Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT00411905
Status:
COMPLETED
Last Update Posted:
2025-01-07
First Post:
2006-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bortezomib and Low Dose Cytarabine in the Treatment of High-risk Myelodysplastic Syndromes
Sponsor:
Groupe Francophone des Myelodysplasies
Organization:
Study Overview
Official Title:
Phase I/II Study of Bortezomib and Low Dose Cytarabine in the Treatment of High-risk Myelodysplastic Syndromes
Status:
COMPLETED
Status Verified Date:
2010-07
Last Known Status:
None
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 /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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: