RecruitingPhase 2

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

China35 participantsStarted 2026-01-01

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. 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):
✓. 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.

Exclusion criteria

✕. Patients who have previously received systemic anti-tumor therapy.
✕. Patients with central nervous system involvement.
✕. Patients who received systemic adrenal corticosteroids for more than 5 days within 14 days prior to study drug administration, or who require daily doses of \>10 mg of dexamethasone or equivalent drugs to control central nervous system disease.
✕. Active concurrent malignancy requiring active treatment.
✕. Uncontrolled or severe cardiovascular disease, including (but not limited to) any of the following: congestive heart failure (NYHA class III or IV); myocardial infarction; unstable angina; or presence of arrhythmia requiring treatment at screening, with left ventricular ejection fraction (LVEF) \< 50% within 6 months prior to the first dose; primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, undefined cardiomyopathy); clinically significant history of QTc prolongation, second-degree type II atrioventricular block or third-degree atrioventricular block, or QTc interval (Fridericia's method) \> 470 ms (female) or \> 480 ms (male); atrial fibrillation; patients with uncontrolled hypertension considered unsuitable for participation in the study.
✕. Uncontrolled infection or infection requiring intravenous antibiotic therapy.
✕. Chronic hepatitis B carriers with active hepatitis B or hepatitis C infection (hepatitis B: acute hepatitis B, untreated chronic hepatitis B virus infection, HBV-DNA ≥ the detection limit of the respective center; hepatitis C: HCV RNA positive) or syphilis. Note: Inactive hepatitis B surface antigen (HBsAg) carriers, subjects with active HBV infection and sustained HBV suppression (HBV DNA \< detection limit of the respective center), and subjects cured of HCV may be enrolled.
✕. Clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (such as active gastrointestinal inflammation, chronic diarrhea, intestinal obstruction, etc.), or patients with total gastrectomy, gastric banding surgery, or tumor involvement of the gastrointestinal tract.

What they're measuring

2-year progression-free survival(PFS)

Timeframe: From date of signing the informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

Trial details

NCT IDNCT07499271

SponsorThe First Affiliated Hospital of Soochow University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Changju Qu

67781865 qcj310@163.com

View on ClinicalTrials.gov More Diffuse Large B-Cell Lymphoma (DLBCL) trials