Aviv, 6423906
IsraelSite Not Available
Ichilov Sourasky Medical Center; Heamatology
Tel Aviv, 6423906
IsraelSite Not Available
Kyushu University Hospital
Fukuoka, 812-8582
JapanSite Not Available
Hokkaido University Hospital
Hokkaido, 060-8648
JapanSite Not Available
Kobe City Medical Center General Hospital
Hyogo, 650-0047
JapanSite Not Available
Tokai University Hospital
Kanagawa, 259-1193
JapanSite Not Available
Mie University Hospital
Mie, 514-8507
JapanSite Not Available
Tohoku University Hospital
Miyagi, 980-8574
JapanSite Not Available
Kindai University Hospital
Osaka, 589-8511
JapanSite Not Available
The Cancer Institute Hospital of JFCR
Tokyo, 135-8550
JapanSite Not Available
Yamagata University Hospital
Yamagata, 990-9585
JapanSite Not Available
Pusan National University Hospital
Busan, 49241
Korea, Republic ofSite Not Available
Chungnam National University Hospital
Daejeon, 35015
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, 06351
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Severance Hospital, Yonsei University Health System
Seoul, 03722
Korea, Republic ofSite Not Available
Yeouido St. Mary's Hospital
Seoul, 07345
Korea, Republic ofSite Not Available
Health Pharma Professional Research
Cdmx, Mexico CITY (federal District) 03100
MexicoSite Not Available
Health Pharma Professional Research
Ciudad de México, Mexico CITY (federal District) 03100
MexicoSite Not Available
Superare Centro de Infusion S.A. de C.V.
Ciudad de México, Mexico CITY (federal District) 11550
MexicoSite Not Available
Superare Centro de Infusion S.A. de C.V.
Mexico, Mexico CITY (federal District) 06760
MexicoSite Not Available
Hospital Universitario Dr. Jose E. Gonzalez
Monterrey, Nuevo LEON 64460
MexicoSite Not Available
Hospital Universitario Dr. Jose E. Gonzalez; Haematology
Monterrey, Nuevo LEON 64460
MexicoSite Not Available
Instituto Nacional de Cancerologia
Distrito Federal, 14080
MexicoSite Not Available
Instituto Nacional de Cancerologia; Oncology
Distrito Federal, 14080
MexicoSite Not Available
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico,
MexicoSite Not Available
Instituto Nacional de Cancerologia; Oncology
Mexico City, 14080
MexicoSite Not Available
Middlemore Clinical Trials
Auckland,
New ZealandSite Not Available
Instituto Regional de Enfermedades Neoplásicas del Sur
Arequipa, 5154
PeruSite Not Available
Instituto Regional de Enfermedades Neoplásicas del Sur; Centro de Inv. de Medicina Oncológica
Arequipa, 5154
PeruSite Not Available
Hospital Nacional Edgardo Rebagliati Martins, Servicio de Gastroenterologia
Lima, 11
PeruSite Not Available
Instituto Nacional de Enfermedades Neoplasicas
Lima, 15038
PeruSite Not Available
Oncosalud Sac
Lima, 41
PeruSite Not Available
Oncosalud Sac; Oncología
Lima, 41
PeruSite Not Available
Hospital De Alta Complejidad Virgen De La Puerta - Essalud; Oncology
Trujillo, 13013
PeruSite Not Available
Regional Clinical Hospital N.A. Semashko; Hematology
Nizhny Novgorod, Niznij Novgorod 603126
Russian FederationSite Not Available
Blokhin Cancer Research Center; Clinical Oncology
Moscow, 115478
Russian FederationSite Not Available
Penza Regional Oncology Dispensary
Penza, 440071
Russian FederationSite Not Available
St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta
Saint-Petersburg, 197022
Russian FederationSite Not Available
Chulalongkorn University Hospital
Bangkok, 10330
ThailandSite Not Available
Chulalongkorn University Hospital; Hematology
Bangkok, 10330
ThailandSite Not Available
Siriraj Hospital
Bangkok, 10700
ThailandSite Not Available
Siriraj Hospital; Division of Hematology, Department of Medicine
Bangkok, 10700
ThailandSite Not Available
Chiang Mai Uni Hospital
Chiang Mai, 50200
ThailandSite Not Available
Chiang Mai Uni Hospital; Division of Hematology,Dept of Medicine,Faculty of Medicine
Chiang Mai, 50200
ThailandSite Not Available
Srinagarind Hospital, Khon Kaen Uni
Khon Kaen, 40002
ThailandSite Not Available
Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine
Khon Kaen, 40002
ThailandSite Not Available
Chulalongkorn University Hospital; Hematology
Pathum Wan, 10330
ThailandSite Not Available
Ankara University Medical Faculty
Ankara, 06100
TurkeySite Not Available
Medipol Mega Üniversite Hastanesi Göztepe
Istanbul, 34214
TurkeySite Not Available
Dokuz Eylul Universitesi Tip Fakultesi
Izmir, 35340
TurkeySite Not Available
Anadolu Health Center
Kocaeli, 41400
TurkeySite Not Available
Anadolu Health Center; Heamathology Department
Kocaeli, 41400
TurkeySite Not Available
Dokuz Eylul Universitesi Tip Fakultesi
Lzmir, 35340
TurkeySite Not Available
Ondokuz Mayis Univ. Med. Fac.
Samsun, 55139
TurkeySite Not Available
Alaska Oncology & Hematology, LLC
Anchorage, Alaska 99508
United StatesSite Not Available
Ironwood cancer and research center
Chandler, Arizona 85224
United StatesSite Not Available
City of Hope Cancer Center
Duarte, California 91010
United StatesSite Not Available
City of Hope Cancer Center; Division of Medical Oncology & Experimental Therapeutics
Duarte, California 91010
United StatesSite Not Available
Kaiser Permanente - Irvine
Irvine, California 92618
United StatesSite Not Available
Cancer Blood and Specialty Clinic
Los Alamitos, California 90720
United StatesSite Not Available
USC School of Medicine
Los Angeles, California 90033
United StatesSite Not Available
University of Miami - Clinical Research Services
Miami, Florida 33136
United StatesSite Not Available
Investigative Clinical Research of Indiana, LLC
Noblesville, Indiana 46062
United StatesSite Not Available
St. Luke's Hospital
Chesterfield, Missouri 63017
United StatesSite Not Available
Levine Cancer Institute - Clincal Trials Administration
Charlotte, North Carolina 28204
United StatesSite Not Available
Rhode Island Hospital; Comprehensive Cancer Center
Providence, Rhode Island 02903
United StatesSite Not Available
Ascension Seton Infusion Center
Austin, Texas 78712
United StatesSite Not Available
MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
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