Phase I/II Study of Bortezomib and Low Dose Cytarabine in the Treatment of High-Risk Myelodysplastic Syndromes
Four cycles of treatment are proposed at 28 day intervals in an ambulatory setting
Cycle 1 :
- Cytarabine 10 mg /m2/day subcutaneous injection for 14 days
- Bortézomib 1,5mg/m2 days 1,4,8,11
Cycles 2, 3, 4 :
- Cytarabine 20 mg /m2/j subcutaneous injections for 14 days
- Bortézomib 1,5mg/m2 days 1,4,8,11
Bone marrow aspirates are evaluated just before the first cycle, after the second and after
the fourth cycles
Responding patients may continue the treatment for 2 further cycles
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete Response
Francois DREYFUS, MD PhD
Principal Investigator
Groupe francaise des Myelodysplasies
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
GFM BAR-C-2005
NCT00411905
June 2006
June 2006
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