NCT01163942

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: European Society for Blood and Marrow Transplantation · Network
• Sex: All
• Age: 2 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Aplastic Anaemia

Interventions

Type	Name	Description
DRUG	G-CSF	Yes/no addition of G-CSF
DRUG	Early retreatment with ATG	Yes/no early retreatment with ATG

Timeline

• Start date: 2001-03-01
• Primary completion: 2008-06-01
• Completion: 2010-11-01
• First posted: 2010-07-16
• Last updated: 2024-02-20

Locations

71 sites across 9 countries: Czechia, France, Germany, Greece, Italy, Netherlands, Sweden, Switzerland, United Kingdom