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).
Treatment: POLA-R-CHP · Orelabrutinib — 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.
Check if I qualifyExtracted 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
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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