Rabbit Antithymocyte Globulin (Thymoglobuline) With Ciclosporin for Patients With Acquired Aplastic Anaemia

Inclusion Criteria

• Must fulfil definition of aplastic anaemia:

There must be at least two of the following:

• haemoglobin 0.5 x 109/l, and red cell and/or platelet transfusion dependence
• Have acquired aplastic anaemia
• Time from diagnosis to study registration maximum 6 months
• No prior treatment except for haemopoietic growth factors given for no more than four weeks, and androgens
• Age minimum 16 years with no upper age limit

Exclusion Criteria

• Eligibility for an human leukocyte antigens (HLA)-matched sibling donor transplant for SAA patients
• Prior therapy with ATG or CSA
• Haematopoeitic growth factors more than 4 weeks before study enrolment
• 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 Paroxysmal Nocturnal Hemoglobinuria (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 Human Chorionic Gonadotropin (HCG) test) or is breast feeding
• Severe uncontrolled infection or unexplained fever >38 degrees Celsius
• Subjects who have hepatic, renal cardiac, metabolic or other concurrent diseases of such severity that life expectancy is less than 3 months