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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

Summary

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.

Description

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

Conditions

Aplastic Anaemia

Intervention

G-CSF, Early retreatment with ATG

Location

St. Louis Hospital
Paris
France
Sw17 0RE

Status

Terminated

Source

European Group for Blood and Marrow Transplantation

Results (where available)

View Results

Links

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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Action taken to reduce susceptibility or exposure to health problems and to detect and treat disease in early stages.

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