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A Study to Compare the Efficacy and Safety of Glofitamab as a Single Agent Versus Investigator’s Choice in Patients with Relapsed/Refractory Mantle Cell Lymphoma
EU CTIS ID: 2023-503206-37-00
What this study is testing
To evaluate the efficacy of glofitamab monotherapy compared with an investigator’s choice of bendamustine with rituximab (BR) or lenalidomide with rituximab (R-Len) with respect to progression-free survival (PFS)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- PET-positive disease at screening (Deauville score of 4 or 5) according to the “Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification” with at least one target FDG-avid lesion In rare cases of non-FDG-avid MCL with at least one measurable lesion located in an area suitable for biopsy, such as the gastrointestinal tract and a biopsy can be obtained to confirm a histological diagnosis, a participant may be eligible
- Histologically-confirmed MCL, demonstrating either overexpression of cyclin D1 or the presence of t(11:14) within 12 months of study entry
- Relapsed or refractory disease
- At least one (>= 1) line of prior systemic therapy: - Inclusion of BTK inhibitor Prior therapy must have included a BTK inhibitor plus another systemic therapy option (e.g., a regimen containing a CD20 monoclonal antibody, prior chemotherapy, targeted agent therapy such as bortezomib, etc.) – Progression or Relapse: Participants must have progressed or relapsed at any time on BTK inhibitor therapy, or failed to achieve a partial response (PR) within 12 weeks of BTK inhibitor therapy – Exclusion of BTK Inhibitor Intolerance: Participants intolerant to BTK inhibitor therapy who are unable to complete at least 12 weeks of BTK inhibitor therapy should be excluded – Local Therapies: Local therapies (e.g., radiotherapy) will not be considered as lines of therapy
- Adequate renal function, defined as an estimated creatinine clearance ≥ 30 mL/min
- Adequate hematologic function
You likely can't join if
- History of other malignancy that could affect compliance with the protocol or interpretation of results - Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the compliance of or safety or efficacy assessment of the investigational regimen are eligible for this study
- Leukemic, non-nodal MCL
- Prior solid organ transplantation, prior allogeneic stem cell transplant
- Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3 and also treatment with chimeric antigen receptor T-cell (CAR-T) cell therapy
- Primary or secondary central nervous system (CNS) lymphoma at the time of recruitment or history of CNS lymphoma
- Presence of severe active bacterial, viral, fungal, mycobacterial, parasitic, or other infections at the time of study enrolment. Participants must have recovered from any severe or potentially serious infection (as assessed by the investigator) at least 2 weeks before the first study treatment
See the full eligibility criteria
Who can join
- PET-positive disease at screening (Deauville score of 4 or 5) according to the “Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification” with at least one target FDG-avid lesion In rare cases of non-FDG-avid MCL with at least one measurable lesion located in an area suitable for biopsy, such as the gastrointestinal tract and a biopsy can be obtained to confirm a histological diagnosis, a participant may be eligible
- Histologically-confirmed MCL, demonstrating either overexpression of cyclin D1 or the presence of t(11:14) within 12 months of study entry
- Relapsed or refractory disease
- At least one (>= 1) line of prior systemic therapy: - Inclusion of BTK inhibitor Prior therapy must have included a BTK inhibitor plus another systemic therapy option (e.g., a regimen containing a CD20 monoclonal antibody, prior chemotherapy, targeted agent therapy such as bortezomib, etc.) – Progression or Relapse: Participants must have progressed or relapsed at any time on BTK inhibitor therapy, or failed to achieve a partial response (PR) within 12 weeks of BTK inhibitor therapy – Exclusion of BTK Inhibitor Intolerance: Participants intolerant to BTK inhibitor therapy who are unable to complete at least 12 weeks of BTK inhibitor therapy should be excluded – Local Therapies: Local therapies (e.g., radiotherapy) will not be considered as lines of therapy
- Adequate renal function, defined as an estimated creatinine clearance ≥ 30 mL/min
- Adequate hematologic function
What rules you out
- History of other malignancy that could affect compliance with the protocol or interpretation of results - Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the compliance of or safety or efficacy assessment of the investigational regimen are eligible for this study
- Leukemic, non-nodal MCL
- Prior solid organ transplantation, prior allogeneic stem cell transplant
- Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3 and also treatment with chimeric antigen receptor T-cell (CAR-T) cell therapy
- Primary or secondary central nervous system (CNS) lymphoma at the time of recruitment or history of CNS lymphoma
- Presence of severe active bacterial, viral, fungal, mycobacterial, parasitic, or other infections at the time of study enrolment. Participants must have recovered from any severe or potentially serious infection (as assessed by the investigator) at least 2 weeks before the first study treatment
- Clinically significant history of cirrhotic liver disease
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Brazil
- China
- Taiwan
- United States
- Australia
- Korea, Republic of
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Brazil; China; Taiwan; United States; Australia and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.