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Clinical Trials in the UK / NCT06084936
Recruiting Phase 3

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

NCT06084936 · tracked via the Priya Life Science UK tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Started
2023-10-22
Last updated
2026-09-03

Condition(s) studied

Lymphoma

Investigational drug(s) / intervention(s)

ObinutuzumabGlofitamabRituximabBendamustineLenalidomideTocilizumab

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.

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (82)

FacilityCityRegionStatus
Alta Bates Summit Medical Center Berkeley California Withdrawn
City of Hope Cancer Center Duarte California Recruiting
Valkyrie Clinical Trials Los Angeles California Recruiting
University of California Los Angeles (UCLA) - Cancer Care - Santa Monica Santa Monica California Recruiting
Yale Cancer Center New Haven Connecticut Recruiting
Georgetown University Washington D.C. District of Columbia Recruiting
University of Miami Coral Gables Florida Recruiting
Moffitt Cancer Center Tampa Florida Recruiting
Indiana University Indianapolis Indiana Withdrawn
University of Iowa Iowa City Iowa Recruiting
University of Iowa Health Care Waukee Iowa Recruiting
University of Michigan Health System Ann Arbor Michigan Recruiting
St. Luke's Hospital Chesterfield Missouri Recruiting
Renown Regional Medical Center Reno Nevada Recruiting
Rutgers Cancer Institute of New Jersey New Brunswick New Jersey Recruiting
Hematology Oncology Associates of Central New York East Syracuse New York Recruiting
University of Rochester Rochester New York Recruiting
Stony Brook University Hospital Cancer Center Stony Brook New York Recruiting
Medical University of S. Carolina Charleston South Carolina Withdrawn
Avera Cancer Institute Sioux Falls South Dakota Withdrawn
Renovatio Clinical - El Paso El Paso Texas Recruiting
Renovatio Clinical The Woodlands Texas Recruiting
University of Virginia Charlottesville Virginia Recruiting
West Virginia University Morgantown West Virginia Recruiting
Calvary Mater Newcastle Waratah New South Wales Recruiting
Royal Adelaide Hospital Adelaide South Australia Recruiting
Epworth Hospital Richmond Victoria Recruiting
Hospital Sao Rafael - HSR Salvador Estado de Bahia Withdrawn
Ictrials Pesquisa e Desenvolvimento Curitiba Paraná Recruiting
Hospital Mae de Deus Porto Alegre Rio Grande do Sul Recruiting
Hospital Paulistano São Paulo São Paulo Recruiting
Hospital Alemao Oswaldo Cruz São Paulo São Paulo Recruiting
Hospital A. C. Camargo São Paulo São Paulo Recruiting
Instituto D'Or Pesquisa e Ensino São Paulo São Paulo Recruiting
Americas Medical City Rio de Janeiro Brazil Recruiting
Beneficencia Portuguesa de Sao Paulo São Paulo Brazil Recruiting
Victoria Hospital - London Health Sciences Centre London Ontario Recruiting
The Ottawa Hospital - General Campus Ottawa Ontario Recruiting
Princess Margaret Cancer Center Toronto Ontario Recruiting
Beijing Tong Ren Hospital, Capital Medical University Beijing China Recruiting

+ 42 more sites — see the full list on the official registry below.

On this site

📄 Rituxan (rituximab) drug profile → 📄 Revlimid (lenalidomide) drug profile → 📄 Actemra (tocilizumab) drug profile →

More Hoffmann-La Roche trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06084936 on ClinicalTrials.gov ↗ ← All trials in the UK