ACTRN12621001713886招募中1 期
MDS05/D1: (MYDAS-T) Assessing the safety of ES-3000 and ASTX727 in patients with myelodysplasia
Australasian Leukaemia and Lymphoma Group0 个研究点目标入组 32 人开始时间: 2021年12月15日最近更新:
适应症
试验速览
- 阶段
- 1 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
- 16 Years 至 o limit（—）
- 性别
- All
入选标准
- •Eligibility criteria are noted in the MDS05 Master Protocol as below:
- •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 authorising HREC)
- •4. A diagnosis of MDS or AML with < 30% blasts
- •5. Any other inclusion criteria mentioned in the study domain e.g., older AML patients (> 30% blasts) who are not suitable for intensive arms of AML trials or treatment may be suitable for certain domains of the MDS trials. This will be specified in the domain inclusion criteria.
- •The following point must also be met to be eligible for participation in this domain:
- •1. All previously treatment naïve myelodysplasia patients with IPSS score >= 1.5 and be eligible for standard AZA treatment in Australia. AML with blasts <30% (in peripheral blood and bone marrow) will also be eligible for this study.
排除标准
- •Exclusion criteria as in the Master protocol will apply as below:
- •1. History of other malignancy requiring active systemic treatment, or which is likely to result in an expected survival time of < 12 months.
- •2. Viral infection with known HIV or viral hepatitis type B or C not adequately controlled by antiviral medication.
- •3. Prior bone marrow or stem cell transplantation for a diagnosis of Myelodysplasia or acute myeloid leukaemia. If stem cell transplantation has been undertaken for other reasons- refer to individual domain and discuss with study team.
- •In addition, the following patients will be excluded:
- •1. Patients with QTcF> 480msecs (females) and QTcF> 450msecs (males) will be excluded from this study
- •2. Subjects who has received allogeneic HSCT or solid organ transplantation.
- •3. Subject has a history of an active malignancy within the past 2 years prior to study entry, with the exception of:
- •a. Adequately treated in situ carcinoma of the cervix uteri
- •b. Adequately treated basal cell carcinoma or localized squamous cell carcinoma
- •of the skin
- •c. Asymptomatic prostate cancer without known metastatic disease and with no
- •requirement for therapy
- •4. Subject has a known positive test for human immunodeficiency virus (HIV). Note: HIV testing is not required at Screening.
- •5. Subject has chronic active hepatitis B (HBV) or hepatitis C (HCV) requiring treatment.
- •6. Subject exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to ongoing systemic infection (viral, bacterial, or fungal).
- •7. Subject has a malabsorption syndrome or other condition that precludes an enteral route of administration.
- •8. Subject has history of a significant cardiovascular, endocrine, hepatic, immunologic metabolic, neurologic, psychiatric, pulmonary, renal disease, or any other condition that in the opinion of the investigator would adversely affect his/her participation in this study or interpretation of study results. Note: For subjects who have required an intervention for any above diseases within the past 6 months requires a discussion between the investigator and study team.
- •9. Subject is concurrently participating in another therapeutic clinical trial.
- •10. Subject is pregnant or breastfeeding.
研究者
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