NCT06803693

Efficacy and Safety of Pola-RCHP-X vs Pola-RCHP in Untreated DLBCL

A Study to Evaluate the Efficacy and Safety of Genotype-guided Targeted Agents in Combination With POLA-RCHP VERSUS POLA-RCHP in Patients With Previously Untreated Diffuse Large B-cell Lymphoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy and safety of genotype-guided targeted agents in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola RCHP-X) versus Pola RCHP in Chinese patients with previously untreated diffuse large B-cell lymphoma (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	Prednisone	Prednisone PO will be administered as per the schedule specified in the respective arm.
DRUG	Zanubrutinib	Zanubrutinib PO 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.
DRUG	Decitabine	Decitabine IV infusion will be administered as per the schedule specified in the respective arm.

Timeline

• Start date: 2025-04-01
• Primary completion: 2028-04-30
• Completion: 2028-12-31
• First posted: 2025-01-31
• Last updated: 2025-12-08

Locations

1 site across 1 country: China