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A Study Comparing the Efficacy and Safety of Pola-RCHP-X Versus RCHOP-X and Pola-RCHP in Previously Untreated Patients With DLBCL
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Summary
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.
Official title: A Prospective, Open-Label, Multicenter, Randomized Controlled Study Comparing 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 Diffuse Large B-Cell Lymphoma
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
528
Start Date
2024-10-01
Completion Date
2029-04-01
Last Updated
2024-07-24
Healthy Volunteers
No
Conditions
Interventions
Polatuzumab vedotin
Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.
Rituximab
Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
Cyclophosphamide
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
Doxorubicin
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
Vincristine
Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
Prednisone
Prednisone PO will be administered as per the schedule specified in the respective arm.
Orelabrutinib
Orelabrutinib PO will be administered as per the schedule specified in the respective arm.
Venetoclax
Venetoclax PO will be administered as per the schedule specified in the respective arm.
Chidamide
Chidamide PO will be administered as per the schedule specified in the respective arm.
Penpulimab
Penpulimab IV infusion will be administered as per the schedule specified in the respective arm.
Lenalidomide
Lenalidomide PO will be administered as per the schedule specified in the respective arm.