NCT07744737尚未招募2 期
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
Changzhou No.2 People's Hospital1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2026年7月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Complete Response Rate (CRR) after 6 cycles of induction therapy
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Pirtobrutinib+R-CHOP for newly diagnosed non GCB DLBCL
Experimental
This single-arm, open-label, multicenter study evaluates pirtobrutinib plus R-CHOP in untreated Non-GCB DLBCL. PET/CT is performed after 3 cycles; CR/PR patients continue for 3 more cycles, while PD/SD patients discontinue. Post-6-cycle CR/PR patients proceed to autologous HSCT if eligible, or pirtobrutinib maintenance (200 mg qd) for 6 months otherwise. Follow-up includes PET/CT or contrast-enhanced CT every 3 months in Year 1 and every 6 months thereafter until progression, death, consent withdrawal, or study end, whichever comes first.
干预措施: Pirtobrutinib plus R-CHOP (Drug)
结局指标
主要结局
Complete Response Rate (CRR) after 6 cycles of induction therapy
时间窗: week 18，at the end of 6 cycles of induction therapy（each cycle is 21 days）
次要结局
- Objective Response Rate (ORR) after 6 cycles of induction therapy(week 18，at the end of induction therapy(each cycle is 21 days))
- Overall Survival (OS)(up to 3 years)
- Progression-Free Survival(PFS)(up to 3 years)
- Number of participants with treatment-related adverse events (TRAEs) as assessed by CTCAE v5.0(up to 3 years)
研究者
Lu Xuzhang
Principal Investigator
Changzhou No.2 People's Hospital
研究点 (1)
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