A Prospective Clinical Study of R-CDOP Regimen in the Treatment of Newly Diagnosed Non-Hodgkin's Lymphoma With High Tumor Burden
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
A single-center, prospective clinical study to evaluate the efficacy and safety of R-CDOP (Rituximab, Cyclophosphamide, Doxorubicin hydrochloride liposome, Vindesine, Prednisone ) in the treatment of newly diagnosed high tumor burden non-Hodgkin's lymphoma, which has previously shown promising efficacy.
详细描述
The objective was to evaluate the efficacy and safety of R-CDOP regimen in the initial treatment of Patients with at least one of the following high tumor burden, and to provide a basis for the application of Doxorubicin hydrochloride liposome.
At least 3 nodal sites (each with a diameter greater than 3 cm) ; Nodal or extranodal mass > 7cm in its greater diameter; Hepatomegaly and splenomegaly (infiltration confirmed by PET-CT; Spleen: female > 15cm, male > 16cm) ; Pleural/peritoneal effusion; Lactate dehydrogenase (LDH) three times the upper limit of normal; PET-CT Total Metabolic Tumor Volume (TMTV)>220cm3.
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
- •Histologically immunohistochemistry and imaging confirmed diffuse large B-cell lymphoma or follicular lymphoma grade 3B;
- •Has at least one evaluable or measurable lesion according to Lugano response criteria;
- •Patients with at least one of the following high tumor burden Involvement of at least 3 nodal sites (each with a diameter greater than 3 cm); nodal or extranodal mass > 7cm in its greater diameter; Hepatomegaly and splenomegaly (infiltration confirmed by PET-CT; Spleen: female > 15cm, male > 16cm); Pleural/peritoneal effusion; Lactate dehydrogenase (LDH) three times the upper limit of normal; PET-CT TMTV >220cm3;
- •Patients previously untreated;
- •Patients aged over 18 and under 75 years;
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0~2;
- •International Prognostic Index (IPI) score > 1, or with extranodal mass diameter ≥7cm;
- •Life expectancy ≥ 6 months;
- •Left Ventricular Ejection Fraction (LVEF) ≥ 50%;
- •Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule.
排除标准
- •Pregnant or lactation and patients of childbearing age who do not want to take contraceptive measures;
- •Abnormal liver function [total bilirubin > 1.5 times of the upper limit of normal value; Alanine aminotransferase/Aspartate aminotransferase (ALT / AST) > 2.5 times of upper limit of normal value for patients without liver metastasis ; ALT / AST > 5 times of upper limit of normal value for patients with liver metastasis ], abnormal renal function (serum creatinine > 1.5 times of upper limit of normal value) ;
- •Absolute Neutrophil Count (ANC)<1.5×10^9/L or Platelet (PLT)< 75 × 10^9/L;
- •Hypersensitivity to any study drug or its ingredients;
- •Patients with significant and uncontrolled cardiovascular disease or history;
- •Persons with mental disorders/unable to obtain informed consent;
- •Lymphoma infiltrates the central nervous system;
- •Previous history of malignant tumor;
- •HIV infection; HBV infection (HBV-DNA> 2000 IU/ml);HCV infection (HCV-RNA>200 IU/ml);
- •The investigator determined not suitable to participate in this study.
结局指标
主要结局
Objective response rate
时间窗: 24 months
Percentage of Complete remission (CR), and Partial remission (PR), referred to Lugano 2014.
次要结局
- Progression-free survival(24 months)
- Overall survival(60 months)
- Adverse Events(24 months)
- Disease Control Rate(24 months)
研究者
oubai, MD/PhD
Director
The First Hospital of Jilin University