NCT00411905

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

Phase I/II Study of Bortezomib and Low Dose Cytarabine in the Treatment of High-risk Myelodysplastic Syndromes

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Groupe Francophone des Myelodysplasies · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	Bortezomib

Timeline

• Start date: 2006-06-01
• Primary completion: 2010-07-08
• Completion: 2011-08-01
• First posted: 2006-12-15
• Last updated: 2025-01-07

Locations

15 sites across 1 country: France