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临床试验/NCT07271498
NCT07271498已完成不适用

"Oral Chronic Graft-Versus-Host Disease (cGVHD) as a Potential Clinical Marker of the Graft-Versus-Leukemia (GVL) Effect in Allogeneic Hematopoietic Stem Cell Transplantation:Prospective Single-Center Study"

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2023年10月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
93
试验地点
1
主要终点
Overall survival

研究概览

简要总结

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is the standard treatment for many malignant blood disorders. Its effectiveness is based on the graft-versus-leukemia (GVL) effect, which is intrinsically linked to the occurrence of graft-versus-host disease (GVHD). While GVHD reflects favorable alloreactivity, its severe forms increase While GVHD reflects favorable allograft reactivity, its severe forms increase non-relapse mortality (NRM) and impair quality of life. Currently, there is no simple clinical marker that can predict or monitor the efficacy of the GVL effect. The investigators therefore hypothesized that chronic oral GVHD, a common and easily identifiable manifestation, could reflect beneficial alloreactivity, reflecting a balance between GVL effect and toxicity. The investigators conducted a prospective, observational, single-center study including patients transplanted at the Nice University Hospital between October 2023 and May 2025, followed by a standardized stomatological protocol before and after transplantation.

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who received an allograft between octobre 2023 and May 2025 at CHU de Nice.

排除标准

  • Patients who did not received an allograft

结局指标

主要结局

Overall survival

时间窗: 3 months, 6 months, 1 years and 1,5 years

Overall Survival (OS) is defined as the time, measured in months, from the date of study entry (or randomization, depending on protocol specifications) to death from any cause. Participants who are alive at the time of the last known follow-up are censored at that date.

次要结局

  • Disease free survival,(3 months, 6 months, 1 years and 1,5 years)
  • Non relapse mortality(3 months, 6 months, 1 years and 1,5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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