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Randomized Study In Severe Aplastic Anemia Patients Receiving Atg, Cyclosporin A, With Or Without G-CSF (SAA-G-CSF)
Randomized Study In Severe Aplastic Anemia Patients Receiving Atg, Cyclosporin A, With Or Without G-CSF (SAA-G-CSF)

NCT01163942

TerminatedPhase 3

Sponsor: European Society for Blood and Marrow Transplantation

Conditions: Aplastic Anaemia

Interventions: G-CSF, Early retreatment with ATG

Countries: Czechia, France, Germany, Greece, Italy, Netherlands, Sweden, Switzerland

The purpose of this study is to examine the effect of G-CSF on disease free survival and overall survival in aplastic anaemia patients who also receive ATG and Cyclosporin A.

Eligibility overview

Sex: ALL

Age: 2 Years to 90 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Severe or very severe aplastic anemia
* Less than 6 months from diagnosis of severe aplastic anemia by bone marrow biopsy
* Ethical - Before randomization is done the subject or legally acceptable representative must give written informed consent for participation in the study

Exclusion Criteria:

* Eligibility for an HLA-matched sibling donor transplant
* Prior therapy with ATG
* Cyclosporin A \<4 weeks before enrollment
* Treatment with G-CSF \<2 weeks before enrollment
* Other growth factors \<4 weeks before enrollment
* Diagnosis of Fanconi anemia, dyskeratosis congenita or congenital bone marrow failure syndrome
* Evidence of myelodysplastic disease
* Diagnosis or previous history of carcinoma (except local cervical, basal cell, squamous cells, or melanoma)
* Subjects who have infection, hepatic, renal cardiac, metabolic or other concurrent diseases of such severity that death is imminent
* Subject is pregnant (e.g. positive HCG test) or is breast feeding
Locations (71)
  • Pilsen, Czechia
  • Angers, France
  • Bobigny, France
  • Brest, France
  • Caen, France
  • Caen, France
  • Créteil, France
  • Limoges, France
  • Marseille, France
  • Montpellier, France
  • Nîmes, France
  • Paris, France
  • Paris, France
  • Reims, France
  • Toulouse, France
  • Tours, France
  • Villejuf, France
  • Berlin, Germany
  • Berlin, Germany
  • Berlin, Germany
  • Bremen, Germany
  • Cologne, Germany
  • Dresden, Germany
  • Duisburg, Germany
  • Düsseldorf, Germany
  • Essen, Germany
  • Frankfurt, Germany
  • Göttingen, Germany
  • Hagen, Germany
  • Halle, Germany
  • + 41 more on CT.gov