Status:
COMPLETED
Bortezomib and Low Dose Cytarabine in the Treatment of High-risk Myelodysplastic Syndromes
Lead Sponsor:
Groupe Francophone des Myelodysplasies
Collaborating Sponsors:
Johnson & Johnson
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 d...
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...
Eligibility Criteria
Inclusion
- MDS with IPSS scores Int-2 or High
- Life expectancy greater than 6 months
- No other available treatment options
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00411905
Start Date
June 1 2006
End Date
August 1 2011
Last Update
January 7 2025
Active Locations (15)
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1
CHU Angers
Angers, France, 43033
2
Hopital Avicenne
Bobigny, France, 93009
3
Institut Bergonie
Bordeaux, France, 33076
4
CHU de Caen
Caen, France, 14033