A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin Compared to Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma
NCT ID: NCT05171647
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
242 participants
INTERVENTIONAL
2022-04-25
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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M+P (Arm A)
Participants will receive subcutaneous (SC) mosunetuzumab plus intravenous (IV) polatuzumab vedotin (M+P). Mosunetuzumab will be administered on Days 1, 8, and 15 of Cycle 1, and thereafter on Day 1 of Cycles 2-8. Polatuzumab vedotin will be administered on Day 1 of each cycle up to Cycle 6. Cycle length = 21 days.
Mosunetuzumab
Participants will receive SC mosunetuzumab on Days 1, 8, and 15 of Cycle 1, and on Day 1 of Cycles 2-8 (cycle length = 21 days).
Polatuzumab vedotin
Participants will receive IV polatuzumab vedotin every three weeks (Q3W) for 6 cycles (cycle length = 21 days).
Tocilizumab
Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) events.
R-GemOx (Arm B)
Participants will receive IV rituximab, IV gemcitabine, and IV oxaliplatin (R-GemOx) on Day 1 of each cycle for 8 cycles. Cycle length = 14 days.
Rituximab
Participants will receive IV rituximab on Day 1 of each cycle for 8 cycles (cycle length = 14 days).
Gemcitabine
Participants will receive IV gemcitabine on Day 1 of each cycle for 8 cycles (cycle length = 14 days).
Oxaliplatin
Participants will receive IV oxaliplatin on Day 1 of each cycle for 8 cycles (cycle length = 14 days).
Interventions
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Mosunetuzumab
Participants will receive SC mosunetuzumab on Days 1, 8, and 15 of Cycle 1, and on Day 1 of Cycles 2-8 (cycle length = 21 days).
Polatuzumab vedotin
Participants will receive IV polatuzumab vedotin every three weeks (Q3W) for 6 cycles (cycle length = 21 days).
Tocilizumab
Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) events.
Rituximab
Participants will receive IV rituximab on Day 1 of each cycle for 8 cycles (cycle length = 14 days).
Gemcitabine
Participants will receive IV gemcitabine on Day 1 of each cycle for 8 cycles (cycle length = 14 days).
Oxaliplatin
Participants will receive IV oxaliplatin on Day 1 of each cycle for 8 cycles (cycle length = 14 days).
Eligibility Criteria
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Inclusion Criteria
* CD20+ aggressive lymphoma as determined by the local hemopathology laboratory from the following diagnoses by 2016 World Health Organization classification of lymphoid neoplasms: DLBCL, not otherwise specified (NOS); high-grade B-cell lymphoma (NOS or double/triple hit); transformed follicular lymphoma; follicular lymphoma Grade 3b
* Have disease relapsed or refractory to at least one prior systemic therapy for aggressive non-Hodgkin's lymphoma (aNHL)
* Participants who have received only one prior line of therapy must be ineligible for autologous stem cell transplant (ASCT)
* Measurable disease
* Adequate hepatic, hematologic, and renal function
* Estimated creatinine clearance (CrCl) ≥ 30 mL/min by Cockroft-Gault method or other institutional standard methods
* Negative HIV test at screening. Participants with a positive HIV test at screening are eligible provided that, prior to enrollment, they are stable on anti-retroviral therapy for at least 4 weeks, have a CD4 count of at least 200 microliters, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months
Exclusion Criteria
* Inability to comply with protocol-mandated activity restrictions
* Prior treatment with mosunetuzumab or other CD-20-directed bispecific antibodies, or R-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 of polatuzumab vedotin; participants who received up to 2 doses of a polatuzumab vedotin-containing regimen as bridging to CAR-T therapy, and either has a documented disease control (stable disease, partial response, or complete response), or were not 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-lymphoma treatment (except for alopecia and anorexia, or other toxicities not considered a safety risk for the participant per investigator's judgment)
* Received anti-lymphoma treatments with monoclonal antibodies, radio-immunoconjugates or antibody-drug conjugates (ADCs) within 4 weeks before the first dose of study treatment
* Treatment with any chemotherapeutic agent, or treatment with any other anti-lymphoma agent (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 study treatment
* ASCT within 100 days prior to the first study treatment administration
* Prior treatment with chimeric antigen receptor (CAR) T cell therapy within 30 days before 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 or interpretation of results, with the exception of malignancies with a negligible risk of 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, or neurodegenerative disease. Participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurologic deficits as judged by the investigator, or with a history of epilepsy who have had no seizures in the past 2 years while not receiving any anti-epileptic medications, are allowed
* Significant cardiovascular disease such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, 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 6 months 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 major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 2 weeks prior to the 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 treatment administration
* 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 first dose of study treatment administration or anticipation that such a live, attenuated vaccine 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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City of Hope Cancer Center
Duarte, California, United States
St. Luke's Hospital
Chesterfield, Missouri, United States
Ascension Seton Infusion Center
Austin, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Hospital Aleman
Buenos Aires, , Argentina
Instituto Alexander Fleming
Buenos Aires, , Argentina
FUNDALEU
Buenos Aires, , Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires, , Argentina
Hospital Erasto Gaertner
Curitiba, Paraná, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, Brazil
Hospital das Clínicas FMRP-USP
Ribeirão Preto, São Paulo, Brazil
Hospital Sao Jose
São Paulo, São Paulo, Brazil
D'or Instituto de Pesquisa e Educação
São Paulo, , Brazil
Hamilton Health Sciences - Juravinski Cancer Centre
Hamilton, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Chum Hopital Notre Dame
Montreal, Quebec, Canada
Sichuan Cancer Hospital
Chengdu, , China
Fujian Medical University Union Hospital
Fuzhou, , China
Cancer Center, Sun Yat-sen University of Medical Sciences
Guangzhou, , China
Tianjin Cancer Hospital
Tianjin, , China
Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
Wuhan, , China
Henan Cancer Hospital
Zhengzhou, , China
Soroka Medical Center
Beersheba, , Israel
Ichilov Sourasky Medical Center
Tel Aviv, , Israel
Kyushu University Hospital
Fukuoka, , Japan
Hokkaido University Hospital
Hokkaido, , Japan
Tohoku University Hospital
Miyagi, , Japan
Kindai University Hospital
Osaka, , Japan
The Cancer Institute Hospital of JFCR
Tokyo, , Japan
Yamagata University Hospital
Yamagata, , Japan
Health Pharma Professional Research
Mexico City, Mexico CITY (federal District), Mexico
Superare Centro de Infusion S.A. de C.V.
Mexico City, Mexico CITY (federal District), Mexico
Hospital Universitario Dr. Jose E. Gonzalez
Monterrey, Nuevo León, Mexico
Instituto Nacional de Cancerologia
Distrito Federal, , Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
México, , Mexico
Middlemore Clinical Trials
Auckland, , New Zealand
Instituto Regional de Enfermedades Neoplásicas del Sur
Arequipa, , Peru
Oncosalud Sac
Lima, , Peru
Pusan National University Hospital
Busan, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Yeouido St. Mary's Hospital
Seoul, , South Korea
Chulalongkorn University Hospital
Bangkok, , Thailand
Siriraj Hospital
Bangkok, , Thailand
Chiang Mai Uni Hospital
Chiang Mai, , Thailand
Srinagarind Hospital, Khon Kaen Uni
Khon Kaen, , Thailand
Ankara University Medical Faculty
Ankara, , Turkey (Türkiye)
Medipol Mega Üniversite Hastanesi Göztepe
Istanbul, , Turkey (Türkiye)
Anadolu Health Center
Kocaeli, , Turkey (Türkiye)
Dokuz Eylul Universitesi Tip Fakultesi
Lzmir, , Turkey (Türkiye)
Countries
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References
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Budde LE, Zhang H, Kim WS, Maruyama D, Rego EM, Norasetthada L, Hong H, Ozcan M, Jeon YW, Cordeiro de Farias DL, Fogliatto LM, Pavlovsky A, Goto H, Olszewski AJ, Shah N, Hu B, Yin S, Wu H, To I, Ead WS, Ashby J, Janousek M, Pham S, Wang J, Kwan A, Batlevi CL, Wei MC, Westin J. Mosunetuzumab plus polatuzumab vedotin in transplant-ineligible refractory/relapsed large B-cell lymphoma: primary results of the phase 3 SUNMO trial. J Clin Oncol. 2025 Oct 2:101200JCO2501957. doi: 10.1200/JCO-25-01957. Online ahead of print.
Other Identifiers
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GO43643
Identifier Type: -
Identifier Source: org_study_id