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

NCT07499271 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-03-30

No results posted yet for this study

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.

Conditions

  • Diffuse Large B-Cell Lymphoma (DLBCL)

Interventions

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)

Sponsors & Collaborators

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07499271 on ClinicalTrials.gov