Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00384956
Status:
COMPLETED
Last Update Posted:
2016-12-12
First Post:
2006-10-04
Brief Title:
A Phase II Study of Intravenous Azacitidine Alone in Patients With Myelodysplastic Syndromes
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
A Phase II Study of Intravenous Azacitidine Alone in Patients With Myelodysplastic Syndromes
Status:
COMPLETED
Status Verified Date:
2016-10
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:
The primary endpoint of this study is to estimate morphologic complete remission rate Estimation of response rate is also a secondary objection
Detailed Description:
Myelodysplastic syndrome MDS is a hematological disorder characterized by ineffective hematopoiesis The only known curative treatment for patients with MDS is allogeneic stem cell transplantation However only a minority of patients are candidates for this aggressive therapy DNA hypomethylation agents have been shown to have activity in this disorder and are postulated to work by reversing this epigenetic mechanism of gene-silencing Recently 5-azacitidine administered subcutaneously for seven days received approval by the FDA for the therapy of MDS based on a randomized trial which demonstrated a diminished risk of leukemic transformation and improved survival when compared to best supportive care
The subcutaneous route of administration can present challenges to implementing this therapy In the CALGB studies 8921 and 9221 approximately 23 of patients had significant injection site pain Moreover 35 of patients had injection site bruising which can be extensive in thrombocytopenic patients Due to limitations on drug concentration and administration volumes for subcutaneous dosing patients often need to have two or three injections at separate sites each day to meet target dosing In addition the schedule of administration is inconvenient in an outpatient setting secondary to the need to schedule administrations over weekends Therefore there is great interest in pursuing an abbreviated intravenous route for administration of the drug
The subcutaneous route of administration can present challenges to implementing this therapy In the CALGB studies 8921 and 9221 approximately 23 of patients had significant injection site pain Moreover 35 of patients had injection site bruising which can be extensive in thrombocytopenic patients Due to limitations on drug concentration and administration volumes for subcutaneous dosing patients often need to have two or three injections at separate sites each day to meet target dosing In addition the schedule of administration is inconvenient in an outpatient setting secondary to the need to schedule administrations over weekends Therefore there is great interest in pursuing an abbreviated intravenous route for administration of the drug
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