EUCTR2006-003189-33-IT进行中（未招募）不适用
Phase II study with Palonosetron alone in preventing chemotherapy-induced nausea and vomiting in untreated patients with aggressive Non Hodgkin?s Lymphomas who underwent moderately emetogenic chemotherapy - Palonosetron in NH
G.I.S.L. - GRUPPO ITALIANO STUDIO LINFOMI0 个研究点开始时间: 2009年5月26日最近更新:
适应症
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
- •·Male or female, ³ 18 years of age;
- •·Histologically or cytologically confirmed aggressive NHL (any stage in accordance with the REAL Classification);
- •·Patients candidates to a initial chemotherapy treatment;
- •·ECOG performance status of 0-1;
- •·Scheduled to receive a single intravenous dose of at least one of the moderately emetogenic agents (according to the modified Hesketh classification reported in the Appendix 2) on Day 1;
- •·Written informed consent;
- •·Female of childbearing potential must be using reliable contraceptive measures;
- •·Acceptable hepatic function (£2 times the upper limit of normal for liver transaminases) and renal function (creatinine <1.5 times the upper limit of normal);
- •·Willing and able to complete the patient diary.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •·Highly emetogenic chemotherapy (containing cisplatin, mechloretamine, streptozotocin, cyclophosphamide ³1500 mg/sqm; carmustine; dacarbazine; hexamethylmelamine; procarbazine), or single-agent chemotherapy with drugs having low/minimal emetogenic potential according to the Hesketh classification reported in the Appendix 3);
- •·Diagnosis of Hodgkin?s Disease or Leukemia;
- •·Candidates to High-Dose Chemotherapy or Bone Marrow/Peripheral Blood Stem Cells Transplantation;
- •·Chemotherapy schedules considering the administration of emetogenic drugs in more than two consecutive days;
- •·Have received any investigational drugs within 30 days before study entry;
- •·Have received any drug with potential anti-emetic efficacy (with the exception of specific corticosteroids foreseen in the chemotherapy combination) within 24 hours of treatment initiation);
- •·Prior treatment with Palonosetron;
- •·Have a seizure disorder requiring anticonvulsant medication unless clinically stable and free of seizure activity;
- •·Experienced or ongoing vomiting or nausea from any organic etiology, in the screening phase;
- •·Clinical evidence of current or impending bowel obstruction, peritonitis, infection, uremia, severe mucositis;
- •·Clinically relevant electrolyte abnormalities;
- •·Have a known hypersensitivity to 5HT3 receptor antagonists;
- •·Radiotherapy within 30 days before chemotherapy administration, or scheduled to receive radiotherapy within two weeks after chemotherapy;
- •·Female patients who are pregnant or breast feeding;
- •·Inability to understand or cooperate with the study procedures.
研究者
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