EUCTR2011-003823-36-IT进行中（未招募）不适用
Phase II randomized multicenter study of multiple doses of palonosetron plus aprepitant versus multiple doses of palonosetron alone in preventing chemotherapy-induced nausea and vomiting in patients with newly diagnosed acute myeloid leukaemia or high-risk myelodysplastic syndrome receiving multiple days chemotherapy - Palonosetron + Aprepitant versus Palonosetron alone
ASSOCIAZIONE SALENTINA ANGELA SERRA ONLUS0 个研究点开始时间: 2012年3月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Diagnosis of Acute Myeloid Leukaemia or High-risk MDS according to IPSS •Patient eligible for AML-like induction therapy •Candidate for multiple–days chemotherapy (minimum 3 days) •Age > 18 years •ECOG 0-2 •Not pregnant or nursing •Must be able to complete the patient’s diary •Provide written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14
排除标准
- •AML or HR-MDS therapy-related •Active infection requiring intravenous antibiotics •Prior malignancies at other sites except surgically treated non-melanoma skin cancer, prostate cancer, superficial cervical cancer, or other cancer from which the patient had been disease-free for = 5 years •Unacceptable hepatic function (>2 times the upper limit of normal for liver transaminases) and renal function (creatinine >1.5 times the upper limit of normal) unless disease-related •Myocardial infarction within the past 6 months •Psychiatric or CNS disorders interfering with ability to comply with study protocol •Known hypersensitivity to 5-HT3 antagonists and their components •CSF involvement •Pre-existing nausea or vomiting - treatment with experimental drug within the last month - Uncontrolled diabetes
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