An Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma

Phase 3

• Conditions: previously untreated CD20-positive large B-cell lymphoma (LBCL)

• Registration Number: JPRN-jRCT2051230190
• Lead Sponsor: Aurelien Berthier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-27
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 1130

Inclusion Criteria

Previously untreated participants with CD20-positive LBCL
-Ability to provide tumor tissue
-International prognostic index (IPI) score 2-5
-Eastern cooperative oncology group (ECOG) performance status of 0, 1, or 2
-At least one bi-dimensionally measurable lesion, defined as > 1.5 cm in its longest dimension as measured by CT or MRI
-Left ventricular ejection fraction (LVEF) >=50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)
-Adequate hematologic function
-Negative HIV test at screening with exceptions as defined by the protocol
-Negative SARS-CoV-2 antigen or PCR test

Exclusion Criteria

-Contraindication to any of the individual components of Pola-R-CHP or glofitamab
-Prior solid organ transplantation
-History of indolent lymphoma
-Current diagnosis of the following: Follicular lymphoma grade 3B; transformations of indolent B-cell lymphomas (e.g., de novo transformed follicular lymphoma); mediastinal grey zone lymphoma; primary mediastinal (thymic) large B-cell lymphoma; Burkitt lymphoma; primary large B-cell lymphoma of immune-privileged sites (encompassing primary diffuse large B-cell lymphoma of the CNS, primary large B-cell lymphoma of the vitreoretina and primary large B-cell lymphoma of the testis); primary effusion DLBCL; and primary cutaneous DLBCL, leg type
-Prior radiotherapy to the mediastinal/pericardial region
-Prior therapy for LBCL, with the exception of corticosteriods
-Significant or extensive history of cardiovascular disease
-History of treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents
-Active autoimmune disease which is not well controlled by therapy
-History of progressive multifocal leukoencephalopathy
-Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
-Clinically significant liver disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified