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New hope for hard-to-treat lymphoma: drug duo aims to shrink tumors and delay progression

NCT ID NCT05171647

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 06, 2026 · Updated 2 times

Summary

This phase 3 study tests whether a combination of two targeted drugs (mosunetuzumab and polatuzumab vedotin) works better than a standard chemotherapy regimen for people with aggressive B-cell non-Hodgkin lymphoma that has returned or not responded to prior therapy. About 208 adults with certain lymphoma subtypes will be randomly assigned to one of the two treatment groups. The main goals are to see how many patients have their tumors shrink or disappear and how long they live without the cancer getting worse.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

208 people

The number who actually took part.

Started

Apr 2022

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 * 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: * Pregnant or breast feeding, or intending to become pregnant during the study or within 3 months after the final dose of mosunetuzumab, 9 months after the final dose of polatuzumab vedotin, 12 months after the final dose of rituximab, 6 months after the final dose of gemcitabine, 9 months after the final dose of oxaliplatin, and 3 months 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, 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

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Conditions

The condition(s) this trial relates to.

diffuse large B-cell lymphoma follicular lymphoma high grade B-cell lymphoma non-Hodgkin lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-Hodgkin lymphoma

Contacts and locations

Locations

  • Anadolu Health Center

    Kocaeli, 41400, Turkey (Türkiye)

  • Ankara University Medical Faculty

    Ankara, 06100, Turkey (Türkiye)

  • Ascension Seton Infusion Center

    Austin, Texas, 78712, United States

  • Cancer Center, Sun Yat-sen University of Medical Sciences

    Guangzhou, 510060, China

  • Chiang Mai Uni Hospital

    Chiang Mai, 50200, Thailand

  • Chum Hopital Notre Dame

    Montreal, Quebec, H2L 4M1, Canada

  • Chungnam National University Hospital

    Daejeon, 35015, South Korea

  • City of Hope Cancer Center

    Duarte, California, 91010, United States

  • D'or Instituto de Pesquisa e Educação

    São Paulo, Brazil

  • Dokuz Eylul Universitesi Tip Fakultesi

    Lzmir, 35340, Turkey (Türkiye)

  • FUNDALEU

    Buenos Aires, C1114AAN, Argentina

  • Fujian Medical University Union Hospital

    Fuzhou, 350001, China

  • Hamilton Health Sciences - Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2, Canada

  • Henan Cancer Hospital

    Zhengzhou, 450008, China

  • Hokkaido University Hospital

    Hokkaido, 060-8648, Japan

  • Hospital Aleman

    Buenos Aires, 1118, Argentina

  • Hospital Erasto Gaertner

    Curitiba, Paraná, 81520-060, Brazil

  • Hospital Italiano de Buenos Aires

    Ciudad Autonoma Buenos Aires, C1181ACH, Argentina

  • Hospital Sao Jose

    São Paulo, São Paulo, 01323-030, Brazil

  • Hospital Universitario Dr. Jose E. Gonzalez

    Monterrey, Nuevo León, 64460, Mexico

  • Hospital das Clinicas - UFRGS

    Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

  • Hospital das Clínicas FMRP-USP

    Ribeirão Preto, São Paulo, 14048-900, Brazil

  • Ichilov Sourasky Medical Center

    Tel Aviv, 6423906, Israel

  • Instituto Alexander Fleming

    Buenos Aires, 1426, Argentina

  • Instituto Nacional de Cancerologia

    Distrito Federal, 14080, Mexico

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    México, Mexico

  • Instituto Regional de Enfermedades Neoplásicas del Sur

    Arequipa, 5154, Peru

  • Kindai University Hospital

    Osaka, 589-8511, Japan

  • Kyushu University Hospital

    Fukuoka, 812-8582, Japan

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Medipol Mega Üniversite Hastanesi Göztepe

    Istanbul, 34214, Turkey (Türkiye)

  • Middlemore Clinical Trials

    Auckland, New Zealand

  • Oncosalud Sac

    Lima, 41, Peru

  • Ondokuz Mayis Univ. Med. Fac.

    Samsun, 55139, Turkey (Türkiye)

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9, Canada

  • Pusan National University Hospital

    Busan, 49241, South Korea

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Sichuan Cancer Hospital

    Chengdu, 610041, China

  • Siriraj Hospital

    Bangkok, 10700, Thailand

  • Soroka Medical Center

    Beersheba, 8410101, Israel

  • Srinagarind Hospital, Khon Kaen Uni

    Khon Kaen, 40002, Thailand

  • St. Luke's Hospital

    Chesterfield, Missouri, 63017, United States

  • Superare Centro de Infusion S.A. de C.V.

    Mexico City, Mexico CITY (federal District), 11550, Mexico

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550, Japan

  • Tianjin Cancer Hospital

    Tianjin, 300060, China

  • Tohoku University Hospital

    Miyagi, 980-8574, Japan

  • Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech

    Wuhan, 430030, China

  • Yamagata University Hospital

    Yamagata, 990-9585, Japan

  • Yeouido St. Mary's Hospital

    Seoul, 07345, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.