Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039416
Status:
COMPLETED
Last Update Posted:
2014-02-25
First Post:
2002-06-06
Brief Title:
Imatinib Mesylate in Treating Patients With Myelofibrosis
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study Of Gleevec Imatinib Mesylate Formerly Known as STI-571 In Patients With Myelofibrosis
Status:
COMPLETED
Status Verified Date:
2012-12
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:
Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have myelofibrosis Imatinib mesylate may stop the growth of myelofibrosis by blocking certain enzymes necessary for cell growth
Detailed Description:
PRIMARY OBJECTIVES
I To determine the response rate complete and partial to STI-571 in patients with myelofibrosis
II To determine the safety of STI-571 in patients with myelofibrosis
SECONDARY OBJECTIVES
I To determine the effects of STI-571 on bone marrow morphology including effects on marrow fibrosis osteosclerosis and cellularity in patients with myelofibrosis
II To assess the effects of STI-571 on surrogate biologic endpoints including PDGFR expression by immunohistochemistry PDGFR signaling and circulating progenitor CD34 positive cells
III To determine the effects of STI-571 on bone marrow cytogenetics in patients with an abnormal karyotype
OUTLINE This is a multicenter study Patients are stratified according to Dupriez risk score low vs intermediate vs high
Patients receive oral imatinib mesylate once or twice daily on days 1-28 Courses repeat every 28 days for 12 months in the absence of disease progression or unacceptable toxicity
I To determine the response rate complete and partial to STI-571 in patients with myelofibrosis
II To determine the safety of STI-571 in patients with myelofibrosis
SECONDARY OBJECTIVES
I To determine the effects of STI-571 on bone marrow morphology including effects on marrow fibrosis osteosclerosis and cellularity in patients with myelofibrosis
II To assess the effects of STI-571 on surrogate biologic endpoints including PDGFR expression by immunohistochemistry PDGFR signaling and circulating progenitor CD34 positive cells
III To determine the effects of STI-571 on bone marrow cytogenetics in patients with an abnormal karyotype
OUTLINE This is a multicenter study Patients are stratified according to Dupriez risk score low vs intermediate vs high
Patients receive oral imatinib mesylate once or twice daily on days 1-28 Courses repeat every 28 days for 12 months 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 |
|---|---|---|---|
| P30CA014599 | NIH | CTEP | httpsreporternihgovquickSearchP30CA014599 |
| NCI-2012-02895 | REGISTRY | None | None |
| CDR0000069381 | None | None | None |
| 11498A | OTHER | None | None |
| 5669 | OTHER | None | None |
| N01CM62201 | NIH | None | None |