NCT06486337招募中2 期
A Single-arm, Multi-center, Prospective Clinical Study of Mitoxantrone Hydrochloride Liposome Injection-based CMOP±R Regimen in the Treatment of Newly Diagnosed Non-Hodgkin's Lymphoma
The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 197 人开始时间: 2024年7月8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
- 招募中
- 发起方
- 入组人数
- 197
- 试验地点
- 1
- 主要终点
- Complete Response Rate (CRR)
研究概览
简要总结
This is a prospective, single arm, multicenter study to evaluate the safety and efficacy of CMOP±R in patients with newly diagnosed non-Hodgkin's lymphoma.
详细描述
This is a single-arm, open label, multi-center clinical study to evaluate the safety and efficacy of mitoxantrone hydrochloride liposome in combination with Cyclophosphamide, Vincristine, Prednisone and/or Rituximab(CMOP±R) in patients with newly diagnosed non-Hodgkin's lymphoma. Mitoxantrone hydrochloride liposome will be given on day 1 at dose of 18 mg/m2 and be combined with cyclophosphamide, vincristine, prednisone and/or Rituximab. Each cycle consists of 28 days. A maximum of 8 cycles(6×CMOP±R+2×R) of therapy are planned.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients fully understand this study, voluntarily participate and sign the informed consent (ICF);
- •Age: 18-75 years old;
- •Expected survival time ≥ 3 months;
- •Histopathologically diagnosed newly diagnosed non-Hodgkin's lymphoma;
- •Must have at least one evaluable or measurable lesion that meets the Lugano 2014 criteria: lymph node lesions, measurable lymph nodes must have a long diameter >1.5cm; non-lymph node lesions, measurable extranodal lesions must have a long diameter >1.0cm;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-
- •Bone marrow function: Absolute neutrophil count (ANC) ≥1.5×10^9/L, Platelet count (PLT) ≥75×10^9/L, Hemoglobin(HB)≥ 80 g/L(Restriction may be relaxed in patients with bone marrow involvement, Absolute neutrophil count (ANC) ≥1.0×10^9/L, Platelet count (PLT) ≥50×10^9/L, Hemoglobin(HB)≥ 75g/L);
- •Liver and kidney function: serum creatinine ≤ 1.5 times the upper limit of normal value; AST and ALT ≤ 2.5 times the upper limit of normal value (for patients with liver invasion ≤ 5 times the upper limit of normal value); total bilirubin ≤ 1.5 times the upper limit of normal value (for patients with liver invasion ≤ 3 times the upper limit of normal value);
排除标准
- •Subjects have previously received anthracyclic drug pretreatment;
- •Hypersensitivity to any study drug or its components;
- •Uncontrollable systemic diseases (such as advanced infection, uncontrollable hypertension, diabetes, etc.);
- •Heart function and disease meet one of the following conditions: a) long QTc syndrome or QTc interval >480 ms; b) complete left bundle branch block, grade II or III atrioventricular block; c) Serious and uncontrolled arrhythmias requiring drug treatment; d) New York Heart Association grade ≥ III; e) Cardiac ejection fraction (LVEF) lower than 50%;f) A history of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically serious pericardial disease, or ECG evidence of acute ischemia or active conduction system abnormalities within 6 months before recruitment.
- •Active hepatitis B and C infection (positive hepatitis B virus surface antigen and more than 1x10^3 copies/mL of hepatitis B virus DNA; more than 1x10^3 copies/mL of hepatitis C virus RNA);
- •Human immunodeficiency virus (HIV) infection (positive HIV antibody);
- •Suffering from other malignant tumors in the past or at the same time (except for effectively controlled non-melanoma skin basal cell carcinoma, breast/cervix carcinoma in situ, and other malignant tumors that have been effectively controlled without treatment in the past five years);
- •Suffering from primary or secondary central nervous system (CNS) lymphoma or a history of CNS lymphoma at the time of recruitment;
- •Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures;
- •Other researchers judge not to Eligibility to participate in this study.
研究组 & 干预措施
CMOP±R
Experimental
All enrolled patients. All patient who signed the consent form for participation to the study.
干预措施: CMOP±R (Drug)
结局指标
主要结局
Complete Response Rate (CRR)
时间窗: 3 years
Response is assessed according to the 2014 lugano criteria.Percentage of participants with complete response was determined on 2014 Lugano criteria.
次要结局
- Changes in cardiac safety indicators(3 years)
- Overall Response Rate (ORR)(3 years)
- Progression-Free-Survival (PFS)(3 years)
- Duration of Response (DOR)(3 years)
- Overall survival (OS)(3 years)
- Progression of disease within 2 years(POD24)(3 years)
- Treatment-emergent adverse events (TEAEs)(From the initiation of the first dose to 28 days after the last dose)
研究者
研究点 (1)
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