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Safety and Efficacy Study of CNOP Chemotherapy in Diffuse Large B Cell Lymphoma

Safety and Efficacy Study of Mitoxantrone Hydrochloride Liposome Injection Plus Cyclophosphamide,Vincristine and Prednison (CNOP)in Diffuse Large B Cell Lymphoma

The purpose of this study is to determine whether Mitoxantrone Hydrochloride Liposome Injection plus Cyclophosphamide,Vincristine and Prednison(CNOP)is safe and effective in the treatment of Diffuse Large B Cell Lymphoma.

研究概览

详细说明

Mitoxantrone Hydrochloride Liposome Injection is a kind of anthraquinone compounds, and its antineoplastic effect has been viewed in preclinical tests. The investigator´s phaseⅠstudy has shown that the drug´s toxicity is manageable and the tolerable does is 20 mg/m2. The purpose of this study is to determine whether Mitoxantrone Hydrochloride Liposome Injection plus Cyclophosphamide,Vincristine and Prednison(CNOP)is safe and effective in the treatment of Diffuse Large B Cell Lymphoma.Patients physical state, symptoms, changes in the size of the tumor, and laboratory findings obtained while on-study will help the research team decide if Mitoxantrone Hydrochloride Liposome Injection plus Cyclophosphamide,Vincristine and Prednison(CNOP)is safe and effective in the treatment of Diffuse Large B Cell Lymphoma.

研究类型

介入性

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Tianjin、中国
        • Tianjin People's Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 70年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Written informed consent prior to study specific screening procedures;
  • Favorable index of curative effect of Diffuse Large B Cell Lymphoma confirmed by histological analysis;
  • ≥ 18 and ≤ 70 years of age, male or female;
  • Advanced Lymphoma and standard treatments failed;
  • May benefit from anthracycline-based drugs;
  • ECOG performance status of 0-2;
  • More than 4 weeks from the last chemotherapy, more than 4 weeks from the last biotherapy, more than 4 weeks from the last clinical trial drug therapy;
  • Life expectancy of more than 3 months;
  • Sexually active women of childbearing potential must use a medically acceptable form of contraception;
  • Adequate hepatic, renal, cardiac and hematologic functions: leukocyte≥3.5×10^9/L,neutrophils≥2.0×10^9/L,platelets≥100×10^9/L, hemoglobin≥90g/L,creatinine clearance rate≤1.5×ULN, serum bilirubin≤1.5×ULN, ALT≤2.5×ULN(5×for liver metastasis),AST≤2.5×ULN(5×for liver metastasis), alkaline phosphatase≤200 IU/L,Electrocardiogram appeared to be essentially normal, ejection fraction of Heart Doppler ultrasound appeared to be normal.

Exclusion Criteria:

  • Pregnant or lactating women;
  • Patients with Multiple sclerosis;
  • Suffering from serious internal disease, including serious heart attack, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension,uncontrolled infection, Active peptic ulcer;
  • Mitoxantrone has been used before;
  • The cumulative does of doxorubicin and epirubicin before inclusion have surpassed 360 mg/m2 and 600 mg/m2, respectively;
  • Heart disease was caused after Anthracycline-based drugs used;
  • Other antineoplastic drugs need to be used in this study;
  • History of Anthracycline-based drug allergy or liposome drug allergy;
  • Uncontrolled primary brain tumor or brain metastases;

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:非随机化
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Mitoxantrone 12 mg/m2
Mitoxantrone Hydrochloride Liposome Injection 12 mg/m2 will be infused intravenously once over 1 hours in 250 ml 5% glucose injection on the first day during a treatment phase of 3 weeks.
Cyclophosphamide 750 mg/m2 will be infused intravenously once 1-2 minutes in 20-30 ml saline on the first day during a treatment phase of 3 weeks.
Vincristine 0.3-0.5 mg/ml will be infused intravenously once about 5 minutes in saline on the first day during a treatment phase of 3 weeks.
Prednisone 100 mg/d will be taken orally on the first 1-5 day during a treatment phase of 3 weeks.
实验性的:Mitoxantrone 16 mg/m2
Mitoxantrone Hydrochloride Liposome Injection 16 mg/m2 will be infused intravenously once over 1 hours in 250 ml 5% glucose injection on the first day during a treatment phase of 3 weeks.
Cyclophosphamide 750 mg/m2 will be infused intravenously once 1-2 minutes in 20-30 ml saline on the first day during a treatment phase of 3 weeks.
Vincristine 0.3-0.5 mg/ml will be infused intravenously once about 5 minutes in saline on the first day during a treatment phase of 3 weeks.
Prednisone 100 mg/d will be taken orally on the first 1-5 day during a treatment phase of 3 weeks.
实验性的:Mitoxantrone 20mg/m2
Mitoxantrone Hydrochloride Liposome Injection 20 mg/m2 will be infused intravenously once over 1 hours in 250 ml 5% glucose injection on the first day during a treatment phase of 3 weeks.
Cyclophosphamide 750 mg/m2 will be infused intravenously once 1-2 minutes in 20-30 ml saline on the first day during a treatment phase of 3 weeks.
Vincristine 0.3-0.5 mg/ml will be infused intravenously once about 5 minutes in saline on the first day during a treatment phase of 3 weeks.
Prednisone 100 mg/d will be taken orally on the first 1-5 day during a treatment phase of 3 weeks.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
ORR(Objective response rate)
大体时间:12 Weeks
12 Weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Huaqing Wang, Ph.D、Tianjin People's Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年6月1日

初级完成 (预期的)

2016年12月1日

研究完成 (预期的)

2017年6月1日

研究注册日期

首次提交

2015年11月2日

首先提交符合 QC 标准的

2015年11月2日

首次发布 (估计)

2015年11月3日

研究记录更新

最后更新发布 (实际的)

2017年5月23日

上次提交的符合 QC 标准的更新

2017年5月22日

最后验证

2017年5月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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