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临床试验/NCT06790680
NCT06790680已完成不适用

Managment of Acute Myeloid Leukemia and Myelodysplastic Patients Relapsing After Allogenic Stem Cell Transplantation: Results of the GITMO AML/MDS-relapse Registry Study

Gruppo Italiano Trapianto di Midollo Osseo1 个研究点 分布在 1 个国家目标入组 859 人开始时间: 2022年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
859
试验地点
1
主要终点
Primary Outcome

研究概览

简要总结

The proposal arises from the increasingly pressing need to have a program of therapy for the prevention of relapse after allogeneic transplantation in patients with acute myeloid leukemia or myelodysplasia, especially if they undergo transplantation with positive minimal residual disease. These therapeutic approaches include molecular target drugs (for example, FLT-3 inhibitors when this gene lesion is present) or apoptosis inducers in combination with hypomethylating agents (for example, the combination of venetoclax and azacitidine or decitabine) or adoptive immunotherapy (for example, with infusion of donor lymphocytes).

To date, most of these therapeutic approaches are used in the phase of hematological relapse of the disease; less often they are used in the phase of persistence of minimal residual disease at the molecular level or in the phase of loss of molecular chimerism on CD34+ cells, also due to the prescribing constraints of the competent authorities (AIFA). It is believed that the collection of the Italian experience can provide important information on the use of different therapeutic platforms, in different settings. This information could be the starting point for the design of prospective and multicenter studies to be proposed in the near future.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •All patients with AML and MDS who underwent allo-SCT from 2015 to 2021, who relapsed and received salvage therapy for the relapse.

排除标准

  • •Patients with a diagnosis other than AML and MDS transplanted in the same period.

结局指标

主要结局

Primary Outcome

时间窗: Through study completion, an avarage 1 year

Complete remission rate after salvage treatment

次要结局

  • Overall survival(Through study completion, an avarage 1 year)

研究者

发起方
Gruppo Italiano Trapianto di Midollo Osseo
申办方类型
Other
责任方
Sponsor

研究点 (1)

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GITMO AML/MDS-Relapse Registry Study | 临床试验