NCT06525948尚未招募4 期
Efficacy and Safety of rhTPO in Combination With Cyclosporine Versus Cyclosporine Alone in the Treatment of Transfusion-dependent Non-severe Aplastic Anaemia (TD-NSAA)
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
Investigating the efficacy and safety of rhTPO in combination with cyclosporine versus cyclosporine alone for the treatment of TD-NSAA
详细描述
Investigating the efficacy and safety of rhTPO in combination with cyclosporine versus cyclosporine alone for the treatment of transfusion-dependent aplastic anaemia of the non-severe type
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged ≥ 18 years, male and female;
- •patients with a clear diagnosis of NSAA who are dependent on transfusion therapy:
- •Meet the Camitta NSAA criteria;
- •accompanied by at least one of the following abnormalities: (1) dependence on component blood transfusion therapy, at least one component blood transfusion every 8 weeks on average, and the duration of transfusion dependence ≥ 4 months, the indication of component blood transfusion: HGB ≤ 60g / L; (2) PLT ≤ 10 × 10 ^ 9 / L, or PLT ≤ 30 × 10 ^ 9 / L with a significant tendency to bleed; (3) neutrophils ≤ 0.5 × 10 ^ 9 / L.
- •Excluding other haematological and non-haematological diseases that cause pancytopenia;
- •ECOG PS score 0-2, expected survival ≥ 3 months with follow-up;
- •functional levels of major organs must meet the following requirements: 1) Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); 2) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN; 3) blood creatinine (Cr) ≤ 1.5 x ULN;
- •has not been treated with platelet receptor agonist (TPO-RA) analogues and other immunosuppressant analogues;
- •the subject is not suitable or willing to receive haematopoietic stem cell transplantation therapy;
- •no history of serious heart, lung, liver, kidney and other important organs and endocrine system diseases;
- •Voluntarily enroll in the study, sign the informed consent, have good compliance and willing to cooperate with the follow-up.
排除标准
- •have used other clinical investigational drugs within 4 weeks;
- •a history of primary myelodysplastic syndromes (MDS), primary paroxysmal sleep haemoglobinuria (PNH) and leukaemia, as well as congenital bone marrow failure syndromes (IBMFS), such as Fanconi's anaemia (FA) and congenital dyskeratosis (DC)
- •history of cirrhosis or history of portal hypertension;
- •congestive heart failure, arrhythmia, peripheral arteriovenous thrombosis requiring medication within 1 year prior to enrolment, or myocardial infarction or cerebral infarction within 3 months prior to enrolment;
- •HIV infection;
- •severe autoimmune disease or immunodeficiency disease;
- •suffering from malignant tumour
- •severe mental disorders;
- •a known history of allergy to the drug components of this regimen;
- •in the opinion of the investigator, it is not appropriate to participate in this trial, e.g., any other medical, social or psychological factors that may affect safety or compliance with the study procedures.
- •Compliance with study procedures.
研究组 & 干预措施
two-drug combination group
Experimental
rhTPO combined with cyclosporine
干预措施: rhTPO (Drug)
two-drug combination group
Experimental
rhTPO combined with cyclosporine
干预措施: Cyclosporin A (Drug)
drug-free group
Active Comparator
cyclosporine alone
干预措施: Cyclosporin A (Drug)
结局指标
主要结局
ORR
时间窗: 3 months
Overall Response Rate (ORR): meets the criteria for CR and PR.
CRR
时间窗: 3 months
Complete Response Rate (CRR)：ANC\>1.5×10\^9/L，Hb\>100g/L，PLT\>100×10\^9/L；
次要结局
- ORR(6 months)
- CRR(6 months)
- Time for platelet count to recover to ≥20 x 10^9/L with a 1-fold increase in absolute value(through study completion, an average of 1 year)
- Proportion of patients with adverse events(through study completion, an average of 1 year)
研究者
Bing Han
chief physician
Peking Union Medical College Hospital
研究点 (1)
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