EUCTR2007-004480-21-IT进行中（未招募）不适用
A phase IIA study of the histone-deacetylase inhibitor ITF2357 in patients with JAK-2 V617F positive chronic myeloproliferative diseases - ND
ITALFARMACO0 个研究点开始时间: 2008年1月10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
- •Signed Informed Consent Form
- •Male or female, age ≥ 18 years
- •Confirmed diagnosis of PV/ET/MF according to the revised WHO criteria
- •JAK-2 V617F positivity
- •In need of cytoreductive therapy when hydroxyurea is not indicated (e.g. young patients) or when refractoriness to the drug is documented
- •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 fungal infection requiring antimicrobial treatment on Day 1
- •Patients of childbearing potential without a negative pregnancy test prior to initiation of the study drug
- •Pregnancy or lactation
- •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 G for the formula)
- •The use of concomitant medications that prolong the QT/QTc interval (see appendix F for full list)
- •Concomitant acute coronary syndromes; uncontrolled hypertension
- •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)
- •Active EBV infection (i.e. positive serology IgM)
- •Known HIV infection
- •Active hepatitis B and/or C infection
- •History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk from treatment complications
- •ECOG performance status 3 or greater
- •Platelets count <100x109/L within 14 days before enrolment
- •Absolute neutrophil count <1.2x109/L within 14 days before enrolment
- •Percentage of blast cells in peripheral blood >10% within 14 days before enrolment
- •Serum creatinine >2xULN
- •Total serum bilirubin >1.5xULN
- •Serum AST/ALT > 3xULN
- •Interferon alpha within 14 days before enrolment
- •Hydroxyurea within 14 days before enrolment
- •Anagrelide within 7 days before enrolment
- •Any other investigational drug within 28 days before enrolment
研究者
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