中等剂量 ARA-C 联合自体 SCT 巩固低/中危 AML 的可行性研究 (ICAML2015)
2017年2月1日 更新者:International Consortium on Acute Leukemias
使用中剂量阿糖胞苷联合自体造血干细胞巩固治疗患有低危或中危新发急性髓性白血病的年轻成人的可行性研究
在发展中国家建立一个机构网络,根据通用方案进行 AML 诊断、风险分类、治疗、支持性护理和后续评估,并将使用通用临床研究表格 (CRF) 在单一数据库中注册数据,并可在互联网。
研究概览
地位
未知
条件
详细说明
- 比较在参与的南美医院治疗的根据欧洲白血病网分类的急性髓性白血病患者的总生存期和无病生存期与发达国家报告的结果。
- 比较低危或中危 AML 患者接受两个周期的中等剂量阿糖胞苷治疗与一个周期相同剂量的阿糖胞苷治疗后进行自体 SCT 作为巩固治疗的总生存期和无病生存期。 风险将根据欧洲白血病网的分类确定。
- 在发展中国家创建一个机构网络,根据通用协议执行 AML 诊断、风险分类、治疗、支持性护理和后续评估,并将使用通用临床研究表格 (CRF) 在单一数据库中注册数据,并可在互联网
- 使用国家参考实验室,为参与网络的所有机构提供细胞遗传学和分子方法,从而根据欧洲白血病网结构对 AML 病例进行快速诊断和风险分层;
- 开发一种适合当地资源并能够指导治疗决策的基于流式细胞术的微小残留病评估方法;
- 确定以下时间间隔: a) 诊断和风险组确定; b) 第一周期巩固化疗和自体造血干细胞输注;
- 确定与治疗相关的感染频率和病原体,以及因中性粒细胞减少症发作而住院的次数和平均持续时间;
- 在不同治疗时间创建 AML 患者骨髓样本库;
- 确定无病生存率以及复发和非复发死亡率的累积发生率,并在单独化疗和化疗加自体 SCT 队列之间进行比较。
研究类型
观察性的
注册 (预期的)
547
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
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Rio Grande do Sul
-
Porto Alegre、Rio Grande do Sul、巴西
- 招聘中
- Hospital das Clinicas de Porto Alegre
-
接触:
- Rosane I Bittencourt, MD
- 邮箱:rbittencourt@hcpa.edu.br
-
首席研究员:
- Rosane I Bittencourt, MD
-
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São Paulo
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Campinas、São Paulo、巴西
- 招聘中
- Hospital das Clínicas da UNICAMP
-
接触:
- Katia BB Pagnano, MD
- 邮箱:kborgia@unicamp.br
-
首席研究员:
- Katia BB Pagnano, MD
-
Ribeirao Preto、São Paulo、巴西
- 招聘中
- Hospital das Clínicas de Ribeirão Preto
-
接触:
- Luisa CA Koury, MD
- 电话号码:+55-16-98106-9709
- 邮箱:luisa.koury.lk@gmail.com
-
副研究员:
- Luisa CA Koury, MD
-
Santo Andre、São Paulo、巴西
- 招聘中
- Hospital Mario Covas
-
接触:
- Ronald S Pallotta, MD
- 邮箱:rp.cohs@yahoo.com.br
-
首席研究员:
- Ronald S Pallotta, MD
-
Sao Jose do Rio Preto、São Paulo、巴西
- 招聘中
- Hospital de Base de Sao Jose do Rio Preto
-
接触:
- Marcos RP Oltramari, MD
- 邮箱:marcos.oltramari@gmail.com
-
首席研究员:
- Marcos RP Oltramari, MD
-
Sao Paulo、São Paulo、巴西
- 招聘中
- Hospital Sao Paulo
-
接触:
- Thiago R Noronha, MD
- 邮箱:thinoronha@yahoo.com.br
-
副研究员:
- Thiago R Noronha, MD
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
成人急性髓性白血病患者
描述
纳入标准:
- 根据 WHO 标准诊断急性髓性白血病 (AML);
- 先前未治疗的 AML,包括:新发 AML 或继发于骨髓增生异常综合征;
- 不存在 t(15;17) 或 PML-RARA 重排及其变异(急性早幼粒细胞白血病诊断);
- 年龄大于或等于18周岁或小于或等于65周岁;
- 功能状态 ECOG 从 0 到 2;
- 签署知情同意书;
- 能够遵循协议程序;
- 愿意在治疗期间使用节育方法直至结束;
足够的肾功能和肝功能:
- 胆红素≤正常值上限的1.5倍;
- AST 和 ALT ≤ 正常上限的 2.5 倍;
- 肌酐≤ 2.5 毫克/分升。
- 适宜心功能:左心室射血分数≥50%。
排除标准:
- 根据 WHO 标准诊断急性早幼粒细胞白血病 (APL);
- 根据 WHO 标准诊断为不明确谱系的急性白血病、双表型急性白血病或未分化急性白血病;
- 既往接受过 AML 治疗,但使用羟基脲进行细胞减灭治疗除外;
- 年龄大于65岁或小于18岁;
- 功能状态 ECOG 大于 2;
- 不签署知情同意书;
- 无法遵循协议程序;
- 治疗期间不愿采取任何避孕措施的生育女性;
- 对治疗方案中的任何药物过敏;
- HIV 血清学阳性;
与原发疾病 (AML) 无关的肝肾功能改变:
- 胆红素 > 正常值上限的 1.5 倍
- AST 和 ALT > 正常值上限的 2.5 倍
- 肌酐 > 2.5 毫克/分升
n) 心功能改变,LVEF <50%
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
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 |
---|---|---|
无病生存
大体时间:2年
|
从诊断到复发的时间
|
2年
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
总生存期
大体时间:2年
|
从诊断到因任何原因死亡的时间
|
2年
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Eduardo M Rego, MD、University of Sao Paulo
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年12月1日
初级完成 (预期的)
2021年1月1日
研究完成 (预期的)
2022年1月1日
研究注册日期
首次提交
2017年1月13日
首先提交符合 QC 标准的
2017年1月17日
首次发布 (估计)
2017年1月18日
研究记录更新
最后更新发布 (估计)
2017年2月3日
上次提交的符合 QC 标准的更新
2017年2月1日
最后验证
2017年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
急性髓性白血病的临床试验
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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