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

Aplastic Anaemia Clinical Trial

Official title: A RANDOMIZED CONTROLLED STUDY IN NEWLY DIAGNOSED SEVERE APLASTIC ANEMIA PATIENTS RECEIVING ANTITHYMOCYTE GLOBULIN (ATG), CYCLOSPORIN A, WITH OR WITHOUT G-CSF

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Anemia
• Anemia, Aplastic
• Aplastic Anaemia

• NCT number: NCT01163942
• Study type: Interventional
• Source: European Society for Blood and Marrow Transplantation
• Status: Terminated
• Phase: Phase 3
• Start date: March 2001
• Completion date: November 2010