CompletedPhase 2

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

France, Germany35 participantsStarted 2008-08

Plain-language summary

To assess the tolerability and effectiveness of rabbit antithymocyte globulin (ATG, Thymoglobuline) with ciclosporin in the first line treatment of patients with acquired severe aplastic anaemia, and patients with non-severe aplastic anaemia and who are transfusion dependent.

Who can participate

Age range16 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Must fulfil definition of aplastic anaemia:
✓. 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

What they're measuring

Number of Participants With Response to Rabbit Antithymocyte Globulin (Thymoglobuline)

Timeframe: at 6months

Trial details

NCT IDNCT00471848

SponsorEuropean Society for Blood and Marrow Transplantation

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2011-10

Results submitted2020-12-21

View on ClinicalTrials.gov More Aplastic Anemia trials