Haplo-identical HSCT Versus Chemotherapy for Adult Acute Lymphoblastic Leukemia Patients
Phase III Study to Compare Haplo-identical HSCT Versus Chemotherapy in First Remission for Standard-risk Adult Acute Lymphoblastic Leukemia
研究概览
详细说明
Although the high complete remission rate (80%-90%) can be achieved, the long-term survival rate of standard-risk adult patients with acute lymphoblastic leukemia(ALL) is only 25%-55% when they receive chemotherapy alone. The survival rate can be further improved uo to 50%-75% when they receive HLA-matched HSCT However, the chance of finding a HLA-matched donor is low, especially in China. Alternative donor such as halpo-identical related donor might be an choice.
Our retrospective analysis showed about 59% overall survival could be achieved when standard-risk adult ALL patients received halpo-identical HSCT.Therefore, we start this randomization controlled trial to compare the efficacy of haplo-identical HSCT with chemotherapy for adult(age:18-39 years old) ALL patients in CR1.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Beijing、中国
- Peking Union hospital
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Beijing、中国
- General Hospital of PLA
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Beijing
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Beijing、Beijing、中国、100044
- Aerospace Center Hospital
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Hubei
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Wuhan、Hubei、中国
- Wuhan Union Hospital
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Jiangsu
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Suzhou、Jiangsu、中国
- The First Affiliated Hospital Of Soochow University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- acute lymphoblastic leukemia
- 18-39 years old
- in first complete remission -Adequate hepatic function defined as: total bilirubin ≤2.0 times the institutional upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase(AST) ≤2.5 times the institutional ULN -
- Adequate renal function defined as creatinine ≤3 times the institutional ULN
- No uncontrollable infection
- Performance Status(PS)score 0-2(WHO)
- Subjects able to provide written informed consent
Exclusion Criteria:
- having HLA-matched donor
- high-risk ALL: (1)Ph+ALL (2)Hypodiploidy (3)t(v;11q23) (4) complex karyotype(≥5 chromosome abnormalities)(5)high white blood cell (WBC) count (B-ALL≥30×109/L;T-ALL ≥100×109/L).
- pregnancy
- Loss of ability to freely provide consent due to psychiatric or physical illness
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:chemotherapy
Drugs: Drug:Methotrexate 1g/m2 d1,IV (in the vein) , used in cycle 1,3,5 Drug:arabinoside 2-3g/m2,q12h, d2-3, IV, used in cycle 1,3,5 Drug:cyclophosphamide:300mg/m2 q12h, d1-3, IV,used in cycle 2,4,6 Drug:Epirubicin 60mg/m2.d,d4,used in cycle 2,4,6 Drug:Vindesin 4mg/d,d4,d11, IV,in cycle 2,4,6 Drug:dexamethasone 40mg/d,d1-4,d11-14, IV, in cycle 2,4,6 Drug:Methotrexate 20 mg/m2/w,po, during maintenance treatment for 2 years Drug:6-mercaptopurine 60 mg/m2/d,po,d1-d28,during maintenance treatment for 2 years Drug:Vindesin 4mg/d,Predisone:1mg/kg, d1-7, every month during maintenance treatment for 2 years |
Patients receive 6 cycles of consolidation chemotherapy after randomization, including Hyper-CVAD-B regimen-Hyper-CVAD-A regimen/Hyper-CVAD-B regimen/Hyper-CVAD-A regimen/Hyper-CVAD-B regimen/Hyper-CVAD-A regimen.Maintenance treatment includes MTX 20mg/m2/w,po,6-mercaptopurine 60 mg/m2/d,po,d1-d28,VP(VDS 4mg,d1, Prednisone 1mg/kg d1-7) every one month for 2 years.
其他名称:
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实验性的:Haplo-identical HSCT
Haplo-identical HSCT Protocol:G, donor treatment with recombinant granulocyte colony-stimulating factor (rhG-CSF); I, intensified immunologic suppression; A, antihuman thymocyte immunoglobulin (ATG) for the prevention of GVHD; C, combination of peripheral blood stem cell transplantation (PBSCT), and bone marrow transplantation (BMT),named GIAC regimen.
Graft versus-host disease(GVHD) prevention regimen: CSA/MMF/MTX, cyclosporine A(CSA) 1.25mg/kg/d, i.v administrated in two doses from day -109 until bowel function returned to normal, at which time patients receive oral CSA until 12months after HSCt and then gradually tapered.
Every 12h, 0.5g mycophenolate mofetil (MMF)(0.25g
for children) was administrated orally from day -10 to +30 and subsequently 0.25g from days +30 to +60.
Methotrexate (MTX) was administrated at a dose of 15mg/m2 on day +1 and 10mg/m2 on days +3,+6, and +11.
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Haplo-identical Protocol: myeloablative human leukocyte antigen (HLA) haploidentical stem cell transplantation (haplo-SCT) using pretransplant ATG and granulocyte colony-stimulating factor (G-CSF)-stimulated grafts (ATG+G-CSF) GVHD prevention regimen: CSA/MMF/MTX, CSA 1.25mg/kg/d, i.v administrated in two doses from day -109 until bowel function returned to normal, at which time patients receive oral CSA until 12months after HRD-HSC and then gradually tapered.
Every 12h, 0.5g MMF(0.25g for children) was administrated orally from day -10 to +30 and subsequently 0.25g from days +30 to +60.
MTX was administrated at a dose of 15mg/m2 on day +1 and 10mg/m2 on days +3,+6, and +11.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Disease-free survival
大体时间:At 2 years from study entry
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At 2 years from study entry
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次要结果测量
结果测量 |
大体时间 |
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累积复发率
大体时间:入学后 2 年
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入学后 2 年
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Overall survival (OS) rate
大体时间:At 2 years from study entry
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At 2 years from study entry
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nonrelapse mortality
大体时间:At 2 years from study entry
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At 2 years from study entry
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合作者和调查者
合作者
调查人员
- 首席研究员:Xiao-Jun Huang, MD、Peking University People's Hospital
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
- 免疫系统疾病
- 组织学类型的肿瘤
- 肿瘤
- 淋巴增生性疾病
- 淋巴系统疾病
- 免疫增生性疾病
- 白血病
- 前体细胞淋巴细胞白血病-淋巴瘤
- 白血病、淋巴细胞
- 药物的生理作用
- 药理作用的分子机制
- 自主代理
- 周围神经系统药物
- 核酸合成抑制剂
- 酶抑制剂
- 抗炎药
- 抗风湿药
- 抗代谢药、抗肿瘤药
- 抗代谢物
- 抗肿瘤药
- 免疫抑制剂
- 免疫因素
- 止吐药
- 胃肠道药物
- 糖皮质激素
- 荷尔蒙
- 激素、激素替代品和激素拮抗剂
- 抗肿瘤药,激素
- 抗肿瘤药,烷基化
- 烷化剂
- 清髓性激动剂
- 拓扑异构酶 II 抑制剂
- 拓扑异构酶抑制剂
- 皮肤病药物
- 抗生素、抗肿瘤药
- 生殖控制剂
- 堕胎药,非甾体
- 堕胎剂
- 叶酸拮抗剂
- 地塞米松
- 环磷酰胺
- 表柔比星
- 甲氨蝶呤
- 巯嘌呤
其他研究编号
- ALL-13
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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急性淋巴细胞白血病的临床试验
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Shenzhen Second People's Hospital招聘中白血病 | 骨髓的 | 慢性的 | BCR-ABL (Breakpoint Cluster Region-abelson Murine Leukemia) | 积极的中国