drugset / Trial / NCT06803693

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

NCT06803693

Phase 2 Recruiting 152 enrolled Ruijin Hospital
RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2025-04-01
Primary completion
2028-04-30
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Decitabine Small molecule 10 mg/m2 Intravenous
Subject Lenalidomide Other / unclassified 25 mg Oral
Subject Zanubrutinib Small molecule 160 mg Oral
Background Cyclophosphamide Other / unclassified 750 mg/m2 Intravenous
Background Doxorubicin Other / unclassified 50 mg/m2 Intravenous
Background Polatuzumab Vedotin Other / unclassified 1.8 mg/kg Intravenous
Background Prednisone Other / unclassified 100 mg Oral
Background Rituximab Monoclonal antibody 375 mg/m2 Intravenous