A Prospective, Multicenter, Randomized Controlled Trial Comparing the Efficacy and Safety of Etoposide, Cytarabine, and PEG-rhG-CSF Combination Therapy vs. Disease-Specific Chemotherapy for Hematopoietic Stem Cell Mobilization in Lymphoma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 99
- 试验地点
- 17
- 主要终点
- % of patients achieving the collection of ≥5×10^6 CD34+ cells/kg
研究概览
简要总结
This study utilizes a prospective, multicenter, randomized two-arm design to evaluate the efficacy and safety of the etoposide, cytarabine, and pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) combination therapy (EAP regimen) in mobilizing hematopoietic stem cells in patients with non-Hodgkin's lymphoma (NHL). A total of 99 NHL patients will be enrolled as research subjects and will be randomly allocated in a 2:1 ratio to compare the EAP regimen versus disease-specific chemotherapy mobilization regimen. The primary endpoint is the proportion of patients achieving the ideal collection value after a single collection (CD34+ cells ≥5×10^6/kg).
详细描述
Based on strict inclusion and exclusion criteria, a total of 99 non-Hodgkin's lymphoma patients from 16 hospitals will be selected. Eligible subjects will be randomly assigned in a 2:1 ratio to either the experimental group or the control group. The experimental group will receive the EAP regimen, which combines etoposide, cytarabine, and pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF), while the control group will receive disease-specific chemotherapy mobilization regimens, such as the CHOP and Hyper-CVAD. Subsequently, the number of CD34+ cells will be monitored. The study will evaluate the proportion of patients achieving the ideal collection value after a single collection (CD34+ cells ≥5×106/kg); the proportion of patients achieving the target collection value cumulatively; the total amount of CD34+ cells collected and the average number of collections; hematological and non-hematological adverse reactions; and the proportion of patients receiving plerixafor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Diagnosed with non-Hodgkin's lymphoma before enrollment.
- •Indication for autologous stem cell transplantation (ASCT).
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0~
- •Achieved complete remission after multiple courses of chemotherapy.
- •Life expectancy ≥ 3 months.
- •Subjects must be able to understand the protocol and sign the informed consent.
排除标准
- •Cardiac function class II or higher or cardiac ejection fraction < 40%.
- •Serum direct bilirubin (DBIL) more than twice of the upper limit of normal (ULN).
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) more than three times the upper limit of normal (ULN).
- •Serum creatinine clearance rate ≤ 50%.
- •Patients with active infection.
- •History of prior hematopoietic stem cell mobilization.
研究组 & 干预措施
EAP regimen group
66 subjects will be enrolled into the EAP regimen group. EAP regimen is the etoposide, cytarabine, and PEG-rhG-CSF combination therapy.
干预措施: Etoposide (Drug)
EAP regimen group
66 subjects will be enrolled into the EAP regimen group. EAP regimen is the etoposide, cytarabine, and PEG-rhG-CSF combination therapy.
干预措施: Cytarabine (Drug)
EAP regimen group
66 subjects will be enrolled into the EAP regimen group. EAP regimen is the etoposide, cytarabine, and PEG-rhG-CSF combination therapy.
干预措施: PEG-rhG-CSF (Drug)
EAP regimen group
66 subjects will be enrolled into the EAP regimen group. EAP regimen is the etoposide, cytarabine, and PEG-rhG-CSF combination therapy.
干预措施: G-CSF (Drug)
Disease-specific chemotherapy mobilization regimens group
33 subjects will be enrolled into the disease-specific chemotherapy mobilization regimens group. The disease-specific chemotherapy mobilization regimens include but not limited to: CHOP, Hyper-CVAD, ID-MTX+Ara-C.
干预措施: CHOP (Combination Product)
Disease-specific chemotherapy mobilization regimens group
33 subjects will be enrolled into the disease-specific chemotherapy mobilization regimens group. The disease-specific chemotherapy mobilization regimens include but not limited to: CHOP, Hyper-CVAD, ID-MTX+Ara-C.
干预措施: Hyper-CVAD (Combination Product)
Disease-specific chemotherapy mobilization regimens group
33 subjects will be enrolled into the disease-specific chemotherapy mobilization regimens group. The disease-specific chemotherapy mobilization regimens include but not limited to: CHOP, Hyper-CVAD, ID-MTX+Ara-C.
干预措施: ID-MTX + Ara-C (Combination Product)
Disease-specific chemotherapy mobilization regimens group
33 subjects will be enrolled into the disease-specific chemotherapy mobilization regimens group. The disease-specific chemotherapy mobilization regimens include but not limited to: CHOP, Hyper-CVAD, ID-MTX+Ara-C.
干预措施: DA-EPOCH (Combination Product)
Disease-specific chemotherapy mobilization regimens group
33 subjects will be enrolled into the disease-specific chemotherapy mobilization regimens group. The disease-specific chemotherapy mobilization regimens include but not limited to: CHOP, Hyper-CVAD, ID-MTX+Ara-C.
干预措施: GDP (Combination Product)
Disease-specific chemotherapy mobilization regimens group
33 subjects will be enrolled into the disease-specific chemotherapy mobilization regimens group. The disease-specific chemotherapy mobilization regimens include but not limited to: CHOP, Hyper-CVAD, ID-MTX+Ara-C.
干预措施: GDPE (Combination Product)
Disease-specific chemotherapy mobilization regimens group
33 subjects will be enrolled into the disease-specific chemotherapy mobilization regimens group. The disease-specific chemotherapy mobilization regimens include but not limited to: CHOP, Hyper-CVAD, ID-MTX+Ara-C.
干预措施: ICE (Combination Product)
Disease-specific chemotherapy mobilization regimens group
33 subjects will be enrolled into the disease-specific chemotherapy mobilization regimens group. The disease-specific chemotherapy mobilization regimens include but not limited to: CHOP, Hyper-CVAD, ID-MTX+Ara-C.
干预措施: DICE (Combination Product)
Disease-specific chemotherapy mobilization regimens group
33 subjects will be enrolled into the disease-specific chemotherapy mobilization regimens group. The disease-specific chemotherapy mobilization regimens include but not limited to: CHOP, Hyper-CVAD, ID-MTX+Ara-C.
干预措施: G-CSF (Drug)
结局指标
主要结局
% of patients achieving the collection of ≥5×10^6 CD34+ cells/kg
时间窗: 1 month
Proportion of patients who achieve the ideal collection value (CD34+ cells ≥5×10\^6/kg) after a single collection.
次要结局
- % of patients achieving the collection of ≥2×10^6 CD34+ cells/kg(1 month)
- Adverse Rvents (AEs)(1 month)
- CD34+ cells and the average number of collections(1 month)
- % of patients who use Plerixafor(1 month)