This study aims to compare the efficacy and safety of Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone combined with Orelabrutinib/Chidamide/Venetoclax/Lenalidomide/PD1 (Pola-RCHP-X) versus RCHOP-X and Pola-RCHP in previously untreated patients with DLBCL.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
528
Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.
Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
Progression Free Survival at 24 months (PFS24) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Time frame: At 24 months
Complete Response Rate (CRR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Time frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 8 [Cycle length=21 days]
Overall Response Rate (ORR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Time frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 8 [Cycle length=21 days]
Event Free Survival (EFS) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Time frame: up to approximately 48 months
Overall Survival (OS)
Time frame: up to approximately 48 months
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From enrollment to study completion, a maximum of 48 months
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Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
Prednisone PO will be administered as per the schedule specified in the respective arm.
Orelabrutinib PO will be administered as per the schedule specified in the respective arm.
Venetoclax PO will be administered as per the schedule specified in the respective arm.
Chidamide PO will be administered as per the schedule specified in the respective arm.
Penpulimab IV infusion will be administered as per the schedule specified in the respective arm.
Lenalidomide PO will be administered as per the schedule specified in the respective arm.