ACTRN12619001042134进行中（未招募）2 期
Avatrombopag plus up Front ImmunosuppReSsive Therapy in treatment-naive severe aplastic anaemia (AA) – a Bayesian Optimal Phase II study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 57
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
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Severe or very severe aplastic anaemia characterised by bone marrow cellularity <30% (excluding lymphocytes) and at least two of the following:
- •a.Absolute neutrophil count <0.5 x10^9/L
- •b.Platelet count <20 x 10^9/L
- •c.Absolute reticulocyte count <60 x 10^9/L
- •2.No prior ATG-based immunosuppressive therapy
- •3.Age >18 years
- •4.Negative pregnancy test for women of child bearing potential
排除标准
- •1.Planned for a sibling allogeneic stem cell transplant
- •2.Evidence of a myelodysplastic syndrome, defined according to the World Health Organization 2017 criteria. Patients with AA with cytogenetic abnormalities that are recurrent in MDS, who do not meet the WHO diagnostic criteria for MDS, are also excluded. Patients with del(20q), +8 and –Y are not included in this category and are therefore eligible for this trial.
- •3.Known diagnosis or clinical suspicion of inherited bone marrow failure syndrome (IBMFS), including but not limited to Fanconi Anaemia, Dyskeratosis Congenita, Shwachman-Diamond Syndrome and Diamond-Blackfan Anaemia
- •4.Previous history of stem cell transplantation
- •5.Cancer diagnosis within the last 5 years (except for patients with resected basal cell carcinoma or squamous cell carcinoma of the skin)
- •6.Previous history of melanoma
- •7.Pregnant or breast feeding patients2,3
- •8.Active CMV disease
- •9.Participants with known hypersensitivity to any of the component medications (avatrombopag, cyclosporine, horse or rabbit ATG)
- •10.Concurrent hepatic, renal or cardiac disease of such severity that it would in the investigator’s opinion, preclude the patient’s ability to tolerate protocol therapy
- •11.Death anticipated within 14 days
研究者
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