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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

Genetic Subtype-matched Targeted Therapy for the Treatment of Newly Diagnosed DLBCL With TP53 Mutation (NCT07499271) is a Phase 2 interventional studying Diffuse Large B-Cell Lymphoma (DLBCL), sponsored by The First Affiliated Hospital of Soochow University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Diffuse Large B-Cell Lymphoma (DLBCL) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 35 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Patients aged 18 years and older, up to 70 years. 2. Participants must be able to understand and willing to sign the written willing to sign a consent form form. 3. Eastern Cooperative Oncology Group performance status 0 to 3. 4. Life expectancy ≥3 months (as determined by the investigator). 5. Pathologically (histologically or cytologically) confirmed treatment-naive CD20-positive diffuse large B-cell lymphoma. 6. Measurable disease defined by PET-CT as a short-axis diameter of at least ≥1.5 cm. 7. 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, blood count (hemoglobin) at least 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 kidney function (creatinine clearance) at least 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) / \[85 × serum creatinine concentration (mg/dL)\]). 8. 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. 9. No difficulty swallowing oral tablets/capsules. 10. Good compliance and willingness to adhere to visit schedules, dosing schedules, laboratory tests, and other examination procedures. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Patients aged 18 years and older, up to 70 years. 2. Participants must be able to understand and willing to sign the written informed consent form. 3. Eastern Cooperative Oncology Group performance status 0 to 3. 4. Life expectancy ≥3 months (as determined by the investigator). 5. Pathologically (histologically or cytologically) confirmed treatment-naive CD20-positive diffuse large B-cell lymphoma. 6. Measurable disease defined by PET-CT as a short-axis diameter of at least ≥1.5 cm. 7. 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) / \[85 × serum creatinine concentration (mg/dL)\]). 8. 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. 9. No difficulty swallowing oral tablets/capsules. 10. Good compliance and willingness to adhere to visit schedules, dosing schedules, laboratory tests, and other examination procedures. Exclusion Criteria: 1. Patients who have previously received systemic anti-tumor therapy. 2. Patients with central nervous system involvement. 3. 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. 4. Active concurrent malignancy requiring active treatment. 5. 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. 6. Uncontrolled infection or infection requiring intravenous antibiotic therapy. 7. 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. Human immunodeficiency virus (HIV) infection. 8. 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. 9. Patients with a history of bleeding disorders, or patients requiring long-term oral anticoagulation due to comorbidities. 10. Female subjects who are currently pregnant or breastfeeding. 11. Allergy to the study drug or excipients. 12. Patients with active psychiatric disorders, alcohol dependence, drug dependence, or substance abuse. 13. Presence of any life-threatening disease, medical condition, or organ system dysfunction that, in the investigator's opinion, may affect patient safety or compliance with study procedures. 14. Other conditions that, in the investigator's opinion, make the patient unsuitable for participation in this clinical trial.

Treatments Being Tested

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)

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07499271), the sponsor (The First Affiliated Hospital of Soochow University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07499271 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07499271?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07499271?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07499271. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07499271. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.