Actively Recruiting
A Prospective, Exploratory Clinical Study of Genetic Subtype-matched Precision Targeted Therapy in 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of genetic subtype-matched targeted therapy as a first-line treatment for patients newly diagnosed with diffuse large B-cell lymphoma (DLBCL) that has a TP53 mutation. This phase 2 study aims to assess how well these targeted therapies work and their safety in this specific group of patients. The study focuses on treatment-naive individuals, meaning those who have not yet received systemic anti-tumor therapy, to better understand the impact of the therapies on this serious lymphoma subtype. The treatment involves two different regimens based on the genetic subtype of the lymphoma. Patients with the MCD/BN2 subtype will receive Pola-R-CHP combined with orelabrutinib during the induction period of six 21-day cycles, followed by two consolidation cycles of rituximab plus orelabrutinib. Patients with other subtypes will receive Pola-R-CHP alone for the induction period and rituximab alone during consolidation. Pola-R-CHP includes polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin or its liposomal form, and prednisone, administered according to a set schedule. Participants will be involved in treatment cycles lasting 21 days each, with evaluations after six cycles and during consolidation. Researchers will assess progression-free survival over two years, complete response rates at the end of induction, and overall survival after two years. Assessments include PET-CT scans to measure disease, laboratory tests to monitor organ function, and performance status evaluations. Safety and adherence to treatment schedules will be closely monitored throughout the study, which enrolls adults aged 18 to 70 years.
CONDITIONS
Brief Title
Genetic Subtype-matched Targeted Therapy for the Treatment of Newly Diagnosed DLBCL With TP53 Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years and older, up to 70 years.
- Able to understand and willing to sign written informed consent.
- Eastern Cooperative Oncology Group performance status 0 to 3.
- Life expectancy of at least 3 months.
- Newly diagnosed, treatment-naive CD20-positive diffuse large B-cell lymphoma confirmed by pathology.
- Measurable disease with PET-CT showing tumor diameter of at least 1.5 cm.
- Adequate bone marrow function: neutrophils ≥1.5×10⁹/L, platelets ≥80×10⁹/L, hemoglobin ≥80 g/L without recent transfusion or medication correction.
- Adequate liver function: bilirubin ≤1.5× upper limit of normal (ULN), or ≤3.0× ULN if liver metastases present; AST and ALT ≤2.5× ULN, or ≤5.0× ULN if liver metastases present.
- Coagulation function within normal limits (INR and aPTT ≤1.5× ULN).
- Adequate renal function: serum creatinine ≤1.5× ULN or creatinine clearance ≥60 mL/min.
- Females of childbearing potential must use effective contraception during treatment and 5 weeks after last dose; sexually active males must use contraception during treatment and for 3 months after last dose.
- No difficulty swallowing oral tablets or capsules.
- Good compliance and willingness to follow visit, dosing, laboratory, and examination schedules.
You will not qualify if you...
- Prior systemic anti-tumor therapy.
- Central nervous system involvement.
- Recent use of systemic adrenal corticosteroids for more than 5 days within 14 days before treatment or need for daily high-dose corticosteroids.
- Active other malignancies requiring treatment.
- Uncontrolled or severe heart disease including heart failure, recent heart attack, unstable angina, significant arrhythmias, or poor heart function.
- Uncontrolled infections or infections needing intravenous antibiotics.
- Active hepatitis B or C infection or syphilis; HIV infection.
- Significant gastrointestinal problems affecting drug absorption or intake.
- History of bleeding disorders or need for long-term blood thinners.
- Pregnant or breastfeeding women.
- Allergy to study drugs or their ingredients.
- Active psychiatric disorders or substance abuse.
- Life-threatening diseases or conditions affecting safety or compliance.
- Other conditions deemed unsuitable by the investigator for participation.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 8 months (8 cycles of 21 days each)
Participants receive genetic subtype-matched targeted therapy as first-line treatment for newly diagnosed diffuse large B-cell lymphoma with TP53 mutation. This includes an induction period of 6 cycles (21 days per cycle) of Pola-R-CHP, with orelabrutinib added for certain subtypes, followed by a consolidation period of 2 cycles (21 days per cycle) of rituximab with or without orelabrutinib depending on subtype.
8 cycles with visits on Day 1 and Day 2 of each cycle plus daily oral dosing Days 1 to 21 during cycles 2-6 for certain participants
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
Research Team
C
Changju Qu
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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