A clinical trial to compare how well glofitamab on its own works versus standard treatment in people with mantle cell lymphoma that has come back after or has not responded to treatment

A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma

  • Cancer
  • Non Hodgkin Lymphoma (NHL)
  • Lymphoma
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Recruiting

This study runs in
Cities
  • Adelaide
  • Alessandria
  • Ann Arbor
  • Barcelona
  • Beijing
  • Bergamo
  • Berkeley
  • Bologna
  • Changchun City
  • Charleston
  • Charlottesville
  • Chengdu City
  • Chesterfield
  • Chongqing
  • Coral Gables
  • Curitiba
  • Cádiz
  • Daejeon
  • Duarte
  • El Paso
  • Fuzhou City
  • Glasgow
  • Guangzhou
  • Indianapolis
  • La Coruna
  • Lille
  • Lincoln
  • London
  • Lund
  • Manchester
  • Milano
  • Montpellier
  • Morgantown
  • Murcia
  • nanning-city
  • Nantes
  • New Brunswick
  • New Haven
  • Ottawa
  • Oxford
  • Paris
  • Plymouth
  • Porto Alegre
  • Richmond
  • Rio de Janeiro
  • Salvador
  • Santa Monica
  • Seoul
  • Shanghai
  • shenyang-city
  • Sioux Falls
  • São Paulo
  • Taipei City
  • Taoyuan
  • The Woodlands
  • Torino
  • Toronto
  • Uppsala län
  • Waratah
  • Wenzhou City
  • Zhengzhou Shi
  • zhengzhou-city
Trial Identifier:

NCT06084936 2023-503206-37-00 GO43878

  • A.O. Città della Salute e della Scienza D - Osp. S. Giov. Battista Molinette

    Recruiting

    88 Corso Bramante10126TorinoItaly
  • Akademiska sjukhuset, Onkologkliniken

    Recruiting

    751 85Uppsala länSweden
  • Alta Bates Summit Medical Center

    Recruiting

    2001 Dwight Way94704BerkeleyUnited States
  • Americas Medical City

    Recruiting

    550 Av. Jorge Curi22775-001Rio de JaneiroBrazil
  • Avera Cancer Institute

    Recruiting

    1000 E 23rd St57105Sioux FallsUnited States
  • Beijing Tong Ren Hospital, Capital Medical University

    Recruiting

    100730BeijingChina
  • Beneficencia Portuguesa de Sao Paulo

    Recruiting

    637 R. Maestro Cardim01321-00São PauloBrazil
  • Calvary Mater Newcastle

    Recruiting

    2298WaratahAustralia
  • Chang Gung Medical Foundation - Linkou

    Recruiting

    259號 Wenhua 1st Rd333TaoyuanTaiwan
  • Chongqing Cancer Hospital

    Recruiting

    181 Han Yu Lu400030ChongqingChina
  • Christie Hospital Nhs Trust

    Recruiting

    M2O 4BXManchesterUnited Kingdom
  • CHU NANTES - Hôtel Dieu

    Recruiting

    1 Pl. Alexis-Ricordeau44093NantesFrance
  • City of Hope Cancer Center

    Recruiting

    1500 E Duarte Rd91010DuarteUnited States
  • Complejo Hospitalario Universitario A Coruña (CHUAC)

    Recruiting

    84 Xubias15006La CorunaSpain
  • Derriford Hospital

    Recruiting

    PL6 8DHPlymouthUnited Kingdom
  • Epworth Hospital

    Recruiting

    89 Bridge Rd3121RichmondAustralia
  • Fujian Provincial Cancer Hospital

    Recruiting

    350014Fuzhou CityChina
  • Guangxi Cancer Hospital of Guangxi Medical University

    Recruiting

    6 Shuang Yong Lu530021nanning-cityChina
  • Henan Cancer Hospital

    Recruiting

    127 北127450008zhengzhou-cityChina
  • Hopital Claude Huriez

    Recruiting

    59037LilleFrance
  • Hopital Necker

    Recruiting

    75743ParisFrance
  • Hopital Saint Eloi

    Recruiting

    80 Av. Augustin Fliche34295MontpellierFrance
  • Hospital A. C. Camargo

    Recruiting

    134 R. Prof. Antônio Prudente01509-010São PauloBrazil
  • Hospital Alemao Oswaldo Cruz

    Recruiting

    1815 R. Treze de Maio01327-001São PauloBrazil
  • Hospital Clinic de Barcelona

    Recruiting

    170 Carrer de Villarroel08036BarcelonaSpain
  • Hospital General Universitario J.M Morales Meseguer

    Recruiting

    s/n Av. Marqués de Los Vélez30008MurciaSpain
  • Hospital Mae de Deus

    Recruiting

    286 R. José de Alencar90110-000Porto AlegreBrazil
  • Hospital Paulistano

    Recruiting

    741 R. Martiniano de Carvalho01321-000São PauloBrazil
  • Hospital Sao Rafael - HSR

    Recruiting

    2152 Av. São Rafael41253-190SalvadorBrazil
  • Hospital Universitari Vall d'Hebron

    Recruiting

    119 Pg. de la Vall d'Hebron08035BarcelonaSpain
  • Hospital Universitario Puerta del Mar

    Recruiting

    21 Av. Ana de Viya11009CádizSpain
  • Humanitas Gavazzeni

    Recruiting

    21 Via Mauro Gavazzeni24121BergamoItaly
  • ICTR Curitiba

    Recruiting

    870 Rua Myltho Anselmo da Silva80510-130CuritibaBrazil
  • Indiana University

    Recruiting

    420 University Blvd46202IndianapolisUnited States
  • INSTITUT CURIE_SITE PARIS - Service d'Oncologie Médicale.

    Recruiting

    57 Rue Fondary75005ParisFrance
  • Instituto D'Or Pesquisa e Ensino

    Recruiting

    662-1500 Av. República do Líbano04502-001São PauloBrazil
  • Irccs Istituto Europeo Di Oncologia (IEO)

    Recruiting

    435 Via Giuseppe Ripamonti20141MilanoItaly
  • Lincolnshire County Hospital

    Recruiting

    LN2 5QYLincolnUnited Kingdom
  • Medical University of S. Carolina

    Recruiting

    29425CharlestonUnited States
  • National Taiwan Universtiy Hospital

    Recruiting

    1 Section 4, Roosevelt Rd100Taipei CityTaiwan
  • NHS Greater Glasgow and Clyde

    Recruiting

    1055 Great Western RdG12 0YNGlasgowUnited Kingdom
  • Oxford Churchill Hospital

    Recruiting

    OX3 7LEOxfordUnited Kingdom
  • Princess Margaret Cancer Center

    Recruiting

    610 University AveM5G 2M9TorontoCanada
  • Renovatio Clinical

    Recruiting

    77380The WoodlandsUnited States
  • Renovatio Clinical - El Paso

    Recruiting

    1400 George Dieter Dr79915El PasoUnited States
  • Royal Adelaide Hospital

    Recruiting

    5000AdelaideAustralia
  • Rutgers Cancer Institute of New Jersey

    Recruiting

    195 Little Albany St08901New BrunswickUnited States
  • SC Ematologia, AO SS. Antonio e Biagio e C. Arrigo

    Recruiting

    15121AlessandriaItaly
  • Skånes University Hospital, Skånes Department of Onclology

    Recruiting

    221 85LundSweden
  • St. Luke's Hospital

    Recruiting

    232 S Woods Mill Rd63017ChesterfieldUnited States
  • The First Affiliated Hospital of China Medical University

    Recruiting

    110001shenyang-cityChina
  • The First Affiliated Hospital of Zhengzhou University

    Recruiting

    1 Jian She Dong Lu450003Zhengzhou ShiChina
  • The First Hospital of Jilin University

    Recruiting

    3808 Jie Fang Da Lu130021Changchun CityChina
  • The Ottawa Hospital - General Campus

    Recruiting

    501 Smyth RdK1H 8L6OttawaCanada
  • University College London Hospital

    Recruiting

    235 Euston Rd.NW1 2PGLondonUnited Kingdom
  • University of California Los Angeles (UCLA) - Cancer Care - Santa Monica

    Recruiting

    90404-2023Santa MonicaUnited States
  • University of Miami

    Recruiting

    1320 S Dixie Hwy33146Coral GablesUnited States
  • University of Michigan Health System

    Recruiting

    1500 E Medical Center Dr48109Ann ArborUnited States
  • University of Virginia

    Recruiting

    22906CharlottesvilleUnited States
  • Victoria Hospital - London Health Sciences Centre

    Recruiting

    800 Commissioners Rd EN6A 5W9LondonCanada
  • West Virginia University

    Recruiting

    26506MorgantownUnited States
  • Yale Cancer Center

    Recruiting

    333 Cedar St06520New HavenUnited States
  • Asan Medical Center

    Active, not recruiting

    05505SeoulKorea, Republic of
  • Fudan University Shanghai Cancer Center

    Active, not recruiting

    270号 Dong An Lu200032ShanghaiChina
  • Policlinico S.Orsola-Malpighi

    Active, not recruiting

    9 Via Giuseppe Massarenti40138BolognaItaly
  • Samsung Medical Center

    Active, not recruiting

    135-710SeoulKorea, Republic of
  • Seoul National University Hospital

    Active, not recruiting

    03080SeoulKorea, Republic of
  • Severance Hospital, Yonsei University Health System

    Active, not recruiting

    003-722SeoulKorea, Republic of
  • Sun yat-sen University Cancer Center

    Active, not recruiting

    651 Dong Feng Dong Lu510060GuangzhouChina
  • The First Affiliated Hospital of Wenzhou Medical University

    Active, not recruiting

    325035Wenzhou CityChina
  • West China Hospital of Sichuan University

    Active, not recruiting

    37 Guo Xue Xiang610041Chengdu CityChina
  • Chungnam National University Hospital

    Withdrawn

    35015DaejeonKorea, Republic of
    Show study locations

    The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

    The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

    Results Disclaimer

    Study Summary

    The purpose of this study is to evaluate the efficacy of glofitamab monotherapy compared with an investigator's choice of either rituximab plus bendamustine (BR), or lenalidomide with rituximab (R-Len) in patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL).

    Hoffmann-La Roche Sponsor
    Phase 3 Phase
    NCT06084936, GO43878, 2023-503206-37-00 Study Identifier
    All Gender
    ≥18 Years Age
    No Healthy Volunteers

    1. Why is the GO43878 clinical trial needed?

    Mantle cell lymphoma (MCL) is a rare type of cancer that starts in white blood cells called lymphocytes. Lymphocytes help protect the body from infection. They travel around the body through a network known as the lymphatic system. This includes the spleen, thymus, tonsils, and beanshaped glands called lymph nodes. In MCL, lymphocytes called B cells become abnormal and cannot fight infections. Abnormal B cells collect in the lymph nodes and spleen. This causes lymph nodes to swell and form cancerous tumours. The standard treatments for MCL include so-called ‘systemic’ treatments such as chemotherapy (for example, bendamustine, or B), immunotherapy (medicines that help the body to use its immune system to fight the cancer) and targeted therapy (treatment that affects only the cancer cells so that healthy cells have less risk of being harmed) such as lenalidomide (Len), rituximab (R) and BTK inhibitors. But MCL often does not respond to treatment (known as ‘refractory’ disease) or comes back after treatment (known as ‘relapsed’ disease). Stem cell transplant is a cure, but people with MCL are rarely well enough to be given this procedure. New treatments are needed for people with relapsed/refractory MCL. Glofitamab is an experimental drug (health authorities have not approved it for treating MCL). It attaches to a protein called CD20 found on some types of MCL cells and can join to another protein on cancer-killing immune system cells. This brings them closer together, so immune cells destroy the MCL cells. This clinical trial aims to compare how well glofitamab works versus standard treatment (BR or R-Len) in people with relapsed/refractory MCL.

    2. How does the GO43878 clinical trial work?

    This clinical trial is recruiting people with relapsed/refractory MCL. People can take part if they have been given at least one treatment including a BTK inhibitor and systemic treatment combination. People who take part in this clinical trial (participants) will be given glofitamab (for up to about 9 months) or the doctors choice of BR (for up to 6 months) or R-Len (for as long it can help them). Treatment will be stopped if cancer gets worse; participants can then choose to swap from BR or R-Len to glofitamab treatment. The clinical trial doctor will see them regularly - at least every 3–4 weeks. Participants will also be seen 6 weeks and 3 months after the final dose of treatment. These hospital/clinical trial doctor visits will include checks to see how participants respond to treatment and any side effects they may have. The total time in the clinical trial will be from 7 months to over 2 years, plus a follow-up every 3 months for as long as the participant agrees. Participants can stop trial treatment and leave the trial at any time.

    3. What are the main endpoints of the GO43878 clinical trial? 

    The main clinical trial endpoints (the main results measured in the trial to see if the drug has worked) is the length of time between the start of the trial and participants’ cancer getting worse (known as ‘progression-free survival’, or PFS). The other clinical trial endpoints include: 

    • How many participants’ have no signs of cancer after treatment (complete response rate)
    • How many participants’ tumours get smaller or disappear after treatment (objective response rate)
    • How long participants live (overall survival)
    • Changes in health-related quality of life

    4. Who can take part in this clinical trial? 

    People can take part in this trial if they are at least 18 years old and have relapsed/refractory MCL. People may not be able to take part in this trial if they have: 

    • Previously received certain treatments, including glofitamab or if they can have, or already had, a stem cell transplant
    • Cancer that has spread to the brain or spinal cord
    • Certain other medical conditions such as heart, liver or auto-immune disease, infections, pregnancy or breastfeeding, or people planning to conceive during the trial or up to a year after the final dose of treatment (depending on which treatment is given). People must also not donate/store sperm or eggs during these periods. 

    5. What treatment will participants be given in this clinical trial?  

    Everyone who joins this clinical trial will be split into two groups randomly (like flipping a coin) and given treatment as an infusion (into a vein) of either glofitamab (experimental group) every 3 weeks (called treatment ‘cycles’) for up to 12 cycles, or the doctors choice of BR or R-Len (control group) every 4 weeks. BR will be given for up to 6 cycles and R-Len will be given for as long it can benefit participants. Participants will have an equal chance of being placed in either the experimental group or the control group. If a participant experiences a potential side effect called ‘cytokine release syndrome’ (when the body’s immune cells are activated and release large amounts of inflammatory substances throughout the body), they may receive another medicine called tocilizumab. Before being given glofitamab for the first time, participants will be given another drug called obinutuzumab, to reduce the risk of side effects. This is an open-label trial, which means everyone involved, including the participant and the clinical trial doctor, will know the clinical trial treatment the participant has been given.

    6. Are there any risks or benefits in taking part in this clinical trial? 

    The safety or effectiveness of the experimental treatment or use may not be fully known at the time of the trial. Most trials involve some risks to the participant. However, it may not be greater than the risks related to routine medical care or the natural progression of the health condition. People who would like to participate will be told about any risks and benefits of taking part in the clinical trial, as well as any additional procedures, tests, or assessments they will be asked to undergo. All of these will be described in an informed consent document (a document that provides people with the information they need to decide to volunteer for the clinical trial).

    Risks associated with the clinical trial drugs
    Participants may have side effects (an unwanted effect of a medical treatment) from the drugs used in this clinical trial. Side effects can be mild to severe, even life-threatening, and vary from person to person. Participants will be closely monitored during the clinical trial; safety assessments will be performed regularly. Participants will be told about the known side effects of bendamustine glofitamab, lenalidomide, obinutuzumab, rituximab and tocilizumab and possible side effects based on laboratory studies or knowledge of similar drugs. Bendamustine, glofitamab, obinutuzumab, rituximab and tocilizumab will be given as infusions into a vein (intravenous infusions); lenalidomide will be given as a tablet (to be swallowed). Participants will be told about any known side effects of intravenous infusions and swallowing tablets. 

    Potential benefits associated with the clinical trial
    Participants' health may or may not improve from participation in the clinical trial. Still, the information collected may help other people with similar medical conditions in the future.

    Study Summary

    The purpose of this study is to evaluate the efficacy of glofitamab monotherapy compared with an investigator's choice of either rituximab plus bendamustine (BR), or lenalidomide with rituximab (R-Len) in patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL).

    Hoffmann-La Roche Sponsor
    Phase 3 Phase
    NCT06084936, GO43878, 2023-503206-37-00 Trial Identifier
    Obinutuzumab, Glofitamab, Rituximab, Bendamustine, Lenalidomide, Tocilizumab Treatments
    Lymphoma Condition
    Official Title

    A Phase III, Open-Label, Multicenter Randomized Study Evaluating Glofitamab as a Single Agent Versus Investigator's Choice in Patients With Relapsed/Refractory Mantle Cell Lymphoma

    Eligibility Criteria

    All Gender
    ≥18 Years Age
    No Healthy Volunteers
    Inclusion Criteria
    • Life expectancy at least 12 weeks
    • Histologically-confirmed MCL, with documentation of either overexpression of cyclin D1 or the presence of t(11:14)
    • Relapsed (disease progression after the last treatment regimen) or refractory (failure to achieve a partial or complete response from the last treatment regimen) disease
    • At least 1 line of prior systemic therapy including a BTK inhibitor and additional systemic therapy option
    • Confirmed availability of tumor tissue, unless deemed unsafe per investigator assessment
    • At least one bi-dimensionally measurable (defined as at least 1.5 cm) nodal lesion, or one bi-dimensionally measurable (at least 1 cm) extranodal lesion, as measured on CT scan
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
    • Negative HIV test at screening
    • Adequate hematological function
    Exclusion Criteria
    • Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final dose of tocilizumab, 2 months after the final dose of glofitamab, whichever is longer
    • Leukemic, non-nodal MCL
    • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products
    • Contraindication to obinutuzumab or rituximab, and either bendamustine or lenalidomide
    • Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3
    • Prior treatment with CAR-T cell therapy
    • Treatment with systemic therapy or BTK inhibitors, or any investigational agent for the purposes of treating cancer within 2 weeks or 5 half-lives (whichever is shorter) prior to first study treatment
    • Primary or secondary CNS lymphoma at the time of recruitment or history of CNS lymphoma
    • Current or history of CNS disease, such as stroke, epilepisy, CNS vasculitis, or neurodegenerative disease
    • History of other malignancy that could affect compliance with the protocol or interpretation of results
    • Significant or extensive cardiovascular disease
    • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at study enrollment or any major episode of infection within 4 weeks prior to the first study treatment
    • Suspected or latent tuberculosis
    • Positive test for hepatitis B virus (HBV) or hepatitis C virus (HCV)
    • Known or suspected chronic active Epstein-Barr viral infection (EBV)
    • Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
    • Known history of progressive multifocal leukoencephalopathy (PML)
    • Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or better
    • Administration of a live, attenuated vaccine within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study
    • Prior solid organ transplantation or allogenic stem cell transplant
    • Eligibility for stem cell transplantation (SCT)
    • Active autoimmune disease requiring treatment
    • Prior treatment with systemic immunosuppressive medications within 2 weeks or five half-lives (whichever is shorter) prior to the first dose of study treatment
    • Corticosteroid therapy within 2 weeks prior to first dose of study treatment
    • Recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis
    • Clinically significant history of cirrhotic liver disease

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