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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified April 2026 by Hoffmann-La Roche
Sponsor
Hoffmann-La Roche
Information Provided by (Responsible Party)
Hoffmann-La Roche
Clinicaltrials.gov Identifier
NCT06084936
Other Study ID Numbers:
GO43878
First Submitted
September 13, 2023
First Posted
October 15, 2023
Last Update Posted
May 3, 2026
Last Verified
April 2026

ClinicalTrials.gov processed this data on April 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Lymphoma
Drug: ObinutuzumabDrug: Rituximab

Study Design

Study TypeInterventional
Actual Enrollment182 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA 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
Study Start DateOctober 21, 2023
Actual Primary Completion Date1yr 3mos from now
Actual Study Completion Date1yr 10mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Glofitamab monotherapy
Participants will receive two intravenous (IV) obinutuzumab pretreatments prior to receiving IV glofitamab for 12 cycles (cycle length = 21 days).
Drug: Obinutuzumab
Participants will receive two 1000 mg pretreatments of intravenous (IV) obinutuzumab from Cycle 1 Day 1
BR or R-Len
Participants will receive bendamustine + rituximab for up to 6 cycles (cycle length = 28 days), or rituximab + lenalidomide (cycle length = 28 days) until disease progression.
Drug: Rituximab
Participants will receive IV rituximab every 28 days for up to 6 cycles (when in combination with bendamustine), or until disease progression (when in combination with lenalidomide).

Outcome Measures

Primary Outcome Measures
  1. Progression-free survival (PFS)
Secondary Outcome Measures
  1. Complete response (CR) rate
  2. Objective response rate (ORR)
  3. Overall survival (OS)
  4. Time to deterioration in physical functioning/fatigue
  5. Investigator-assessed PFS
  6. Investigator-assessed CR rate
  7. Investigator-assessed ORR
  8. Duration of Complete Response (DOCR)
  9. Duration of Response (DOR)
  10. Proportion of participants reporting each response option for item GP5 from the Functional Assessment of Cancer Therapy - General (FACT-G) subscale
  11. Time to deterioration in lymphoma symptoms
  12. Proportion of participants experiencing a clinically meaningful improvement (3-point or more increase) in lymphoma symptoms as assessed through use of the FACT-Lym LymS
  13. Change from baseline in physical functioning and fatigue at each cycle as assessed by the European Organization for Research and Treatment (EORTC) core Quality of Life Questionnaire (QLQ-C30)
    The EORTC QLQ-C30 consists of 30 questions assessing five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), global health status and quality of life (QoL), and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The functioning and symptoms items are scored on a 4-point scale that ranges from "not at all" to "very much," and the global health status and QoL items are scored on a 7-point scale that ranges from "very poor" to "excellent."
  14. Change from baseline in lymphoma symptoms at each cycle as assessed by the FACT-Lym LymS
  15. Serum concentration of glofitamab
  16. Incidence of anti-drug antibodies (ADAs)

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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) within 12 months of study entry
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

Contacts and Locations

Sponsors and CollaboratorsHoffmann-La Roche
Locations
Alta Bates Summit Medical Center | Berkeley California, United States, 94704City of Hope Cancer Center | Duarte California, United States, 91010University of California Los Angeles (UCLA) - Cancer Care - Santa Monica | Santa Monica California, United States, 90404-2023Yale Cancer Center | New Haven Connecticut, United States, 06520Georgetown University | Washington D.C. District of Columbia, United States, 20007University of Miami | Coral Gables Florida, United States, 33146Indiana University | Indianapolis Indiana, United States, 46202University of Michigan Health System | Ann Arbor Michigan, United States, 48109St. Luke's Hospital | Chesterfield Missouri, United States, 63017Renown Regional Medical Center | Reno Nevada, United States, 89502Rutgers Cancer Institute of New Jersey | New Brunswick New Jersey, United States, 08901University of Rochester | Rochester New York, United States, 14642Medical University of S. Carolina | Charleston South Carolina, United States, 29425Avera Cancer Institute | Sioux Falls South Dakota, United States, 57105Renovatio Clinical - El Paso | El Paso Texas, United States, 79915Renovatio Clinical | The Woodlands Texas, United States, 77380University of Virginia | Charlottesville Virginia, United States, 22906West Virginia University | Morgantown West Virginia, United States, 26506Calvary Mater Newcastle | Waratah New South Wales, Australia, 2298Royal Adelaide Hospital | Adelaide South Australia, Australia, 5000Epworth Hospital | Richmond Victoria, Australia, 3121Hospital Sao Rafael - HSR | Salvador Estado de Bahia, Brazil, 41253-190ICTR Curitiba | Curitiba Paraná, Brazil, 80510-130Hospital Mae de Deus | Porto Alegre Rio Grande do Sul, Brazil, 90110-000Hospital Paulistano | São Paulo São Paulo, Brazil, 01321-000Hospital Alemao Oswaldo Cruz | São Paulo São Paulo, Brazil, 01327-001Hospital A. C. Camargo | São Paulo São Paulo, Brazil, 01509-010Instituto D'Or Pesquisa e Ensino | São Paulo São Paulo, Brazil, 04502-001Americas Medical City | Rio de Janeiro , Brazil, 22775-001Beneficencia Portuguesa de Sao Paulo | São Paulo , Brazil, 01321-00Victoria Hospital - London Health Sciences Centre | London Ontario, Canada, N6A 5W9The Ottawa Hospital - General Campus | Ottawa Ontario, Canada, K1H 8L6Princess Margaret Cancer Center | Toronto Ontario, Canada, M5G 2M9Beijing Tong Ren Hospital, Capital Medical University | Beijing , China, 100730The First Hospital of Jilin University | Changchun , China, 130021West China Hospital of Sichuan University | Chengdu , China, 610041Chongqing Cancer Hospital | Chongqing , China, 400030Fujian Provincial Cancer Hospital | Fuzhou , China, 350014Sun yat-sen University Cancer Center | Guangzhou , China, 510060Guangxi Cancer Hospital of Guangxi Medical University | Nanning , China, 530021Fudan University Shanghai Cancer Center | Shanghai , China, 200032The First Affiliated Hospital of China Medical University | Shenyang , China, 110001The First Affiliated Hospital of Wenzhou Medical University | Wenzhou , China, 325035The First Affiliated Hospital of Zhengzhou University | Zhengzhou , China, 450003Henan Cancer Hospital | Zhengzhou , China, 450008Hopital Claude Huriez | Lille , France, 59037Hopital Saint Eloi | Montpellier , France, 34295CHU NANTES - Hôtel Dieu | Nantes , France, 44093INSTITUT CURIE_SITE PARIS - Service d'Oncologie Médicale. | Paris , France, 75005Hopital Necker | Paris , France, 75743Policlinico S.Orsola-Malpighi | Bologna Emilia-Romagna, Italy, 40138Humanitas Gavazzeni | Bergamo Lombardy, Italy, 24121Irccs Istituto Europeo Di Oncologia (IEO) | Milan Lombardy, Italy, 20141SC Ematologia, AO SS. Antonio e Biagio e C. Arrigo | Alessandria Piedmont, Italy, 15121A.O. Città della Salute e della Scienza D - Osp. S. Giov. Battista Molinette | Turin Piedmont, Italy, 10126Auxilio Mutuo Cancer Center | San Juan , Puerto Rico, 00918Chungnam National University Hospital | Daejeon , South Korea, 35015Severance Hospital, Yonsei University Health System | Seoul , South Korea, 003-722Seoul National University Hospital | Seoul , South Korea, 03080Asan Medical Center | Seoul , South Korea, 05505Samsung Medical Center | Seoul , South Korea, 135-710Hospital Universitario Puerta del Mar | Cadiz Cadiz, Spain, 11009Complejo Hospitalario Universitario A Coruña (CHUAC) | A Coruña , Spain, 15006Hospital Universitari Vall d'Hebron | Barcelona , Spain, 08035Hospital Clinic de Barcelona | Barcelona , Spain, 08036Hospital General Universitario J.M Morales Meseguer | Murcia , Spain, 30008Skånes University Hospital, Skånes Department of Onclology | Lund , Sweden, 221 85Akademiska sjukhuset, Onkologkliniken | Uppsala , Sweden, 751 85National Taiwan Universtiy Hospital | Taipei , Taiwan, 100Chang Gung Medical Foundation - Linkou | Taoyuan , Taiwan, 333NHS Greater Glasgow and Clyde | Glasgow , United Kingdom, G12 0YNLincolnshire County Hospital | Lincoln , United Kingdom, LN2 5QYUniversity College London Hospital | London , United Kingdom, NW1 2PGChristie Hospital Nhs Trust | Manchester , United Kingdom, M2O 4BXOxford Churchill Hospital | Oxford , United Kingdom, OX3 7LEDerriford Hospital | Plymouth , United Kingdom, PL6 8DH
Investigators
Study Director: Clinical Trials, Hoffmann-La Roche