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OncoMatch/Clinical Trials/NCT07499271

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

Is NCT07499271 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including POLA-R-CHP and Orelabrutinib for diffuse large b-cell lymphoma (dlbcl).

Phase 2RecruitingThe First Affiliated Hospital of Soochow UniversityNCT07499271Data as of May 2026

Treatment: POLA-R-CHP · OrelabrutinibTo 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.

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Extracted eligibility criteria

Cancer type

Diffuse Large B-Cell Lymphoma

Non-Hodgkin Lymphoma

Biomarker criteria

Required: TP53 mutation

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

Required: MS4A1 overexpression

CD20-positive diffuse large B-cell lymphoma

Performance status

ECOG 0–3(Limited self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic anti-tumor therapy

Patients who have previously received systemic anti-tumor therapy

Cannot have received: systemic adrenal corticosteroids (dexamethasone)

Exception: ≤5 days within 14 days prior to study drug administration; daily doses ≤10 mg dexamethasone or equivalent drugs

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

Lab requirements

Blood counts

Absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥80×10⁹/L, hemoglobin ≥80 g/L

Kidney function

Serum creatinine ≤1.5×ULN or estimated creatinine clearance ≥60 mL/min

Liver function

Total serum bilirubin ≤1.5×ULN (≤3.0×ULN if liver metastases present); AST and ALT ≤2.5×ULN (≤5.0×ULN if liver metastases present)

Cardiac function

LVEF < 50% within 6 months prior to first dose; clinically significant history of QTc prolongation, second-degree type II or third-degree AV block, QTc interval (Fridericia's method) > 470 ms (female) or > 480 ms (male); arrhythmia requiring treatment; uncontrolled hypertension

Bone marrow and organ function meeting the following criteria (without blood transfusion, G-CSF, or medication correction within 14 days prior to screening): ... Liver function: Total serum bilirubin ≤1.5×ULN (≤3.0×ULN if liver metastases present); AST and ALT ≤2.5×ULN (≤5.0×ULN if liver metastases present). Coagulation function: INR and aPTT ≤1.5×ULN. Renal function: Serum creatinine ≤1.5×ULN or estimated creatinine clearance ≥60 mL/min. Cardiac: LVEF < 50% within 6 months prior to first dose; QTc prolongation, AV block, arrhythmia, uncontrolled hypertension.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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