The Efficacy and Safety of L-DEP Regimen Combined With PD-1 Antibody an Induction Therapy for Epstein-Barr Virus (EBV)-Positive Lymphoma-associated Hemophagocytic Lymphohistiocytosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Response rate
研究概览
简要总结
The efficacy and safety of L-DEP (aspargase, liposomal doxorubicin, etoposide, and methylprednisolone) regimen combined with PD-1 Antibody an induction therapy for Epstein-Barr virus (EBV)-positive lymphoma-associated hemophagocytic lymphohistiocytosis.
详细描述
Lymphoma-associated hemophagocytic lympohistiocytosis is a refractory immune disorder with high mortality. Without early intervention, the median survival time is less than 2 months. Currently, HLH-94 or HLH-04 are the standard HLH treatment regimens, which have improved the disease response rate to approximately 70% and increased the 5-year OS rate to 50%. However, approximately, 30% of the patients remain unresponsive to standard therapy, especially if HLH is lymphoma-associated. Therefore, we conduct a prospective clinical study to explore the efficacy and safety of L-DEP (aspargase, liposomal doxorubicin, etoposide, and methylprednisolone) regimen combined with PD-1 Antibody an induction therapy for Epstein-Barr virus (EBV)-positive lymphoma-associated 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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as lymphoma-Hemophagocytic Lymphohistiocytosis.
- •EBV-DNA in peripheral blood > 1000 copies/ml or EBER detected in tissue specimens.
- •Age 18~70，gender is not limited.
- •Estimated survival time ≥ 1 month.
- •Cardiac ultrasound LVEF≥50%; No Active bleeding of the internal organs(digestive tract, lung, brain, etc.); If the patient has dyspnea, oxygenation index >
- •Signed informed consent.
排除标准
- •Heart function above grade II (NYHA).
- •Severe myocardial injury：TNT、TNI、CK-MB > 3 ULN.
- •Accumulated dose of doxorubicin above 400mg/m2 、epirubicin above 750mg/m2、pirarubicin above 800mg/m2 or the patients treated with anthracycline induced cardiovascular disease.
- •Pregnancy or lactating Women.
- •Allergic to pegylated liposomal doxorubicin，etoposide，or PD-1 antibody.
- •Thyroid dysfunction.
- •HIV antibody positivity.
- •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).
- •Participate in other clinical research at the same time.
- •The researchers considered that patients are not suitable for the study.
研究组 & 干预措施
L-DEP and PD-1 antibody
aspargase, liposomal doxorubicin, etoposide, and methylprednisolone administered in 2 week cycles for 2 cycles
干预措施: L-DEP and PD-1 antibody (Drug)
结局指标
主要结局
Response rate
时间窗: Two weeks after initiation of L-DEP regimen combined with PD-1 antibody
complete response (CR) and partial response (PR) rates
次要结局
- Overall Survival(1 years)
- Progression Free Survival(1 years)
- Response rate of lymphoma(Four weeks after second cycle of L-DEP and PD-1 antibody regimen)
- Adverse Events(30 days after last administration of cytotoxic drugs)
- EBV-DNA clearance at 2 and 4weeks(4 weeks after induction)
研究者
Zhao Wang
Professor and Head of hematology
Beijing Friendship Hospital