Randomized Study In Severe Aplastic Anemia Patients Receiving Atg, Cyclosporin A, With Or Without G-CSF (SAA-G-CSF)
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.
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.
Study Design
Allocation: Randomized, Control: Placebo Control, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Aplastic Anaemia
Intervention
G-CSF, Early retreatment with ATG
Location
St. Louis Hospital
Paris
France
Sw17 0RE
Status
Terminated
Source
European Group for Blood and Marrow Transplantation
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01163942
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Retreatment
The therapy of the same disease in a patient, with the same agent or procedure repeated after initial treatment, or with an additional or alternate measure or follow-up. It does not include therapy which requires more than one administration of a therapeutic agent or regimen. Retreatment is often used with reference to a different modality when the original one was inadequate, harmful, or unsuccessful.
Anemia, Aplastic
A form of anemia in which the bone marrow fails to produce adequate numbers of peripheral blood elements.
Early Diagnosis
Methods to determine in patients the nature of a disease or disorder at its early stage of progression. Generally, early diagnosis improves PROGNOSIS and TREATMENT OUTCOME.
Early Detection Of Cancer
Methods to identify and characterize cancer in the early stages of disease and predict tumor behavior.
Early Growth Response Protein 1
An early growth response transcription factor that has been implicated in regulation of CELL PROLIFERATION and APOPTOSIS.
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PubMed Articles
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In this interesting paper, "Decreased plasma cytokines associate with low platelet counts in aplastic anemia and immune thrombocytopenic purpura", Feng et al(1) follow on from earlier studies of cytok...
Success of allogeneic marrow transplantation for children with severe aplastic anaemia.
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The pathology of bone marrow failure.
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