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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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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.
A form of anemia in which the bone marrow fails to produce adequate numbers of peripheral blood elements.
Methods to determine in patients the nature of a disease or disorder at its early stage of progression. Generally, early diagnosis improves PROGNOSIS and TREATMENT OUTCOME.
Action taken to reduce susceptibility or exposure to health problems and to detect and treat disease in early stages.
Methods to identify and characterize cancer in the early stages of disease and predict tumor behavior.
Organ transplantation is the moving of an organ from one body to another or from a donor site to another location on the patient's own body, for the purpose of replacing the recipient's damaged or absent organ. The emerging field of regenerative ...