ACTRN12619000280101招募中2 期
AMLM22/D2-The International Acute myeloid leukaemia (AML) Platform Consortium (IAPC) trial is a randomised, multi-arm study platform to compare the efficacy of experimental therapies versus standard of care in subjects with acute myeloid leukaemia in first complete remission. Domain 2 is investigating the safety and efficacy of Venetoclax as a maintenance therapy alone or in combination with low dose cytarabine (LDAC).
Australian Leukaemia and Lymphoma Group (ALLG)0 个研究点目标入组 75 人开始时间: 2019年2月25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
- 75
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 16 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Provision of written informed consent
- •2. Provision of written informed consent to the ALLG NBCR
- •3. Age 18+ (Age 16-17 permitted if consent for minor PICF approved by the authorizing HREC)
- •4. AML (excluding APL) in first complete remission with bone marrow blasts <5%
- •5. Subject has achieved remission after intensive chemotherapy (e.g. 7+3 or equivalent +/- subsequent consolidation therapy)
- •6. ECOG 0-2
- •7. Subject must have adequate renal function as demonstrated by a creatinine clearance greater than or equal to 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24-hours urine collection
- •8. Subject must have adequate liver function as demonstrated by:
- •a.aspartate aminotransferase (AST) greater than or equal to 3.0 × ULN
- •b.alanine aminotransferase (ALT) greater than or equal to 3.0 × ULN
- •c.bilirubin greater than or equal to 1.5 × ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)
- •9. Agrees to follow the recommended contraception procedures for this treatment domain
排除标准
- •1. Chemotherapy or investigational agents within 28 days of planned study cycle 1 day
- •2. Impaired hematologic recovery 8 weeks after last chemotherapy
- •a. Grade 2 anemia (Hb <100g/L)
- •b. Grade 4 neutropenia (N <0.5 x 109/L)
- •c. Grade 3 thrombocyotopenia (Plt <50 x 109/L)
- •3. History of other malignancy requiring active systemic treatment or which is likely to result in an expected survival time of < 2 years
- •4. Viral infection with known HIV or viral hepatitis type B or C not adequately controlled by antiviral medication
- •5. Prior bone marrow or stem cell transplantation
- •6. There is an intent to undertake a stem cell transplant procedure within the next 3 months
- •7. Subject is HIV positive
- •8. 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.
- •9. 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 inducers
- •c.Moderate or strong cytochrome CYP3A inhibitors may be used with caution with appropriate dose modifications for venetoclax
- •10. 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
- •11. Subject not able to comply with domain-specific contraception recommendations
研究者
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