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

• Status: Unknown status
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Groupe Francophone des Myelodysplasies
• Treatments: Bortezomib; Cytarabine

Criteria

Inclusion Criteria:

• MDS with IPSS scores Int-2 or High

• Life expectancy greater than 6 months

• No other available treatment options

Exclusion Criteria:

• MDS with IPSS scores Low or Int-1

• > 30% bone marrow blasts

• clinical neuropathy of greater than grade 2

• ECOG Score 3 or 4

• Creatinine clearance of < 30 ml/min

• LMMC

• Pregnant patients or lactating mothers

• Patients having received intensive chemotherapy in the 3 months prior to inclusion

• Patients with uncontrolled pulmonary, cardiac, neurological, gastro-intestinal or genito-urinary disorders