EUCTR2005-005321-63-IT进行中（未招募）不适用
Multicentre, open label, uncontrolled, pilot, phase II study of oral ITF2357 in subjects with acute myeloid leukemia refractory/resistant and/or not suitable for any alternative therapy - ND
ITALFARMACO0 个研究点开始时间: 2008年12月16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
- •Diagnosis of primary or secondary AML (any French-American-British [FAB] type with the exception of M3 subtype, acute promyelocytic leukemia), in patients who are, for whatever reason, not considered candidates for conventional intensive chemotherapy and for any alternative treatment and:
- •- have relapsed after conventional chemotherapy, or,
- •- have AML that is refractory to at least 1 cycle of chemotherapy, or
- •-untreated elderly patient (>60) not suitable for any alternative treatment.
- •Not a candidate for allogeneic bone marrow transplantation.
- •ECOG Performance score of 0-3
- •Adequate hepatic and renal function, as defined by serum transaminases <2.5x ULN, bilirubin <1.5x ULN and creatinine <1.5x ULN.
- •Age 18 years or greater.
- •Documentation of written informed consent to participate in the trial.
- •Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- •At least 3 weeks from prior chemotherapy or other investigational anticancer therapy with full recovery from prior toxicities.
- •Either men or women, accepting to practice effective contraception during the entire study period unless documentation of infertility exists.
- •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
- •Treatment with any investigational agent within 3 weeks prior to study therapy.
- •Major surgeries within 4 weeks from study start or not fully recovered from any previous surgical procedure.
- •Presence of any medical or psychiatric condition which may limit full compliance with the study or increase the risk associated with study participation or study drug administration, including but not limited to:
- •Presence of central nervous system (CNS) leukemia.
- •Active uncontrolled bacterial infection.
- •Known human immunodeficiency virus (HIV) infection.
- •Significant cardiovascular disease (i.e., uncontrolled arrhythmias, unstable angina), or a major thromboembolic event (myocardial infarction, stroke, transient ischemic attack, pulmonary embolism, or non-catheter-related deep-vein thrombosis) in the last 6 months.
- •Pregnancy or breast-feeding.
- •Malabsorption syndromes
研究者
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