NCT07499271

Genetic Subtype-matched Targeted Therapy for the Treatment of Newly Diagnosed DLBCL With TP53 Mutation

A Prospective, Exploratory Clinical Study of Genetic Subtype-matched Precision Targeted Therapy in Newly Diagnosed DLBCL With TP53 Mutation

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of Genetic subtype-matched targeted therapy in the treatment of treatment-naive diffuse large B-cell lymphoma with TP53 mutation.

Detailed description

Using Genetic subtype-matched targeted therapy as first-line treatment for patients with treatment-naive diffuse large B-cell lymphoma (DLBCL) harboring TP53 mutations. The specific Genetic subtype-matched targeted therapy regimen is as follows: For patients with the MCD/BN2 subtype: Pola-R-CHP + orelabrutinib; For patients with other subtypes: Pola-R-CHP

Conditions

• Diffuse Large B-Cell Lymphoma (DLBCL)

Interventions

Type	Name	Description
DRUG	POLA-R-CHP	Induction treatment period (6 cycles, 21 days/cycle): Polatuzumab vedotin: 1.8 mg/kg, intravenous drip, Day 1 of each cycle Rituximab: 375 mg/m2, intravenous drip, Day 1 of each cycle CHP/CDP Regimen Cyclophosphamide: 750 mg/m² , intravenous drip, Day 2 of each cycle Doxorubicin: 50 mg/m² , intravenous drip, Day 2 of each cycle or Doxorubicin Hydrochloride Liposome: 25 mg/m² , intravenous drip, Day 2 of each cycle Prednisone: 100 mg, Days 2-6 of each cycle. Consolidation treatment period (2 cycles, 21 days/cycle): Rituximab: 375 mg/m2, intravenous drip, Day 1 of each cycle
DRUG	Orelabrutinib	Induction treatment period (6 cycles, 21 days/cycle)+Consolidation treatment period (2 cycles, 21 days/cycle). Orelabrutinib: 150mg orally per day from Days 1 to 21 of cycles 2-6 (MCD/BN2)

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2026-03-30
• Last updated: 2026-03-30

Locations

1 site across 1 country: China