EUCTR2008-007827-14-IT进行中（未招募）不适用
Multicenter, Phase IV, Open-Label, Uncontrolled Study to Assess the Efficacy and Safety of a Single Intravenous Dose of Palonosetron 0.25 mg (Aloxi, Onicit, Paloxi) in the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients with Non-Hodgkin s Lymphomas Undergoing Repeated Cycles of Moderately Emetogenic Chemotherapy - PALO-08-09
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
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
- •To be included in this study, or to continue participating in any of the repeated study cycles, the patients must meet the following criteria: 1. Male or female ≥18 years of age 2. Histologically or cytologically confirmed Non-Hodgkins Lymphoma 3. Patient scheduled to receive single-day MEC as one of the following regimens (at each study cycle) in at least two repeated and consecutive chemotherapy cycles: CHOP or R-CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone, with or without Rituximab) ProMACE-CytaBOM (cyclophosphamide, doxorubicin, etoposide, cytarabine, bleomycin, vincristine, methotrexate, leucovorin and prednisone) Note: Consecutive chemotherapeutic cycles must employ the same chemotherapeutic regimen. This can include changes in dose (adjustments of dose) of the MEC agent(s) or discontinuation of low, minimal or non-emetogenic concomitant chemotherapeutic agents as clinically appropriate, with no highly emetogenic agents added. 4. Na?ve to cancer chemotherapy (i.e. the patient has no chemotherapeutic history) 5. A Karnofsky Performance Status of ≥ 50%, at each study cycle 6. Signed written informed consent (with additional legal representatives consent or parents consent if required) 7. Patient with a known hepatic, renal or cardiovascular impairment, including cardiac conduction interval abnormalities, and scheduled to receive the above mentioned chemotherapeutic agents, may be enrolled in this study or continue the participation in each of the repeated study cycles at the discretion of the Investigator 8. Female patient of childbearing potential must be using reliable contraceptive measures with a negative urine pregnancy test before any study treatment administration
- •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
- •Patients are excluded from the enrollment in this study or from the participation in any of the subsequent repeated study cycles if they meet any of the following criteria: 1. Inability to understand or co-operate with the study procedures, at any study cycle 2. Any investigational drugs (other than those given in this study) administered within 30 days before intake of study medication, at each study cycle 3. Any drug with potential anti-emetic efficacy administered within 24 hours of the intake of study medication, at each study cycle. Examples of these drugs are listed in the protocol Appendix E. Patients taking topical or inhaled steroids may be enrolled in the study 4. Any vomiting, retching, or NCI Common Toxicity Criteria Grade 2 or 3 nausea in the 24 hours preceding chemotherapy, at each study cycle 5. Treatment with commercial palonosetron (Aloxi?, Onicit? and Paloxi?) within 2 weeks prior to the intake of study treatment, at each study cycle 6. Enrollment in a previous study with palonosetron 7. Ongoing vomiting from any organic etiology, at each study cycle 8. Presence of a clinically unstable seizure disorder with seizure activity requiring anticonvulsant medication (prophylactic anticonvulsant medication for patients free of seizure activity is allowed), at each study cycle 9. IV Palonosetron 0.25 mg not administered in consecutive MEC cycles (see Section 7.1) 10. Patient with AIDS-related B-cell Lymphoma 11. Patient testing positive to the HBsAg test at the Screening Visit. 12. Scheduled to receive: Moderately emetogenic chemotherapy between the Screening Visit and the first study medication administration, on Days 2 to 5 of each study cycle, or on any day between two consecutive study cycles Highly emetogenic chemotherapy, orally or intravenously: any dose of cisplatin, dacarbazine, streptozotocin, carmustine, mechlorethamine, hexamethylmelamine or procarbazine; or cyclophosphamide ≥1500 mg/m2 between the Screening Visit and the first study medication administration or during the study Radiotherapy of upper abdomen or cranium or total body irradiation within 7 days prior to the first study medication administration or during the study Any low-level emetogenic chemotherapeutic agent during Days 2 to 5 of each study cycle, if this chemotherapy, in the Investigators opinion, requires co-administration of additional anti-emetics. Administration of low-level emetogenic chemotherapy without additional anti-emetics is allowed on Days 2 to 5 13. Known contraindication to 5-HT3 receptor antagonists, at each study cycle
研究者
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