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

Myelodysplastic Syndromes Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00411905
Study type Interventional
Source Groupe Francophone des Myelodysplasies
Contact Shanti Natarajan-Amé, MD
Phone 00 33 3 88 12 76 70
Email shanti.ame@chru-strasbourg.fr
Status Recruiting
Phase Phase 1/Phase 2
Start date June 2006
Completion date June 2006
View Details
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