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 (Jun 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
Treatments studied
Targeted therapy
Other
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)
Demographics
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.
Frequently asked questions
Is NCT07499271 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require TP53?
Yes, TP53 mutation is a required biomarker for enrollment.
Does this trial require MS4A1?
Yes, MS4A1 overexpression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify