Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00411905
Status:
UNKNOWN
Last Update Posted:
2007-03-12
First Post:
2006-12-14
Brief Title:
Bortezomib and Low Dose Cytarabine in the Treatment of High-Risk Myelodysplastic Syndromes
Sponsor:
Groupe Francophone des Myelodysplasies
Organization:
Groupe Francophone des Myelodysplasies
Study Overview
Official Title:
Phase III Study of Bortezomib and Low Dose Cytarabine in the Treatment of High-Risk Myelodysplastic Syndromes
Status:
UNKNOWN
Status Verified Date:
2006-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 m2day subcutaneous injection for 14 days
Bortézomib 15mgm2 days 14811
Cycles 2 3 4
Cytarabine 20 mg m2j subcutaneous injections for 14 days
Bortézomib 15mgm2 days 14811
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
Cycle 1
Cytarabine 10 mg m2day subcutaneous injection for 14 days
Bortézomib 15mgm2 days 14811
Cycles 2 3 4
Cytarabine 20 mg m2j subcutaneous injections for 14 days
Bortézomib 15mgm2 days 14811
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None