Secondary Haplo HSCT for Relapse After Initial Allogeneic HSCT
2018年5月2日 更新者:University Hospital Tuebingen
Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in the Treatment of Relapse After a First Allogeneic HSCT: a Retrospective Cohort Study by the German Cooperative Transplant Study Group
Relapse of underlying hematologic malignancies after allogeneic hematopoietic stem cell transplantation (HSCT) is frequently treated by a second allogeneic HSCT (HSCT2).
Choosing an alternative donor is often advocated to maximize chances of a graft versus tumour (GVT) effect.
We and others published that success of this strategy when using an alternative human leukocyte antigen (HLA) identical donor is limited, at least when acute leukemia is the underlying disease.
The aggressivity of the rapidly proliferating leukemia seems to prevail over GVT effects.
A more potent alloimmune response is observed following haploidentical HSCT, especially early after haploidentical HSCT.
This might be related to a fast and large expansion of natural killer (NK)-cells.
Their alloreactive effect might translate into higher rates of tumor control.
On the other hand, non-relapse complications (treatment related mortality, TRM) might be high in advanced relapsed tumour patients with heavy pretreatment and due to delayed immune reconstitution after haploidentical HSCT.
The use of a haploidentical donor for HSCT2 following a first allogeneic HSCT from an HLA identical donor has been so far only systematically evaluated in small retrospective single center reports.
Thus, in this multicenter study we aim to collect data on the extent to which participating centers employ haploidentical transplantation in the situation of relapse after HSCT2.
研究概览
地位
完全的
详细说明
Relapse of underlying hematologic malignancies after allogeneic hematopoietic stem cell transplantation (HSCT) is frequently treated by a second allogeneic HSCT (HSCT2).
Choosing an alternative donor is often advocated to maximize chances of a graft versus tumour (GVT) effect.
We and others published that success of this strategy when using an alternative HLA identical donor is limited, at least when acute leukemia is the underlying disease.
The aggressivity of the rapidly proliferating leukemia seems to prevail over GVT effects.
A more potent alloimmune response is observed following haploidentical HSCT, especially early after haploidentical HSCT.
This might be related to a fast and large expansion of NK-cells.
Their alloreactive effect might translate into higher rates of tumor control.
On the other hand, non-relapse complications (treatment related mortality, TRM) might be high in advanced relapsed tumour patients with heavy pretreatment and due to delayed immune reconstitution after haploidentical HSCT.
The use of a haploidentical donor for HSCT2 following a first allogeneic HSCT from an HLA identical donor has been so far only systematically evaluated in small retrospective single center reports.
Thus, in this multicenter study we aim to collect data on the extent to which participating centers employ haploidentical transplantation in the situation of relapse after HSCT2.
We will describe and quantify the specific patient, donor, treatment, graft and outcomes characteristics associated with the course of treatment.
To assess and control for the bias that is associated with the retrospective nature of this study, we will emphasize to collect clearly stated reasons for the decision to use a haploidentical transplant, e.g. as opposed to drug therapy or a second transplant from the original or an alternative HLA identical donor.
This is a retrospective observational cohort study.
German centers performing allogeneic HSCT are asked to contribute.
Data will be validated and missing information will be further retrieved by the four principal investigators through phone.
Final follow up will be performed in April 2014, 2014.
To be able to supply durable data on the primary endpoints, only patients receiving a haploidentical HSCT2 between 01.07.2003 and 30.06.2013 will be included.
研究类型
观察性的
注册 (实际的)
60
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 及以上 (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
非概率样本
研究人群
Patients receiving salvage secondary haploidentical allogeneic HSCT after failure of primary allogeneic HSCT
描述
Inclusion Criteria:
- Age >18 years at time of HSCT2
- Malignant hematologic disease
- Informed consent signed by the patients on the use of data in registry analyses
- 1st allogeneic HSCT performed from any donor, including haploidentical HSCT1
- Hematological or extramedullary relapse after HSCT1
- Haploidentical 2nd allogeneic HSCT (i.e. >= 2 Antigen mismatch family donor) between 01.07.2003 and 30.06.2013
Third or higher allogeneic HSCT does not preclude analysis as long as HSCT2 was haploidentical.
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 |
|---|---|---|
|
Treatment related mortality (TRM) of haploidentical HSCT2
大体时间:up to day 365
|
up to day 365
|
|
|
Toxicity of haploidentical HSCT2
大体时间:up to day 365
|
NCI Common Terminology Criteria for Adverse Events (CTCAE) v.4
|
up to day 365
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
complete remission (CR) rate after haploidentical HSCT2
大体时间:day 100
|
day 100
|
|
Overall survival (OS) at 2 years after haploidentical HSCT2
大体时间:2 years
|
2 years
|
|
Graft versus host disease (GVHD) after haploidentical HSCT2
大体时间:2 years
|
2 years
|
|
Incidence of rejection after haploidentical HSCT2
大体时间:1 year
|
1 year
|
|
Disease free survival (DFS) at 2 years after haploidentical HSCT2
大体时间:2 years
|
2 years
|
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:Wolfgang A Bethge, MD、University Hospital Tuebingen
- 首席研究员:Christoph Schmid, MD、University Hospital Augsburg
- 首席研究员:Johanna Tischer, MD、Ludwig-Maximilians University Hospital Munich
- 首席研究员:Maximilian Christopeit, MD、University Hospital of Halle
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 (实际的)
2013年10月1日
初级完成 (实际的)
2017年12月30日
研究完成 (实际的)
2017年12月30日
研究注册日期
首次提交
2013年10月29日
首先提交符合 QC 标准的
2013年11月27日
首次发布 (估计)
2013年11月28日
研究记录更新
最后更新发布 (实际的)
2018年5月3日
上次提交的符合 QC 标准的更新
2018年5月2日
最后验证
2018年5月1日
更多信息
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