NL-OMON25024招募中不适用
A randomized phase II multicenter study with a safety run-in to assess the tolerability and efficacy of the addition of oral selinexor (KPT-330) to standard induction chemotherapy in AML and high risk myelodysplasia (MDS) (IPSS-R > 4.5) in patients aged ¡Ý 66 years .
HOVON Data Center0 个研究点目标入组 230 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 230
研究概览
简要总结
/A
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients eligible for standard chemotherapy.
- •Patients 66 years and older
排除标准
- •Acute promyelocytic leukemia
- •Patients previously treated for AML (any antileukemic therapy including investigational agents), a short treatment period (< 2 weeks) with Hydroxyurea is allowed
研究者
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进行中（未招募）
不适用
Stuyd for the treatment of patients with leukemic cells (cancer) in their bone marrowpatients = 66 years with:o a diagnosis of AML and related precursor neoplasms according to WHO 2008 classification (excluding acute promyelocytic leukemia) including secondary AML (after an antecedent hematological disease (e.g. MDS) and therapy-related AML, oro acute leukemia's of ambiguous lineage according to WHO 2008 oro a diagnosis of refractory anemia with excess of blasts (MDS) and IPSS-R > 4.5MedDRA version: 17.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: LLTClassification code 10037803Term: RAEBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2009-014455-68-BEHOVON Foundation240