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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.
Allocation: Randomized, Control: Placebo Control, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
G-CSF, Early retreatment with ATG
St. Louis Hospital
European Group for Blood and Marrow Transplantation
Published on BioPortfolio: 2014-08-27T03:12:10-0400
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