Spots Global Cancer Trial Database for Bortezomib and Low Dose Cytarabine in the Treatment of High-Risk Myelodysplastic Syndromes

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

Official Title: Phase I/II Study of Bortezomib and Low Dose Cytarabine in the Treatment of High-Risk Myelodysplastic Syndromes

Study ID: NCT00411905

Conditions

Myelodysplastic Syndromes

Interventions

Bortezomib

Study Description

Brief Summary: 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 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