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

JRCT ID: jRCT2051230190

Registered date:27/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: previously untreated CD20-positive large B-cell lymphoma (LBCL)
• Date of first enrollment: 12/04/2024
• Target sample size: 1130
• Countries of recruitment: Argentina,Japan,Australia,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,China,Japan,Denmark,Japan,France,Japan,Germany,Japan,Italy,Japan,Korea,Japan,Mexico,Japan,Poland,Japan,Spain,Japan,Switzerland,Japan,Taiwan,Japan,Turkey,Japan,UK,Japan,USA,Japan
• Study type: Interventional

Intervention(s)

RO7082859: Participants will receive intravenous (IV) glofitamab
Polatuzumab Vedotin: Participants will receive IV polatuzumab vedotin in combination with R-CHP
rituximab: Participants will receive IV rituximab
Cyclophosphamide Hydrate: Participants will receive cyclophosphamide as part of CHP chemotherapy
Doxorubicin Hydrochloride: Participants will receive IV doxorubicin
Prednisolone:Participants will receive oral prednisone as part of CHP chemotherapy
Methylprednisolone Sodium Succinate: Participants will receive IV Methylprednisolone Sodium Succinate

Outcome(s)

Primary Outcome

efficacy
Lugano 2014 Response Criteria

Secondary Outcome

safety, efficacy, confirmatory, exploratory, phamacokinetics, phamacodynamics, phamacogenomics, other
Lugano 2014 Response Criteria, NCI CTCAE v5.0, ASTCT Grading system

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 80age old
• Gender: Both

Include 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

Exclude 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
-Primary or secondary CNS lymphoma at the time of recruitment or history of CNS lymphoma
-Prior radiotherapy to the mediastinal/pericardial region
-Prior therapy for LBCL, with the exception of corticosteriods
-Significant or extensive history of cardiovascular disease
-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

Related Information

• Primary Sponsor: Aurelien Berthier
• Secondary ID(s): NCT06047080