A Study to Comparing the Efficacy and Safety of Glofitamab (RO7082859) in Combination with Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (Pola-R-CHP) Versus Pola-R-CHP in Previously Untreated Patients with Large B-Cell Lymphoma
- Conditions
- arge B-Cell LymphomaMedDRA version: 20.1Level: LLTClassification code: 10080211Term: T-cell/histiocyte-rich large B-cell lymphoma Class: 10029104MedDRA version: 20.1Level: LLTClassification code: 10080218Term: High-grade B-cell lymphoma NOS Class: 10029104MedDRA version: 21.0Level: PTClassification code: 10012818Term: Diffuse large B-cell lymphoma Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-504028-24-00
- Lead Sponsor
- F. Hoffmann-La Roche AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1130
Previously untreated participants with cluster of differentiation 20 (CD20)- positive large B-cell lymphoma (LBCL), including diagnoses by 2022 world health organization (WHO) classification of lymphoid neoplasms, Ability to provide tumor tissue; archival or freshly collected, IPI score 2-5, Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2, Life expectancy >= 6 months, Adequate hematologic function, Negative human immunodeficiency virus (HIV) test at screening
Contraindication to any of the individual components of Pola-R-CHP or glofitamab, including prior receipt of anthracyclines, or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, or known sensitivity or allergy to murine products, Prior solid organ transplantation, History of indolent lymphoma, Active autoimmune disease which is not well controlled by therapy, Positive test results for chronic hepatitis B infection, hepatitis C (hepatitis C virus [HCV] antibody serology testing) and human T lymphotropic virus type 1 (HTLV-1), Participants with a history of progressive multifocal leukoencephalopathy
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