Prospective, Single-arm, Multicenter Exploratory Clinical Study of the Combination of Etoposide, Cytarabine and PEG-rhG-CSF (EAP Regimen) as First Line Mobilization Regimen of Hematopoietic Stem Cells in 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
- 68
- 试验地点
- 14
- 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) as first line mobilization regimen of hematopoietic stem cells in patients with lymphoma and multiple myeloma. 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.
详细描述
In patients older than 65 years, or with creatinine >2.5 mg/dL but with an endogenous creatinine clearance >50%, the dose of etoposide and Ara-C should be reduced by one-quarter to one-third.
Routinely blood analyses and peripheral blood CD34+ cells monitored will be performed daily from day 9 to the end of HSC collection or the abandonment of HSC collection. If the WBC count is ≤10×109/L, 5μg/kg/d of G-CSF should be injected subcutaneously until the end of HSC collection.
Leukapheresis can be performed when the white blood cell counts recover (WBC count was≥4×109/L) following chemotherapy and the CD34+ cell count was≥20/μL. Leukapheresis started if the peripheral blood CD34+ counts plateaued at ≥5 cells/μL and <20 cells/μL after recovery of white blood cell counts following chemotherapy, the clinician decided whether to add plerixafor based on the specific situation of the patient. Leukapheresis should be abandoned if the peak circulating CD34+ cells were <5/μL up to 20 days after chemotherapy. CD34+ cells were determined by multi-parameter flow cytometry and a dual-platform approach. Two blood cell separators were used at the study sites: Spectra-Optia Apheresis system (Terumo BCT, Lake-wood, CO, USA) , COM.TEC (Fresenius Kabi). During each leukapheresis, 2.5 times the patients' blood volume (±25%) had to be processed within 5 h.
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
- •Patients diagnosed as lymphoma or multiple myeloma, with auto-HSCT indication.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0~
- •Life expectancy ≥ 3 months.
- •Subjects must be able to understand the protocol and be willing to enroll the study, sign the informed consent, and be able to comply with the study and follow-up procedures.
排除标准
- •Patients with severe cardiac, hepatic or renal insufficiency, such as:
- •Serum direct bilirubin (DBIL)>2× upper limit of normal (ULN);
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2× ULN;
- •Serum creatinine clearance rate≤50%;
- •Cardiac function class II or higher or severe arrhythmia.
- •History of hematopoietic stem cell mobilization.
- •Patients with active infection.
- •Female subjects who are pregnant or lactating.
- •Subjects with any life-threatening disease, medical condition or organ system dysfunction compromising their safety or causing unnecessary risks for the study results in the investigator' opinion, such as unstable heart disease, stroke, rheumatoid arthritis, lupus.
- •Have received live vaccine and attenuated live vaccine within 4 weeks before enrollment.
- •History of allergy to Etoposide (VP-16), Cytarabine (Ara-C), or PEG-rhG-CSF.
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
- TRAEs(4 weeks)
- Time from PEG-rhG-CSF mobilization to HSC collection.(4 weeks)
- Hematopoietic reconstitution and therapeutic adverse events after transplantation(4 weeks)
- % of patients achieving the collection of #5×10^6 CD34+ cells/kg.(4 weeks)
- The average collection times of EAP scheme(4 weeks)