Pirtobrutinib+Pola-R-CHP for Newly Diagnosed Non-GCB DLBCL

Официальное название

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)

Обзор

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.

Вмешательства

• Препарат Pirtobrutinib+Pola-R-CHP
  Pirtobrutinib 200 mg once daily Polatuzumab vedotin 1.8 mg/kg intravenously on Day 1 Rituximab 375 mg/m² on Day 1 Cyclophosphamide 750 mg/m² on Day 1 Doxorubicin 50 mg/m² on Day 1 Prednisone 100 mg on Days 1 to 5 Each cycle lasts 21 days. PET/CT evaluation is conducted after 3 treatment cycles. Subjects who attain CR or PR will receive an additional 3 cycles of therapy. Subjects with PD or SD will be withdrawn from the study. Subjects who do not achieve CR or PR upon completion of 6 cycles will

Первичные конечные точки

• 2-year progression-free survival (PFS) rate [Срок оценки: 2 years]

Вторичные конечные точки (4)

• Objective Response Rate (ORR) after 6 cycles of induction therapy [Срок оценки: week 18，at the end of 6 cycles of induction therapy(each cycle is 21 days)]
• Complete Response Rate (CRR) after 6 cycles of induction therapy [Срок оценки: week 18, at the end of 6 cycles of induction therapy(each cycle is 21 days)]
• Overall Survival(OS) [Срок оценки: up to 4 years]
• Number of participants with treatment-related adverse events (TRAEs) as assessed by CTCAE v5.0 [Срок оценки: up to 4 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Central nervous system involvement;
• History of hypersensitivity to the study drug, drugs of the same class, or excipients;
• Concurrent malignancy requiring treatment or intervention;
• Major surgery within 4 weeks prior to treatment (excluding vascular access catheter placement or biopsy);
• 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;
• Pregnant or lactating women;
• Receipt of other investigational agents within 1 month prior to first dose;
• Any other factors that, in the investigator's opinion, may affect the evaluation of efficacy or safety in this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Jiangsu Province Hospital The First Affiliated Hospital with Nanjing Medical University — Нанкин

Идентификаторы

NCT: NCT07744724 · 2026CELH025-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗