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)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- 2-year progression-free survival (PFS) rate
研究概览
简要总结
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.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Pirtobrutinib+Pola-R-CHP for newly diagnosed non GCB 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.
干预措施: Pirtobrutinib+Pola-R-CHP (Drug)
结局指标
主要结局
2-year progression-free survival (PFS) rate
时间窗: 2 years
次要结局
- Overall Survival(OS)(up to 4 years)
- Number of participants with treatment-related adverse events (TRAEs) as assessed by CTCAE v5.0(up to 4 years)
- Objective Response Rate (ORR) after 6 cycles of induction therapy(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(week 18, at the end of 6 cycles of induction therapy(each cycle is 21 days))
研究者
Lu Xuzhang
Director, Department of Hematology, Principal Investigator
Changzhou No.2 People's Hospital