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临床试验/NCT01770158
NCT01770158终止不适用

Maintenance Therapy With Histamine Dihydrochloride and Interleukin-2 in Adult Acute Myeloid Leukemia (AML) Patients With Measurable Minimal Residual Disease (MRD)- a Non-interventional Study (NIS)

University of Ulm22 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
8
试验地点
22
主要终点
leukemia-free survival / cumulative incidence of relapse

研究概览

简要总结

This is a non-interventional multi-center study (NIS) in adult patients with AML in first complete remission with measurable minimal residual disease (MRD). Patients are eligible when gene status was already determined for previous induction and consolidation therapy of AML and showed carrier of NPM1, CBFβ-MYH11, or MLL-AF9 mutation. The study objective is to observe the impact of pre-emptive therapy with histamine dihydrochloride (HDC) and interleukin-2 (IL-2) with regard to assess leukemia-free survival/time to relapse and to monitor MRD level trend over time. HDC and IL-2 are approved drugs for AML patients in first complete remission. Therapy is administered for 10 treatment cycles as outlined in the Summary of Product Characteristics.

研究设计

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

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

leukemia-free survival / cumulative incidence of relapse

时间窗: two years

次要结局

  • Overall survival(two years)
  • Toxicity induced by the preemptive treatment with Ceplene and IL-2(18 months)

研究者

发起方
University of Ulm
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jochen Greiner

Prof. Dr. Jochen Greiner

University of Ulm

研究点 (22)

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