NCT06743945招募中2 期
A Prospective, Multicenter, Phase II Study of POLA-R-CHP in the First-line Treatment of Transformed DLBCL
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 2-year progression-free survival (PFS) assessed by imaging examination
研究概览
简要总结
This study aims to evaluate efficacy and safety of POLA-R-CHP in the treatment of patients with transformed DLBCL.
详细描述
Patients with transformed DLBCL lack standard treatment. We intend to conduct a prospective, multicenter, phase II study in order to evaluate efficacy and safety of POLA-R-CHP as first-line treatment of patients with transformed 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
- •Age 18 -80 years old;
- •Histologically confirmed transformed DLBCL;
- •ECOG 0-2;
- •Signed informed consent form.
- •Having sufficient organ function: a) Hematopoietic function: Neutrophils ≥ 1.0 × 109/L, PLT ≥ 75 × 109/L, Hb ≥ 90g/L(unless caused by underlying disease, as judged by the investigator, such as extensive bone marrow involvement, or hypersplenism secondary to lymphoma splenic involvement); b) Liver function: bilirubin ≤1.5 times the upper limit of normal (ULN), ALT and AST<3 x ULN, serum albumin ≥ 30 g/L; c) Renal function: serum Cr<1.5 × ULN, creatinine clearance rate ≥ 50mL/min (calculated according to the standard Cockcroft Gault formula, if renal dysfunction is caused by tumor compression, creatinine clearance rate ≥ 30mL/min); d) Left ventricular ejection fraction (LVEF) ≥ 50% detected by echocardiography.
排除标准
- •Individuals who are allergic to human or mouse monoclonal antibodies, or known sensitivity or allergic reaction to murine products;
- •Previous organ transplantation;
- •Prior treatment of any condition (e.g., cancer, rheumatoid arthritis) with cytotoxic drugs within 5 years at the time of screening or prior use of any anti-CD20 antibodies;
- •Evidence of uncontrolled significant comorbidities that may affect the patient's compliance with the study protocol or affect the interpretation of the study results, including significant cardiovascular disease (such as New York College of Cardiology Class III or IV heart disease, myocardial infarction within the past 6 months, unstable arrhythmia, or unstable angina) or pulmonary disease (including history of obstructive pulmonary disease and bronchospasm);
- •Recent major surgery (within 4 weeks prior to enrollment), excluding diagnostic surgery;
- •Known active bacterial, viral, fungal, mycobacterial, parasitic or other infections (except for fungal infections in nail beds) at the time of study enrollment or major infections within 2 weeks before the start of the first course of treatment;
- •Previous radiotherapy in the mediastinum/pericardial region;
- •Active chronic hepatitis B infection (defined as HBV DNA positive): If hepatitis B virus (HBV) DNA cannot be detected during screening, patients with latent or previous hepatitis B infection (defined as positive hepatitis B surface antigen or hepatitis B core total antibody) can be included in this study. The above patients must voluntarily undergo regular HBV-DNA testing and receive appropriate antiviral treatment according to regulations.
- •For patients with positive hepatitis C virus (HCV) antibody serological test, only when polymerase chain reaction (PCR) shows negative HCV-RNA can participate in this study.
- •Patients with active HIV and syphilis infections;
- •Pregnant or lactating women;
- •The researcher determined that patients are not suitable to participate in this study.
研究组 & 干预措施
Experimental group
Experimental
POLA-R-CHP
干预措施: POLA-R-CHP (Drug)
结局指标
主要结局
2-year progression-free survival (PFS) assessed by imaging examination
时间窗: From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
the period from the date of patients sign informed consent to the observed progression of the disease or the occurrence of death for any reason
次要结局
- complete remission rate assessed by imaging examination(up to 6 months)
- 2-year event-free survival (EFS)(From date of patients sign informed consent until the date of first documented event, progression or date of death from any cause, whichever came first, assessed up to 2 years)
- 2-year overall survival rate(From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 2 years)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(Through study completion, up to 2 years)
研究者
Yizhen Liu
Clinical Professor
Fudan University
研究点 (1)
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