ACTRN12619000746134招募中2 期
A phase 2 study of venetoclax in combination with low-dose cytarabine in relapsing acute myeloid leukemia
Alfred Hospital0 个研究点目标入组 32 人开始时间: 2019年5月20日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Relapsing AML
- •2.Received no more than 1 prior line of intensive chemotherapy for AML
- •a.Post-remission therapy incl. consolidation, maintenance or HSCT is considered 1 line of therapy
- •b.Prior hypomethylating agent is permitted
- •3.Age 18 years or older. No upper age limits.
- •4.ECOG performance status 0-2
- •5.Adequate organ function as defined by:
- •a.Creatinine clearance equal to or greater than 30 ml/min
- •b.Bilirubin less than or equal to 1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)
- •c.Aspartate transaminase (AST) and alanine transaminase (ALT) less than or equal to 3.0 x ULN
- •6.WCC <25 x 109/L (hydroxyurea or thioguanine are permitted to meet this criterion)
- •7.Males with a female partner of childbearing potential must agree to use at least 2 effective contraceptive methods throughout the study and for 30 days following the date of last dose
排除标准
- •1.Acute promyelocytic leukemia
- •2.Prior and concomitant therapy
- •a.Anticancer therapies including chemotherapy, radiotherapy, or other investigational therapy, including targeted small molecule agents: exclude 5 half-lives prior to first dose and throughout venetoclax administration
- •b.Biologic agents (e.g. monoclonal antibodies) for anti-neoplastic intent: exclude 30 days prior to first dose and throughout venetoclax administration
- •3.Prior exposure to Venetoclax or other BCL-2 inhibitors
- •4.Known contraindication of or allergy to allopurinol, xanthine oxidase inhibitors and rasburicase
- •5.History of malignancy with the exception of:
- •a.Adequately treated in situ carcinoma of the cervix uteri
- •b.Adequately treated non-melanoma skin cancer
- •c.Localized prostate cancer with no requirement for therapy
- •d.Prior cancer not requiring active therapy and with an expected survival greater than 2 years
- •6.Subject is known to be positive for HIV (HIV testing is not required)
- •7.Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
- •a.Uncontrolled and/or active systemic infection (viral, bacterial or fungal)
- •b.Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIg) may participate
- •8.Treatment with any of the following within 7 days prior to the first dose of study drug:
- •a.Steroid therapy for anti-neoplastic intent
- •b.Moderate or strong CYP3A inhibitors
- •c.Moderate or strong CYP3A inducers
- •9.Administration or consumption of any of the following within 3 days prior to the first dose of study drug:
- •a.Grapefruit or grapefruit products
- •b.Seville oranges (including marmalade containing Seville oranges)
- •c.Star fruit
- •10.Significant medical, psychiatric, or any other condition that in the opinion of the investigator would adversely affect subject’s participation in this study or interpretation of study results
研究者
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