A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Progression-free survival (PFS) — From randomization to the first occurrence of disease progression or death from any cause (up to approximately 24 months)
Trial sites (83)
| Facility | City | Region | Status |
|---|---|---|---|
| Alta Bates Summit Medical Center | Berkeley | California | Withdrawn |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| Indiana University | Indianapolis | Indiana | Withdrawn |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 |
| Swedish Cancer Institute | Seattle | Washington | 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 | Withdrawn |
| 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 |
+ 43 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 Spain
Other trials for the same condition
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 Spain