Diffuse Large B-Cell Lymphoma (DLBCL) Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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• Patients aged 18 years and older, up to 70 years.

• Participants must be able to understand and willing to sign the written informed consent form.

• Eastern Cooperative Oncology Group performance status 0 to 3.

• Life expectancy ≥3 months (as determined by the investigator).

• Pathologically (histologically or cytologically) confirmed treatment-naive CD20-positive diffuse large B-cell lymphoma.

• Measurable disease defined by PET-CT as a short-axis diameter of at least ≥1.5 cm.

• Bone marrow and organ function meeting the following criteria (without blood transfusion, G-CSF, or medication correction within 14 days prior to screening):

• Bone marrow function: Absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥80×10⁹/L, hemoglobin ≥80 g/L.

• Liver function: Total serum bilirubin ≤1.5×ULN (≤3.0×ULN if liver metastases present); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN (≤5.0×ULN if liver metastases present).

• Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time ≤1.5×ULN.

• Renal function: Serum creatinine ≤1.5×ULN or estimated creatinine clearance ≥60 mL/min (for males: Cr (mL/min) = (140 - age) × body weight (kg) / \[72 × serum creatinine concentration (mg/dL)\]; for females: Cr (mL/min) = (140 - age) × body weight (kg) / \[85 × serum creatinine concentration (mg/dL)\]).

• Females of childbearing potential must agree to use highly effective contraceptive methods during the treatment period and for 5 weeks after the last dose of study drug. Sexually active males must agree to use highly effective contraception during the treatment period and for 3 months after the last dose.

• No difficulty swallowing oral tablets/capsules.

⁃ Good compliance and willingness to adhere to visit schedules, dosing schedules, laboratory tests, and other examination procedures.

Locations
Other Locations
China
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Contact Information
Primary
Changju Qu
qcj310@163.com
67781865
Time Frame
Start Date: 2026-01-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 35
Treatments
Experimental: Pola-R-CHP + orelabrutinib or Pola-R-CHP
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:~Induction treatment period (6 cycles, 21 days/cycle):~For patients with the MCD/BN2 subtype: Pola-R-CHP + orelabrutinib; For patients with other subtypes: Pola-R-CHP Consolidation treatment period (2 cycles, 21 days/cycle): For patients with the MCD/BN2 subtype: R + orelabrutinib; For patients with other subtypes: R
Sponsors
Leads: The First Affiliated Hospital of Soochow University

This content was sourced from clinicaltrials.gov