NCT06516978

A Study Comparing the Efficacy and Safety of Pola-RCHP-X Versus RCHOP-X and Pola-RCHP in Previously Untreated Patients With DLBCL

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 528 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diffuse Large B Cell Lymphoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-10-01
• Primary completion: 2028-10-01
• Completion: 2029-04-01
• First posted: 2024-07-24
• Last updated: 2024-07-24

Regulatory

• FDA-regulated drug study