Pirtobrutinib + R-CHOP for Untreated Non-GCB DLBCL

Официальное название

A Prospective, Multicenter Clinical Study of Pirtobrutinib Combined With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) for the Treatment of Previously Untreated Non-GCB DLBCL

Обзор

To evaluate the efficacy and safety of pirtobrutinib combined with R-CHOP in patients with newly diagnosed non-GCB diffuse large B-cell lymphoma (DLBCL)

Вмешательства

• Препарат Pirtobrutinib plus R-CHOP
  The treatment regimen consists of pirtobrutinib 200 mg orally on days 1-21 of each 21-day cycle for 6 cycles, combined with R-CHOP given as follows: rituximab 375 mg/m² intravenously on day 1; cyclophosphamide 750 mg/m² intravenously on day 2; doxorubicin 50 mg/m² intravenously on day 2; vincristine 1.4 mg/m² (maximum 2 mg) intravenously on day 2 for 6 cycles; and prednisone 100 mg orally on days 1-5 of each 21-day cycle for 6 cycles.

Первичные конечные точки

• 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）]

Вторичные конечные точки (4)

• Objective Response Rate (ORR) after 6 cycles of induction therapy [Срок оценки: week 18，at the end of induction therapy(each cycle is 21 days)]
• Overall Survival (OS) [Срок оценки: up to 3 years]
• Progression-Free Survival(PFS) [Срок оценки: up to 3 years]
• Number of participants with treatment-related adverse events (TRAEs) as assessed by CTCAE v5.0 [Срок оценки: up to 3 years]

Критерии участия

Критерии включения

• Histopathologically confirmed non-GCB diffuse large B-cell lymphoma (DLBCL) (per the 2016 WHO diagnostic criteria);
• Whole-body PET/CT performed within 28 days prior to study enrollment demonstrating at least one measurable lesion (per the 2014 Lugano Criteria);
• Age 18-80 years, with estimated survival > 3 months;
• No prior anti-lymphoma treatment;
• Able to provide written informed consent and comply with scheduled study visits and required procedures specified in the protocol;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
• Adequate organ and bone marrow function, defined as follows: Hematology: Absolute neutrophil count (ANC) ≥ 0.5 × 10⁹/L; platelet count (PLT) ≥ 50 × 10⁹/L; hemoglobin (HGB) ≥ 8.0 g/dL. No administration of granulocyte growth factors, platelet transfusions or red blood cell transfusions within 7 days before testing. Liver function: Total serum 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: New York Heart Association (NYHA) functional class < III; left ventricular ejection fraction (LVEF) ≥ 50% on echocardiography. Coagulation function: International normalized ratio (INR) ≤ 1.5 × ULN; activated partial thromboplastin time (APTT) ≤ upper limit of normal +10 s; prothrombin time (PT) ≤ upper limit of normal +3 s. Thyroid function: Baseline thyroid-stimulating hormone (TSH) within normal range, or abnormal baseline TSH with normal T3/T4 and absence of related clinical symptoms.
• Female subjects of childbearing potential, or male subjects whose sexual partners are females of childbearing potential, must adopt effective contraceptive measures throughout the treatment period and for 90 days after the last treatment administration.

Критерии исключения

• Central nervous system involvement;
• History of hypersensitivity to the study drug, similar agents, or excipients;
• Concurrent other malignancies requiring treatment or intervention;
• Major surgical procedure performed within 4 weeks prior to treatment (excluding vascular access catheterization or biopsy);
• Any life-threatening disease, medical condition, or organ dysfunction that, in the Investigator's opinion, may compromise patient safety or adherence to study procedures;
• Poorly controlled cardiac symptoms or diseases, including: i. Heart failure of NYHA Class ≥ II; ii. Unstable angina pectoris; iii. Myocardial infarction within the past 12 months; iv. Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
• Patients with active bleeding;
• Uncontrolled active systemic bacterial, viral, fungal or parasitic infection (excluding fungal nail infection), or other clinically significant active disease process that renders the patient unsuitable for participation in this trial as judged by the Investigator.
• Known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome (AIDS).
• Patients with active chronic hepatitis B or active hepatitis C are excluded.Patients positive for hepatitis B surface antigen, hepatitis B core antibody or hepatitis C virus antibody during screening must undergo further testing for HBV-DNA and HCV-RNA. Patients with stable hepatitis B after antiviral therapy (HBV-DNA < 2500 copies/mL or 500 IU/mL) and cured hepatitis C patients (HCV-RNA below the lower limit of detection) are eligible for enrollment.
• Confirmed prior history of neurological or psychiatric disorders, including epilepsy or dementia;
• Pregnant or lactating women;
• Received any other investigational product within 1 month prior to the first dose;
• Other conditions that, in the Investigator's judgment, may interfere with the evaluation of efficacy or safety of the study treatment.

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: NCT07744737 · 2026CELH026-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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