Prospective Phase II Pilot study of Rabbit Antithymocyte globulin(ATG, Thymoglobuline®, Genzyme) with Ciclosporin for Patients withAcquired Aplastic Anaemia and comparison with matched historicalpatients treated with horse ATG and Ciclosporin: a Study from theEuropean Blood and Marrow Transplant (EBMT) Severe AplasticAnaemia Working Party

Conditions: Acquired severe aplastic anaemia and transfusion dependent non-severe aplastic anaemia
MedDRA version: 12.0Level: LLTClassification code 10002969Term: Aplastic anemia

Registration Number: EUCTR2007-000902-55-DE

Lead Sponsor: EBMT (European Group for Blood and Marrow Transplantation)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 35

Inclusion Criteria

1) 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
1.1) SAA as defined by a hypocellular bone marrow of <25% cellularity and 2 of the following 3 peripheral blood criteria: neutrophil count < 0.5 x 109/l, platelets < 20 x 109/l and/or reticulocytes < 20 x 109/l
1.2) NSAA as defined by a hypocellular bone marrow and cytopenia in at least two cell lines AND neutrophil count > 0.5 x 109/l, and red cell and/or platelet transfusion dependence
1.3) Acquired AA
2) Time from diagnosis to study registration = 6mths
3) No prior treatment except for haemopoietic growth factors given for no more than 4 weeks, or prior treatment with androgens.
4) Age = 16yrs (= 18yrs in Germany and Switzerland), with no upper age limit.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Eligibility for an HLA-matched sibling donor transplant for SAA patients
2) Prior therapy with ATG or CSA
3) Haematopoeitic growth factors more than 4 weeks before study enrollment
4) Diagnosis of Fanconi anaemia, dyskeratosis congenita or congenital bone mar¬row failure syndrome
5) Evidence of myelodysplastic disease
6) Paroxysmal nocturnal haemoglobinuria with evidence of significant haemolysis, history of PNH associated thrombosis or a PNH clone > 50% by flow cytometry
7) Diagnosis or previous history of carcinoma (except local cervical, basal cell, squamous cells, or melanoma)
8) Subject is pregnant (e.g. positive HCG test) or is breast feeding
9) Severe uncontrolled infection or unexplained fever > 38oC
10) Subjects who have hepatic, renal cardiac, metabolic or other concur¬rent diseases of such severity that life expectancy is less than 3 months