Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT07499271

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

Led by The First Affiliated Hospital of Soochow University · Updated on 2026-03-30

35

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 to 70 years
  • Able to understand and sign informed consent
  • Eastern Cooperative Oncology Group performance status between 0 and 3
  • Life expectancy of at least 3 months
  • Newly diagnosed, untreated CD20-positive diffuse large B-cell lymphoma confirmed by pathology
  • Measurable disease with PET-CT showing tumor size at least 1.5 cm in short-axis diameter
  • Adequate bone marrow, liver, coagulation, and kidney function without recent blood transfusion or medication correction
  • Females of childbearing potential must agree to use effective contraception during treatment and for 5 weeks after last dose
  • Sexually active males must agree to use effective contraception during treatment and for 3 months after last dose
  • No difficulty swallowing oral tablets or capsules
  • Good compliance and willingness to follow visit schedules, dosing, laboratory tests, and examinations
Not Eligible

You will not qualify if you...

  • Previous systemic anti-tumor therapy
  • Central nervous system involvement
  • Recent or ongoing use of systemic adrenal corticosteroids above specified doses
  • Active other cancers requiring treatment
  • Uncontrolled or severe heart disease or arrhythmias
  • Uncontrolled infection or infection needing intravenous antibiotics
  • Active hepatitis B or C infection or syphilis; HIV infection
  • Significant gastrointestinal problems affecting drug absorption
  • History of bleeding disorders or need for long-term oral anticoagulation
  • Pregnancy or breastfeeding
  • Allergy to study drugs or ingredients
  • Active psychiatric disorders, alcohol or drug dependence, or substance abuse
  • Life-threatening diseases or conditions affecting safety or study compliance
  • Other investigator-determined conditions making participation unsuitable

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China, 215006

Actively Recruiting

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Research Team

C

Changju Qu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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