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

Groupe Francophone des Myelodysplasies

Status and phase: Completed; Phase 2; Phase 1

Conditions: Myelodysplastic Syndromes

Treatments: Drug: Bortezomib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00411905

GFM BAR-C-2005

Details and patient eligibility

About

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.

Full 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

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)