Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00095784
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-08
First Post:
2004-11-09
Brief Title:
Decitabine in Treating Patients With Myelofibrosis
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Decitabine in Myelofibrosis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
This phase II trial studies the side effects and how well decitabine works in treating patients with myelofibrosis a cancer of the blood system associated with fibrosis scar tissue in the bone marrow that is advanced and for which there is no standard therapy Decitabine may block the actions of some proteins that are responsible for turning certain genes off in various cancers including myelofibrosis
Detailed Description:
PRIMARY OBJECTIVES
I To determine response rate complete and partial responses and hematological improvement to decitabine in patients with myelofibrosis
II To determine the safety of decitabine in patients with myelofibrosis
SECONDARY OBJECTIVES
I To determine the effects of decitabine on specific epigenetic changes including methylation status of specific target genes and gene re-expression
II To determine the effect of decitabine on hemoglobin F levels and on the absolute numbers of circulating cluster of differentiation CD 34 progenitor cells and to investigate the potential utility of these markers as a surrogate for biologic activity of decitabine in myeloid metaplasia with myelofibrosis MMM
OUTLINE
Patients receive decitabine subcutaneously SC on days 1-5 and 8-12 Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity
I To determine response rate complete and partial responses and hematological improvement to decitabine in patients with myelofibrosis
II To determine the safety of decitabine in patients with myelofibrosis
SECONDARY OBJECTIVES
I To determine the effects of decitabine on specific epigenetic changes including methylation status of specific target genes and gene re-expression
II To determine the effect of decitabine on hemoglobin F levels and on the absolute numbers of circulating cluster of differentiation CD 34 progenitor cells and to investigate the potential utility of these markers as a surrogate for biologic activity of decitabine in myeloid metaplasia with myelofibrosis MMM
OUTLINE
Patients receive decitabine subcutaneously SC on days 1-5 and 8-12 Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity
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 |
|---|---|---|---|
| NCI-2011-01444 | REGISTRY | None | None |
| CDR0000393839 | None | None | None |
| NCI-6814 | None | None | None |
| UCCRC-13327A | None | None | None |
| 13327A | OTHER | None | None |
| 6814 | OTHER | None | None |
| N01CM62201 | NIH | None | None |
| N01CM62207 | NIH | None | None |
| P30CA014599 | NIH | CTEP | httpsreporternihgovquickSearchP30CA014599 |