ACTRN12619000248167终止2 期
AMLM22/D1: 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 patients with acute myeloid leukaemia in first complete remission.
Australian Leukaemia and Lymphoma Group (ALLG)0 个研究点目标入组 5 人开始时间: 2019年2月19日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
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%
- •1. Meets inclusion criteria outlined in IAPC master protocol. (the above)
- •2. Platelet count =100 x109/L and neutrophil count =0.5 x 109/
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
- •AMLM22/D1 specific exclusion criteria:
- •1. Presence of any general exclusion criteria outlined in in IAPC master protocol.
- •2. Prior solid organ transplant.
- •3. Cardiac abnormalities as evidenced by any of the following:
- •a. Clinically significant conduction abnormalities or uncontrolled arrhythmia.
- •b. Greater than or equal to New York Heart Association (NYHA) class II congestive cardiac failure and/or ejection fraction < 50% by echocardiogram (ECHO) or multi gated acquisition scan (MUGA)
- •c. Unstable angina or myocardial infarction with coronary angioplasty/stenting within the last 3 months
- •d. ECG findings demonstrating baseline a QTcF interval greater than or equal to 480 ms
- •4. Increased bleeding risk as a result of:
- •a. Use of anticoagulants at therapeutic levels within 7 days prior to the first dose of Molibresib (GSK525762).
- •b. Evidence of active bleeding or major bleed within the last 3 months.
- •c. Coagulation parameters (prothrombin time/international normalised ratio [PT/INR] and activated partial thromboplastin time [APTT]) greater than or equal to 1.2 x upper limit of normal (ULN)
- •5. Subject not able to comply with domain-specific contraception recommendations
研究者
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