Status:
TERMINATED
Randomized Study In Severe Aplastic Anemia Patients Receiving Atg, Cyclosporin A, With Or Without G-CSF (SAA-G-CSF)
Lead Sponsor:
European Society for Blood and Marrow Transplantation
Collaborating Sponsors:
Sanofi
Conditions:
Aplastic Anaemia
Eligibility:
All Genders
2-90 years
Phase:
PHASE3
Brief 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 demonstr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT01163942
Start Date
March 1 2001
End Date
November 1 2010
Last Update
February 20 2024
Active Locations (71)
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1
University Hospital
Pilsen, Czechia
2
CHU Angers
Angers, France
3
Avicenne Hospital
Bobigny, France
4
University Hospital
Brest, France