Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030394
Status:
COMPLETED
Last Update Posted:
2013-01-17
First Post:
2002-02-14
Brief Title:
Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Gleevec in Ph Chronic Phase Chronic Myelogenous Leukemia
Status:
COMPLETED
Status Verified Date:
2013-01
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 is studying imatinib mesylate to see how well it works in treating patients with chronic myelogenous leukemia Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth
Detailed Description:
OBJECTIVES
I Determine the response rate in patients with Philadelphia chromosome positive chronic phase chronic myelogenous leukemia treated with imatinib mesylate
II Determine the disease-free survival of patients treated with this drug III Determine the pharmacokinetics of this drug in these patients IV Determine the toxic effects of this drug in these patients V Determine the rates of hematological cytogenetic and molecular response and time to response in patients treated with this drug
OUTLINE This is a multicenter study Patients are stratified according to disease chronic myelogenous leukemia CML in first chronic phase after failing interferon therapy or demonstrating intolerance to interferon closed to accrual as of 120503 vs CML relapsing after stem cell transplantation or in second or subsequent chronic phase closed to accrual as of 72905 vs newly diagnosed CML in first chronic phase with no prior treatment closed to accrual as of 72905 vs newly diagnosed CML in first chronic phase with no prior treatment
Patients receive oral imatinib mesylate once daily on days 1-28 Courses repeat every 28 days for 1 year in the absence of disease progression or unacceptable toxicity Patients who fail to achieve a complete hematologic response after 3 courses or a partial or complete cytogenic response after 6 courses are removed from the study
PROJECTED ACCRUAL A total of 109 patients 30 for stratum I closed to accrual as of 120503 and stratum II closed to accrual as of 72905 34 for stratum III closed to accrual as of 72905 and 45 for stratum IV will be accrued for this study within 2 years
I Determine the response rate in patients with Philadelphia chromosome positive chronic phase chronic myelogenous leukemia treated with imatinib mesylate
II Determine the disease-free survival of patients treated with this drug III Determine the pharmacokinetics of this drug in these patients IV Determine the toxic effects of this drug in these patients V Determine the rates of hematological cytogenetic and molecular response and time to response in patients treated with this drug
OUTLINE This is a multicenter study Patients are stratified according to disease chronic myelogenous leukemia CML in first chronic phase after failing interferon therapy or demonstrating intolerance to interferon closed to accrual as of 120503 vs CML relapsing after stem cell transplantation or in second or subsequent chronic phase closed to accrual as of 72905 vs newly diagnosed CML in first chronic phase with no prior treatment closed to accrual as of 72905 vs newly diagnosed CML in first chronic phase with no prior treatment
Patients receive oral imatinib mesylate once daily on days 1-28 Courses repeat every 28 days for 1 year in the absence of disease progression or unacceptable toxicity Patients who fail to achieve a complete hematologic response after 3 courses or a partial or complete cytogenic response after 6 courses are removed from the study
PROJECTED ACCRUAL A total of 109 patients 30 for stratum I closed to accrual as of 120503 and stratum II closed to accrual as of 72905 34 for stratum III closed to accrual as of 72905 and 45 for stratum IV will be accrued for this study within 2 years
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 |
|---|---|---|---|
| AAML0123 | None | None | None |
| U10CA098543 | NIH | None | None |
| CDR0000069161 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA098543 |