A Prospective Study on the Modified DEP Regimen Induction Therapy in Lymphoma Induced Hemophagocytic Lymphohistiocytosis
试验速览
- 阶段
- 3 期
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
This study aimed to investigate the efficacy and safety of pegylated liposomal doxorubicin together with etoposide and methylprednisolone as a induction therapy for lymphoma induced hemophagocytic lymphohistiocytosis.
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Diagnosed as lymphoma-Hemophagocytic Lymphohistiocytosis.
- •2.Patients were older than 2 years of age.
- •3.Estimated survival time ≥ 1 week.
- •4.Cardiac ultrasound LVEF≥50%; No Active bleeding of the internal organs(digestive tract, lung, brain, etc.); If the patient has dyspnea, oxygenation index >
- •5.sign informed consent.
排除标准
- •1.Heart function above grade II (NYHA).
- •2.Accumulated dose of doxorubicin above 400mg/m2 、epirubicin above 750mg/m2、pirarubicin above 800mg/m2 or the patients treated with anthracycline induced cardiovascular disease.
- •3.Pregnancy or lactating Women.
- •4.Allergic to pegylated liposomal doxorubicin or etoposide.
- •5.Active bleeding of the internal organs.
- •6.HIV antibody positivity.
- •7.Acute or chronic active hepatitis B (HBsAg positivity, HBV DNA negative acceptable), acute or chronic active hepatitis C (HCV antibody negatively acceptable; HCV antibody positivity, HCV RNA negative acceptable).
- •8.Participate in other clinical research at the same time.
- •9.The researchers considered that patients are not suitable for the study.
研究组 & 干预措施
DEP regimen
pegylated liposomal doxorubicin, etoposide and methylprednisolone administered in 2 week cycles for 2 cycles
干预措施: Pegylated liposomal doxorubicin (Drug)
DEP regimen
pegylated liposomal doxorubicin, etoposide and methylprednisolone administered in 2 week cycles for 2 cycles
干预措施: Etoposide (Drug)
DEP regimen
pegylated liposomal doxorubicin, etoposide and methylprednisolone administered in 2 week cycles for 2 cycles
干预措施: Methylprednisolone (Drug)
结局指标
主要结局
Response rate
时间窗: Time Frame: 1 years
complete response (CR) and partial response (PR) rates
次要结局
- Response rate of lymphoma(Time Frame: 1 years)
- Overall Survival(Time Frame: 1 years)
- Adverse Events(Time Frame: 1 years)
- Progression Free Survival(Time Frame: 1 years)
研究者
Zhao Wang
Principal Investigator
Beijing Friendship Hospital