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

2014-08-27 03:12:10 | BioPortfolio


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.


Open label, randomized, controlled study of G-CSF, ATG and Cyclosporin A versus ATG and Cyclosporin A. Subjects will be evaluated for hematologic response through day 240. Subjects who do not demonstrate a partial or complete remission by day 120 will be randomized to receive either a second course of ATG or continue their current regimen. Subjects who do demonstrate a partial or complete remission will continue their current regimen through day 240 or maintenance of a complete remission for 30 days. The last day of study treatment will be day 240.

Study Design

Allocation: Randomized, Control: Placebo Control, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Aplastic Anaemia


G-CSF, Early retreatment with ATG


St. Louis Hospital
Sw17 0RE




European Group for Blood and Marrow Transplantation

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:12:10-0400

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Medical and Biotech [MESH] Definitions

The therapy of the same disease in a patient, with the same agent or procedure repeated after initial treatment, or with an additional or alternate measure or follow-up. It does not include therapy which requires more than one administration of a therapeutic agent or regimen. Retreatment is often used with reference to a different modality when the original one was inadequate, harmful, or unsuccessful.

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