3 种不同剂量静脉注射白消安的评价 (AAA)
前瞻性和多中心评价 3 种不同剂量的 IV 白消安与氟达拉滨和胸腺球蛋白联合用于预后不良的骨髓恶性肿瘤患者来自匹配的相关或无关供体的同种异体干细胞移植 (SCT) 的调节
Albeit the safety of the stem cell transplantation procedure has been greatly improved, further refining the intensity of the conditioning is an important issue to explore, especially in patients with poor prognosis, the goal being to maintain the very favorable safety profile and improve the disease control. This is the goal our prospective trial; we aim to prospectively evaluate in a prospective multicenter trial the efficacy of different conditioning regimens in patients with high-risk myeloid malignancies.
The study is a phase II trial randomizing patients between a prospective active control arm (BX2) and two experimental arms (BX3 and BX4). A standard group was kept in this clinical trial in order to avoid the limitations induced by the comparison with historical controls in the context of continuously improving practice. Each experimental arm will be conducted in parallel according to a standard phase II trial design.
In addition, this trial will associate four ancillary studies to the main clinical objective: 1/ a prospective assessment of the quality of life of the patients over a period of 2 years 2/ an analysis of the cost effectiveness of the procedure, assessed over a period of 2 years 3/ an observational busulfan pharmacokinetic study 4/ a busulfan pharmacogenomic study
研究概览
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习地点
-
-
-
Marseille、法国、13009
- Institut Paoli Calmettes
-
-
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:
-
Patients with poor prognosis myeloid malignancies:
- Myelodysplastic syndrome,
- Acute Myeloid Leukemia (AML) beyond Complete Response (CR1),
- CR1 AML with poor risk cytogenetics
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Adult patients: aged ≥ 55 years up to 65 or < 55 years not eligible for myeloablative conditioning regimen based on Total Body Irradiation (TBI) or double alkylating agent combinations.
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Availability of a HLA identical sibling or matched unrelated donor (10/10)
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Affiliation to social security
-
Written Informed Consent
Exclusion Criteria:
- History of previous Allo-Hematological Stem Cell Transplantation (HSCT)
- HIV positivity
- Signs of chronic active hepatitis B and/or C
- Evolutive psychiatric disease
- Concomitant neoplastic disease
- Pregnant or lactating woman or without contraception (for child bearing potential wom-en)
- Usual contra-indications for Allo-HSCT
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：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 |
|---|---|
|
有源比较器：BX2
Fludarabine (Fludara®): 30 mg/m2 on D-6, D-5, D-4, D-3 and D-2 Busulfan IV (Busilvex®) : 3.2 mg/kg/d on D-4 and D-3 Thymoglobuline®: 2.5 mg/kg/d on D-3 and D-2 |
其他名称：
|
|
实验性的：BX3
Fludarabine (Fludara®): 30 mg/m² on D-6, D-5, D-4, D-3 and D-2 Busulfan IV (Busilvex®) : 3.2 mg/kg/d on D-5, D-4 and D-3 Thymoglobuline® : 2.5 mg/kg/d on D-3 and D-2 |
其他名称：
|
|
有源比较器：BX4-Suspended
Fludarabine (Fludara®): 30 mg/m²on D-6, D-5, D-4, D-3 and D-2 Busulfan IV (Busilvex®) : 3.2 mg/kg/d on D-6, D-5, D-4 and D-3 Thymoglobuline® : 2.5 mg/kg/d on D-3 and D-2 |
Suspended
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to progression or death
大体时间：up to 2 years
|
2-year progression free survival rates |
up to 2 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
移植物抗宿主病
大体时间：长达 2 年
|
长达 2 年
|
|
|
复发
大体时间：长达 2 年
|
长达 2 年
|
|
|
Time to neutrophil>0.5G/l and platelets>50G/l
大体时间：up to 2 months
|
hematologic recovery |
up to 2 months
|
|
Occurrence of grade 3-4 adverse events according the CTC-AE v4.0 scale
大体时间：up to 6 months
|
safety |
up to 6 months
|
合作者和调查者
调查人员
- 首席研究员：Didier BLAISE, MD PhD、Institut Paoli-Calmettes
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 (估计的)
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
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