NCT06084936 · Hoffmann-La Roche
A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma
(GLOBRYTE)
What this study is about
The purpose of this study is to evaluate the effectiveness of glofitamab treatment given alone 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).
View original scientific description
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).
Interventions
DRUG
Obinutuzumab
Participants will receive two 1000 mg pretreatments of intravenous (IV) obinutuzumab from Cycle 1 Day 1
DRUG
Glofitamab
Participants will receive IV glofitamab beginning Cycle 1 Day 8 for 12 cycles (cycle length = 21 days).
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).
DRUG
Bendamustine
Participants will receive IV bendamustine on Days 1 and 2 Q4W for 6 cycles (cycle length = 28 days).
DRUG
Lenalidomide
Participants will receive oral lenalidomide once daily on Days 1-21 Q4W until disease progression.
DRUG
Tocilizumab
Participants will receive IV tocilizumab as required to manage cytokine release syndrome (CRS) events.
Primary outcome measures
Progression-free survival (PFS)
Time frame: From randomization to the first occurrence of disease progression or death from any cause (up to approximately 24 months)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Berkeley, California
- Duarte, California
- Santa Monica, California
- New Haven, Connecticut
- Washington D.C., District of Columbia
- Coral Gables, Florida
- Indianapolis, Indiana
- Ann Arbor, Michigan
- Chesterfield, Missouri
- Reno, Nevada
- New Brunswick, New Jersey
- East Syracuse, New York
And 7 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 2, 2026 · Source of record for eligibility and locations