NCT01530555已完成2 期
Prospective Phase II Study of Rabbit Antithymocyte Globulin (ATG, Thymoglobuline®, Genzyme) With Ciclosporin for Patients With Acquired Aplastic Anaemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 主要终点
- Response
研究概览
简要总结
To assess the tolerability and efficacy of rabbit antithymocyte globulin (ATG, Thymoglobuline®) with ciclosporin (CSA) in the first line treatment of patients with acquired severe aplastic anaemia (SAA), and patients with non-severe aplastic anaemia (NSAA) and who are transfusion dependent. To compare the response rate of the combination of rabbit ATG (Thymoglobuline® and CSA from this pilot study with the response rate observed in a series of matched AA patients; treated after 1994 with the combination of horse ATG (Lymphoglobuline®) and CSA; obtained from the EBMT database (comparative study).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To define aplastic anaemia there must be at least two of the following: (1) haemoglobin < 10g/dl; (2) platelet count < 50 x 109/l; (3) neutrophil count < 1.5 x 109/l, and a hypocellular bone marrow on bone marrow biopsy
- •Time from diagnosis to study registration ≤ 6mths
- •No prior treatment except for haemopoietic growth factors given for no more than 4 weeks, and androgens.
- •Age ≥ 16yrs (≥ 18yrs in Germany in accordance with German law), with no upper age limit.
- •Exclusion criteria:
- •Eligibility for an HLA-matched sibling donor transplant for SAA patients
- •Prior therapy with ATG or CSA
- •Haematopoeitic growth factors more than 4 weeks before study enrollment
- •Diagnosis of Fanconi anaemia, dyskeratosis congenita or congenital bone marrow failure syndrome
- •Evidence of myelodysplastic disease
- •Paroxysmal nocturnal haemoglobinuria with evidence of significant haemolysis, history of PNH associated thrombosis or a PNH clone > 50% by flow cytometry
- •Diagnosis or previous history of carcinoma (except local cervical, basal cell, squamous cells, or melanoma)
- •Subject is pregnant (e.g. positive HCG test) or is breast feeding
- •Severe uncontrolled infection or unexplained fever > 38oC
- •Subjects who have hepatic, renal cardiac, metabolic or other concurrent diseases of such severity that life expectancy is less than 3 months
排除标准
- 未提供
研究组 & 干预措施
Treatment arm
Experimental
- Rabbit ATG, Thymoglobuline (Genzyme) 1.5 vials/10kg (3.75mg/kg) daily for 5 days given as an intravenous infusion over 12-18 hours.
- Ciclosporin (CSA) 5mg/kg/day orally from day +1 for a minimum of 6 months, with later tailing according to individual patient response. Aim to maintain trough whole blood CSA levels between 150 and 250 ng/ml.
干预措施: Rabbit ATG, Thymoglobuline (Genzyme) (Drug)
结局指标
主要结局
Response
时间窗: 2 years
Primary outcome is response at 6 months post ATG treatment
次要结局
- Over all survival(2 years)
研究者
相似试验
已完成
2 期
Rabbit Antithymocyte Globulin (Thymoglobuline) With Ciclosporin for Patients With Acquired Aplastic AnaemiaAplastic AnemiaNCT00471848European Society for Blood and Marrow Transplantation35
已完成
不适用
Safety and Efficacy Study of Thymoglobulin Versus IL2 Receptor AntagonistsEnd Stage Renal DiseaseNCT00859131Medical University of South Carolina200
已完成
1 期
Antithymocyte Globulin and Sirolimus in Treating Patients With Relapsed Multiple MyelomaDrug/Agent Toxicity by Tissue/OrganMultiple Myeloma and Plasma Cell NeoplasmNCT00317798University of Rochester18
进行中（未招募）
1 期
Prospective Phase II study of Rabbit Antithymocyte globulin (ATG, Thymoglobuline®, Genzyme) with Ciclosporin for Patients with Acquired Aplastic Anaemia and comparison with matched historical patients treated with horse ATG and CiclosporiAcquired severe aplastic anaemia and transfusion dependent non-severe aplastic anaemiaMedDRA version: 14.0 Level: LLT Classification code 10002274 Term: Anemia aplastic System Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2007-000902-55-GBEBMT (European group for Blood and Marrow Transplantation)35
已完成
2 期
Antithymocyte Globulin and Cyclosporine to Treat MyelodysplasiaMyelodysplastic SyndromeNCT00005937Neal Young, M.D.42