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

Flagship AA trial

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.

2001-03-01

2008-06-01

2010-11-01

Terminated

Early phase I

205

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 205, 'type': 'ACTUAL'}}

2024-02-20