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
- Conditions
- Mantle Cell Lymphoma (MCL)MedDRA version: 21.1Level: PTClassification code: 10026801Term: Mantle cell lymphoma refractory Class: 100000004864MedDRA version: 21.0Level: PTClassification code: 10026800Term: Mantle cell lymphoma recurrent Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]Therapeutic area: Health Care [N] - Environment and Public Health [N06]
- Registration Number
- CTIS2023-503206-37-00
- Lead Sponsor
- F. Hoffmann-La Roche AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 176
Life expectancy >= 12 weeks, Histologically-confirmed MCL, with documentation of either overexpression of cyclin D1 or the presence of t(11:14), Relapsed or refractory disease, At least one (>= 1) line of prior systemic therapy that must include a BTK inhibitor, Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2, Adequate hematologic function
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, 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, Known or suspected chronic active Epstein Barr viral infection, history of hemophagocytic lymphohistiocytosis (HLH) and progressive multifocal leukoencephalopathy (PML), Clinically significant history of cirrhotic liver disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method