ACTRN12621000246886尚未招募2 期
AMLM22/D3-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 3 is investigating the safety and efficacy of an Astrazeneca drug labelled AZD5153 as a maintenance therapy option.
Australian Leukaemia and Lymphoma Group (ALLG)0 个研究点目标入组 50 人开始时间: 2021年3月8日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
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%
排除标准
- •1.Chemotherapy or investigational agents within 28 days of planned study cycle 1 day 1
- •2.History of other malignancy requiring active systemic treatment or which is likely to result in an expected survival time of less than 2 years
- •3.Viral infection with known HIV or viral hepatitis type B or C not adequately controlled by antiviral medication
- •4.Prior bone marrow or stem cell transplantation
- •AMLM22/D3 specific exclusion criteria:
- •1.Presence of any general exclusion criteria outlined in in IAPC master protocol.
- •2.Platelet count greater than or equal to 100 x 10^9 /L
- •3.Increased bleeding risk as a result of:
- •a.Use of parenteral anticoagulants at therapeutic levels, warfarin or direct oral anticoagulants within 14 days prior to the first dose of AZD5153.
- •b.Coagulation parameters (prothrombin time/international normalised ratio [PT/INR] and activated partial thromboplastin time [APTT]) less than or equal to 1.5 x upper limit of normal (ULN)
- •4.Cardiac abnormalities as evidenced by any of the following:
- •a.Clinically significant conduction abnormalities or uncontrolled arrhythmia.
- •b.Uncontrolled hypertension
- •c.Greater than or equal to New York Heart Association (NYHA) class II congestive cardiac failure and/or left ventricular ejection fraction < 50% by echocardiogram (ECHO) or multi gated acquisition scan (MUGA)
- •d.ECG findings demonstrating baseline a QTcF interval greater than or equal to 450 ms
- •5.Subject not able to comply with domain-specific contraception recommendations below:
- •a.Female patients must use two highly effective contraceptive measures. All methods of contraception (with the exception of total abstinence) should be used in combination with the use of a condom by a male sexual partner for intercourse.
- •b.Female patients must not be breast-feeding and must have a negative pregnancy test prior to start of dosing if of childbearing potential or must have evidence of non-childbearing potential by fulfilling one of the following criteria at screening:
- •i.Post-menopausal women defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatment.
- •ii.Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, but not tubal ligation.
研究者
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