Prospective, Single-arm, Multicenter Exploratory Clinical Study of the Combination of Etoposide, Cytarabine and PEG-rhG-CSF (EAP Regimen) on Hematopoietic Stem Cell Mobilization in Poor Mobilization Patients With Hematological Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 62
- 试验地点
- 12
- 主要终点
- % of patients achieving the collection of ≥2×10^6 CD34+ cells/kg.
研究概览
简要总结
This is a single-arm, multicenter, exploratory clinical study to evaluate the safety and efficacy of the combination of etoposide, cytarabine and PEG-rhG-CSF (EAP regimen) on hematopoietic stem cell mobilization in poor mobilization patients with hematological malignancies. All eligible patients will receive EAP regimen treatment, then the number of CD34+ cells and white blood cells will be monitoring. When the collection standard is met, hematopoietic stem cell collection will be started.
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
- •According to the diagnostic criteria of the Italian transplantation working group, patients with multiple myeloma or lymphoma diagnosed as "confirmed poor mobilization" or "predicted poor mobilization".
- •Patients with auto-HSCT indication.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0~
- •Patients should be within age range of ≥18 and ≤75 years old.
- •Life expectancy ≥ 3 months.
- •Patients must be able to sign informed consent.
排除标准
- •Patients with severe cardiac, hepatic or renal insufficiency, such as:
- •Cardiac function class II or higher or severe arrhythmia;
- •Serum direct bilirubin (DBIL)>2× upper limit of normal (ULN);
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2× ULN;
- •Serum creatinine clearance rate≤50%.
- •Patients with active infection.
- •History of allergy to Etoposide (VP-16), Cytarabine (Ara-C), or PEG-rhG-CSF.
- •Women who are pregnant or breastfeeding.
- •Have received live vaccine and attenuated live vaccine within 4 weeks before enrollment.
- •For any other reasons, the patients are believed not suitable for participation in this study by investigators
研究组 & 干预措施
EAP regimen
The combination regimen of etoposide, cytarabine and PEG-rhG-CSF.
干预措施: Etoposide (Drug)
EAP regimen
The combination regimen of etoposide, cytarabine and PEG-rhG-CSF.
干预措施: Cytarabine (Drug)
EAP regimen
The combination regimen of etoposide, cytarabine and PEG-rhG-CSF.
干预措施: PEG-rhG-CSF (Drug)
结局指标
主要结局
% of patients achieving the collection of ≥2×10^6 CD34+ cells/kg.
时间窗: 4 weeks
The proportion of patients whose cells can be successfully mobilized and collected with a target CD34+ Hematopoietic Stem Cell (HSC) dose of ≥2×10\^6/kg.
次要结局
- % of patients achieving the collection of >5×10^6 CD34+ cells/kg.(4 weeks)
- TRAEs(4 weeks)
- Time from PEG-rhG-CSF mobilization to HSC collection.(4 weeks)
- The average collection times of EAP regimen(4 weeks)
- Hematopoietic reconstitution and therapeutic adverse events after transplantation(4 weeks)