CompletedPhase 2

Prospective Phase II Study of Rabbit Antithymocyte Globulin (ATG, Thymoglobuline®, Genzyme) With Ciclosporin for Patients With Acquired Aplastic Anaemia

35 participantsStarted 2008-04

Plain-language summary

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).

Who can participate

Age range16 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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

What they're measuring

Response

Timeframe: 2 years

Trial details

NCT IDNCT01530555

SponsorKing Faisal Specialist Hospital & Research Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-07

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