EUCTR2007-007091-41-IT进行中（未招募）不适用
Phase II Trial of the Histone-Deacetylase Inhibitor ITF2357 Followed by Mechlorethamine in Relapsed/Refractory Hodgkin?s Lymphoma Patients - ND
ITALFARMACO0 个研究点开始时间: 2008年5月21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
- •Written Informed Consent.
- •Age ≥18 years.
- •Histologically confirmed diagnosis of Hodgkin?s lymphoma.
- •Subjects who have failed second-line or subsequent-line salvage chemo-radiotherapy regimens for whom no other treatment options of proven efficacy can be given.
- •Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements
- •-ANC ≥1500/µL; Platelet count ≥75000/µL
- •-Hemoglobin ≥9 g/dL (may not be transfused or treated with erythropoietin to maintain or exceed this level)
- •-Total bilirubin ≤1.6 mg/dL; AST or ALT ≤2.5 times the upper limit of normal
- •-Serum creatinine ≤2.0 mg/dL or creatinine clearance >50 mL/min
- •-Serum Potassium and Magnesium within normal limits
- •Subjects with at least one bi-dimensional lesion measurable by CT-scan or MRI, according to the Revised Response Criteria for Malignant Lymphoma of the International Working Group (J Clin Oncol, 25:579-586, 2007).
- •ECOG performance status of 0 or 1
- •Use of an effective means of contraception for women of childbearing potential and men with partners of childbearing potential
- •Life expectancy of >3 months
- •Subjects receiving intravenous Mechlorethamine (6 mg/sqm) as single agent at least 4 weeks before study entry
- •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
- •Active bacterial or mycotic infection requiring antimicrobial treatment
- •Pregnancy or lactation
- •Anticancer chemotherapy or radiotherapy during the study or within 4 weeks of study entry.
- •A marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration of a QTc interval > 450 ms, according to Bazett?s correction formula ? see appendix I for the formula)
- •Use of concomitant medications that prolong the QT/QTc interval (see appendix H for full list)
- •Clinically significant cardiovascular disease including:
- •-Uncontrolled hypertension, myocardial infarction, unstable angina
- •-New York Heart Association (NYHA) Grade II or greater congestive heart failure
- •-History of any cardiac arrhythmia requiring medication (irrespective of its severity)
- •-A history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- •Positive blood test for HIV, HBV and HCV
- •Identification of viral DNA by quantitative PCR for EBV and JC virus.
研究者
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