Last updated on March 2007

Bortezomib and Low Dose Cytarabine in the Treatment of High-Risk Myelodysplastic Syndromes


Brief description of study

We are evaluating the efficacy of the association of Low dose Cytarabine in association with Bortezomib in the treatment of patients diagnosed with high risk Myelodysplastic syndromes. Our aim is to decrease transfusion requirements and if possible induce a complete or at least a partial remission.

Detailed Study Description

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

Clinical Study Identifier: NCT00411905

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Laurence Sanhes, MD

Centre Hospitalier Joffre
Perpignan, France
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Recruitment Status: Open


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