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

• Status: Terminated
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Group for Blood and Marrow Transplantation; European Society for Blood and Marrow Transplantation
• Collaborator: CHUGAI sanofi-aventis
• Treatments: Cyclosporine; Cyclosporins; Lenograstim

Criteria

Inclusion Criteria:

• Severe or very severe aplastic anemia

• Less than 6 months from diagnosis of severe aplastic anemia by bone marrow biopsy

• Ethical - Before randomization is done the subject or legally acceptable representative must give written informed consent for participation in the study

Exclusion Criteria:

• Eligibility for an HLA-matched sibling donor transplant

• Prior therapy with ATG

• Cyclosporin A <4 weeks before enrollment

• Treatment with G-CSF <2 weeks before enrollment

• Other growth factors <4 weeks before enrollment

• Diagnosis of Fanconi anemia, dyskeratosis congenita or congenital bone marrow failure syndrome

• Evidence of myelodysplastic disease

• Diagnosis or previous history of carcinoma (except local cervical, basal cell, squamous cells, or melanoma)

• Subjects who have infection, hepatic, renal cardiac, metabolic or other concurrent diseases of such severity that death is imminent

• Subject is pregnant (e.g. positive HCG test) or is breast feeding