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
Key facts
- Where
- A Coruña, Barcelona, Cadiz és Murcia, SpanyolországSee the 5 sites
- Phase
- 3. fázis
Where in Spanyolország
- Complexo Hospitalario Universitario A CoruñaA Coruña, SpanyolországTaking people
- Hospital Clinic de BarcelonaBarcelona, SpanyolországTaking people
- Hospital Universitari Vall d'HebronBarcelona, SpanyolországTaking people
- Hospital Universitario Puerta del MarCadiz, SpanyolországTaking people
- Hospital General Universitario Morales MeseguerMurcia, SpanyolországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- F. Hoffmann-La Roche AG
- Trial code
- EU 2023-503206-37-00
- Record updated
- 2026. szeptember 9.
- Original description
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)Read full original descriptionShow less
A PHASE III, OPEN-LABEL, MULTICENTER RANDOMIZED STUDY EVALUATING GLOFITAMAB AS A SINGLE AGENT VERSUS INVESTIGATOR’S CHOICE IN PATIENTS WITH RELAPSED/REFRACTORY MANTLE CELL LYMPHOMA
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)
Inclusion: 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.
Exclusion: 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; 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; 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; Primary or secondary central nervous system (CNS) lymphoma at the time of recruitment or history of CNS lymphoma; Clinically significant history of cirrhotic liver disease; Leukemic, non-nodal MCL.