Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00381693
Status:
TERMINATED
Last Update Posted:
2011-04-21
First Post:
2006-09-26
Brief Title:
Azacitidine in Treating Patients With Myelofibrosis
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Phase II Study of Azacitidine in Myelofibrosis
Status:
TERMINATED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to lack of accrual and trial has demonstrated too little clinical benefit
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as azacitidine work in different ways to stop the growth of abnormal cells either by killing the cells or by stopping them from dividing
PURPOSE This phase II trial is studying how well azacitidine works in treating patients with myelofibrosis
PURPOSE This phase II trial is studying how well azacitidine works in treating patients with myelofibrosis
Detailed Description:
OBJECTIVES
Primary
Determine the efficacy of azacitidine in patients with myelofibrosis MF with myeloid metaplasia
Evaluate the safety of azacitidine in these patients Secondary
Evaluate pertinent biologic characteristics of MF before and during therapy with azacitidine
Assess the effects of study treatment on constitutional symptoms in these patients
Estimate time to event distributions for overall survival and progression OUTLINE Patients receive azacitidine subcutaneously once daily on days 1-5 Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for up to 3 years
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study
Primary
Determine the efficacy of azacitidine in patients with myelofibrosis MF with myeloid metaplasia
Evaluate the safety of azacitidine in these patients Secondary
Evaluate pertinent biologic characteristics of MF before and during therapy with azacitidine
Assess the effects of study treatment on constitutional symptoms in these patients
Estimate time to event distributions for overall survival and progression OUTLINE Patients receive azacitidine subcutaneously once daily on days 1-5 Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for up to 3 years
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-004297 | OTHER | Mayo Clinic IRB | httpsreporternihgovquickSearchP30CA015083 |
| P30CA015083 | NIH | None | None |
| MC058D | OTHER | None | None |