New lymphoma treatment combining pirtobrutinib with chemotherapy

Trial details

Who runs it

Changzhou No.2 People's Hospital

Trial code

NCT07744724

Record updated

6 August 2026

Original description

This is a single-arm, open-label, multicenter clinical study evaluating the efficacy and safety of pirtobrutinib combined with Pola-R-CHP in previously untreated Non-GCB DLBCL. PET/CT assessment will be performed after 3 cycles of combination therapy. Patients achieving CR/PR will continue treatment for another 3 cycles, while those with PD/SD will be discontinued from the study. Patients achieving CR/PR after 6 cycles of treatment will undergo follow-up with PET/CT or contrast-enhanced CT every 3 months during the first year and every 6 months thereafter, until disease progression, death, withdrawal of informed consent, or study completion, whichever occurs first.Read full original descriptionShow less

A Prospective, Multicenter Clinical Study of Pirtobrutinib Combined With Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone (Pola-R-CHP) for Newly Diagnosed Non-GCB Diffuse Large B-Cell Lymphoma (DLBCL)

This is a single-arm, open-label, multicenter clinical study evaluating the efficacy and safety of pirtobrutinib combined with Pola-R-CHP in previously untreated Non-GCB DLBCL. PET/CT assessment will be performed after 3 cycles of combination therapy. Patients achieving CR/PR will continue treatment for another 3 cycles, while those with PD/SD will be discontinued from the study. Patients achieving CR/PR after 6 cycles of treatment will undergo follow-up with PET/CT or contrast-enhanced CT every 3 months during the first year and every 6 months thereafter, until disease progression, death, withdrawal of informed consent, or study completion, whichever occurs first.

Inclusion: Histologically confirmed Non-GCB DLBCL (per 2016 WHO diagnostic criteria); Whole-body PET/CT performed within 28 days prior to study enrollment demonstrating at least one measurable lesion (per 2014 Lugano criteria); Age 18-65 years, with expected survival >3 months; No prior anti-lymphoma treatment; Signed written informed consent and ability to comply with protocol-required visits and procedures; ECOG performance status 0-2; Adequate organ and bone marrow function, defined as follows:; Hematology: Absolute neutrophil count (ANC) ≥1×10⁹/L, platelet count (PLT) ≥50×10⁹/L, hemoglobin (HGB) ≥8.0 g/dL; no granulocyte colony-stimulating factor, platelet transfusion, or red blood cell transfusion within 7 days prior to testing; Hepatic function: Total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; Renal function: Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCR) ≥50 mL/min; Cardiac function: NYHA Class III or below; left ventricular ejection fraction ≥50% by echocardiography; Coagulation: International normalized ratio (INR) ≤1.5×ULN, activated partial thromboplastin time (APTT) ≤ULN +10s, and prothrombin time (PT) ≤ULN +3s; Women of childbearing potential or male subjects with partners of childbearing potential must use effective contraception throughout the treatment period and for 90 days after the last dose.

Exclusion: Concurrent malignancy requiring treatment or intervention; Major surgery within 4 weeks prior to treatment (excluding vascular access catheter placement or biopsy); Receipt of other investigational agents within 1 month prior to first dose; History of hypersensitivity to the study drug, drugs of the same class, or excipients; 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; Uncontrolled cardiac symptoms or disease, including: i. NYHA Class II or higher heart failure; ii. Unstable angina; iii. Myocardial infarction within 1 year; iv. Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; Active bleeding; Active, uncontrolled systemic bacterial, viral, fungal, or parasitic infection (excluding onychomycosis), or other clinically significant active disease process that, in the investigator's opinion, renders the patient unsuitable for clinical trial participation; Known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome; Exclusion of patients with active chronic hepatitis B or active hepatitis C. Patients with positive hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C virus antibody at screening must undergo further HBV-DNA and HCV-RNA testing. Patients with stable hepatitis B (HBV-DNA <2500 copies/mL or 500 IU/mL) on antiviral therapy and cured hepatitis C patients (below the limit of detection) may be enrolled; Definitive history of neurological or psychiatric disorder, including epilepsy or dementia; Central nervous system involvement; Pregnant or lactating women; Any other factors that, in the investigator's opinion, may affect the evaluation of efficacy or safety in this study.

ClinicalTrials.gov NCT07744724