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NOT YET RECRUITING
NCT06516978
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Polatuzumab vedotin

Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

Rituximab

Rituximab IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

Cyclophosphamide

Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

Doxorubicin

Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

Vincristine

Vincristine IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

Prednisone

Prednisone PO will be administered as per the schedule specified in the respective arm.

DRUG

Orelabrutinib

Orelabrutinib PO will be administered as per the schedule specified in the respective arm.

DRUG

Venetoclax

Venetoclax PO will be administered as per the schedule specified in the respective arm.

DRUG

Chidamide

Chidamide PO will be administered as per the schedule specified in the respective arm.

DRUG

Penpulimab

Penpulimab IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

Lenalidomide

Lenalidomide PO will be administered as per the schedule specified in the respective arm.