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临床试验/NCT06362720
NCT06362720尚未招募不适用

The Comparison the CMV Infection and Reactivation After Allogeneic Hematopoietic Stem Cell Transplantation Between Standard Regimen, Methotrexate Plus Cyclosporin A, and Post-transplant Cyclophosphamide-based Regimen

Siriraj Hospital0 个研究点目标入组 158 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
158
主要终点
Number of participants with CMV infection and reactivation

研究概览

简要总结

The goal of this observational study is to compare the CMV infection and reactivation after allogeneic hematopoietic stem cell transplantation Between Standard Regimen, Methotrexate plus Cyclosporin A, and Post-transplant Cyclophosphamide-based Regimen. The main questions it aims to answer are:

  • How do CMV infection and reactivation differ between Allo-SCT patients who received a standard regimen versus those who received a Post-transplant Cyclophosphamide-based regimen?
  • progression-free survival, Median overall survival, cumulative incidence of relapse, non-relapsed mortality (NRM) and GvHD at 2 years after Allo-SCT
  • The impact of CMV infection and CMV reactivation on progression-free survival, overall survival, and NRM
  • Averse events of GVHD prophylaxis medication Participants will be collected the data of treatment and treatment response during transplant until 2 years after transplant from hospital medical record.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age more than 15 years
  • Diagnosis of acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML), chronic lymphocytic leukemia (CLL), chronic myelomonocytic leukemia (CMML), myelodysplastic syndrome (MDS), myelofibrosis primary and/or post PV/ET myelofibrosis, aplastic anemia, lymphoma, or paroxysmal nocturnal hemoglobinuria
  • Received HLA-matched related (MSD-HSCT) or unrelated allo-SCT (MUD-HSCT) or haploidentical hematopoietic stem cell transplantation

排除标准

  • Insufficient data needed for analysis

结局指标

主要结局

Number of participants with CMV infection and reactivation

时间窗: 14 days to 6 months after transplant

Number of participants with CMV infection and reactivation after allogeneic hematopoietic stem cell transplantation Between Standard Regimen, Methotrexate plus Cyclosporin A, and Post-transplant Cyclophosphamide-based Regimen

次要结局

  • GvHD(at 2 years after transplant)
  • Averse events(at 2 years after transplant)
  • cumulative incidence of relapse(at 2 years after transplant)
  • progression-free survival(at 2 years after transplant)
  • non-relapsed mortality(at 2 years after transplant)
  • Median overall survival(at 2 years after transplant)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chutima Kunacheewa

lecturer

Siriraj Hospital

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