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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06084936
Other study ID # GO43878
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date October 22, 2023
Est. completion date December 31, 2026

Study information

Verified date June 2024
Source Hoffmann-La Roche
Contact Reference Study ID Number: GO43878 https://forpatients.roche.com
Phone 888-662-6728
Email global-roche-genentech-trials@gene.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 182
Est. completion date December 31, 2026
Est. primary completion date February 2, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Obinutuzumab
Participants will receive two 1000 mg pretreatments of intravenous (IV) obinutuzumab from Cycle 1 Day 1
Glofitamab
Participants will receive IV glofitamab beginning Cycle 1 Day 8 for 12 cycles (cycle length = 21 days).
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).
Bendamustine
Participants will receive IV bendamustine on Days 1 and 2 Q4W for 6 cycles (cycle length = 28 days).
Lenalidomide
Participants will receive oral lenalidomide once daily on Days 1-21 Q4W until disease progression.
Tocilizumab
Participants will receive IV tocilizumab as required to manage cytokine release syndrome (CRS) events.

Locations

Country Name City State
Australia Royal Adelaide Hospital; Haematology Clinical Trials Adelaide South Australia
Australia Epworth Hospital Richmond Victoria
Australia Calvary Mater Newcastle; Medical Oncology Waratah New South Wales
Brazil ICTR Curitiba Curitiba PR
Brazil Hospital Mae de Deus Porto Alegre RS
Brazil Americas Medical City Rio de Janeiro RJ
Brazil Hospital A. C. Camargo; Oncologia Sao Paulo SP
Brazil Hospital Alemao Oswaldo Cruz Sao Paulo SP
Brazil Hospital Paulistano Sao Paulo SP
Brazil Instituto D'Or Pesquisa e Ensino Sao Paulo SP
Brazil Beneficencia Portuguesa de Sao Paulo São Paulo SP
Canada Victoria Hospital - London Health Sciences Centre London Ontario
Canada The Ottawa Hospital - General Campus Ottawa Ontario
China Beijing Tong Ren Hospital, Capital Medical University Beijing
China The First Hospital of Jilin University Changchun City
China West China Hospital of Sichuan University Chengdu City
China Chongqing Cancer Hospital Chongqing
China Fujian Provincial Cancer Hospital Fuzhou City
China Sun yat-sen University Cancer Center; Internal Medicine of Oncology Guangzhou
China Guangxi Cancer Hospital of Guangxi Medical University Nanning City
China Fudan University Shanghai Cancer Center; Medical Oncology Shanghai City
China The First Affiliated Hospital of China Medical University Shenyang City
China The First Affiliated Hospital of Wenzhou Medical University Wenzhou City
China The First Affiliated Hospital of Zhengzhou University; Branch Hospital in NEW ZHENGDONG District Zhengzhou
China Henan Cancer Hospital; Hematology department Zhengzhou City
France Hopital Claude Huriez; Hematologie Lille
France Hopital Saint Eloi; Hematologie Oncologie Medicale Montpellier
France CHU NANTES - Hôtel Dieu; Service d'Hematologie Clinique Nantes
France INSTITUT CURIE_SITE PARIS - Service d'Oncologie Médicale. St Cloud
Italy SC Ematologia, AO SS. Antonio e Biagio e C. Arrigo Alessandria Piemonte
Italy Humanitas Gavazzeni;U.O. Oncologia Medica Bergamo Lombardia
Italy Irccs Istituto Europeo Di Oncologia (IEO); Emato-Oncologia Milano Lombardia
Italy A.O. Città della Salute e della Scienza D - Osp. S. Giov. Battista Molinette; Ematologia I Torino Piemonte
Korea, Republic of Chungnam National University Hospital Daejeon
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
Spain Hospital Clinic de Barcelona Barcelona
Spain Hospital Universitari Vall d'Hebron; Servicio de Hematologia Barcelona
Spain Hospital Universitario Puerta del Mar; Servicio de Hematologia Cádiz Cadiz
Spain Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Hematologia La Coruna LA Coruña
Spain Hospital General Universitario J.M Morales Meseguer; Servicio de Hematología Murcia
Sweden Skånes University Hospital, Skånes Department of Onclology Lund
Sweden Akademiska sjukhuset, Onkologkliniken Uppsala
Taiwan National Taiwan Universtiy Hospital; Division of Hematology Taipei
Taiwan Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology Taoyuan
United Kingdom Oxford Churchill Hospital; Cancer and Haematology Centre,Level 2 Oxford
United Kingdom Derriford Hospital; Haematology Plymouth
United States St. Luke's Hospital Chesterfield Missouri
United States City of Hope Cancer Center Duarte California
United States Avera Cancer Institute Sioux Falls South Dakota

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  China,  France,  Italy,  Korea, Republic of,  Spain,  Sweden,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free survival (PFS) From randomization to the first occurrence of disease progression or death from any cause (up to approximately 24 months)
Secondary Complete response (CR) rate Up to approximately 24 months
Secondary Objective response rate (ORR) Up to approximately 24 months
Secondary Overall survival (OS) From randomization to death from any cause (up to approximately 24 months)
Secondary Time to deterioration in physical functioning/fatigue From randomization to a 10-point decrease in physical functioning/10-point increase in fatigue compared to baseline (up to approximately 24 months)
Secondary Investigator-assessed PFS From randomization to disease progression or death from any cause (up to approximately 24 months)
Secondary Investigator-assessed CR rate Up to approximately 24 months
Secondary Investigator-assessed ORR Up to approximately 24 months
Secondary Duration of Complete Response (DOCR) From the initial occurrence of a documented CR until documented disease progression or death due to any cause, whichever occurs first (up to approximately 24 months)
Secondary Duration of Response (DOR) From the initial occurrence of a documented CR until documented disease progression or death due to any cause, whichever occurs first (up to approximately 24 months)
Secondary Proportion of participants reporting each response option for item GP5 from the Functional Assessment of Cancer Therapy - General (FACT-G) subscale Up to approximately 24 months
Secondary Time to deterioration in lymphoma symptoms From randomization to the first documentation of a 3-point or more decrease in score as assessed by the FACT-Lym lymphoma subscale (LymS) questionnaire (up to approximately 24 months)
Secondary 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 Up to approximately 24 months
Secondary 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." Up to approximately 24 months
Secondary Change from baseline in lymphoma symptoms at each cycle as assessed by the FACT-Lym LymS Up to approximately 24 months
Secondary Serum concentration of glofitamab Up to approximately 24 months
Secondary Incidence of anti-drug antibodies (ADAs) Up to approximately 24 months
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