Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
Study NCT ID:
NCT00030394
Status:
COMPLETED
Last Update Posted:
2013-01-17
First Post:
2002-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia
Sponsor:
National Cancer Institute (NCI)
Organization:
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 \[closed to accrual as of 12/05/03\] vs CML relapsing after stem cell transplantation or in second or subsequent chronic phase \[closed to accrual as of 7/29/05\] vs newly diagnosed CML in first chronic phase with no prior treatment \[closed to accrual as of 7/29/05\] 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 \[closed to accrual as of 12/05/03\] and stratum II \[closed to accrual as of 7/29/05\], 34 for stratum III \[closed to accrual as of 7/29/05\], 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 \[closed to accrual as of 12/05/03\] vs CML relapsing after stem cell transplantation or in second or subsequent chronic phase \[closed to accrual as of 7/29/05\] vs newly diagnosed CML in first chronic phase with no prior treatment \[closed to accrual as of 7/29/05\] 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 \[closed to accrual as of 12/05/03\] and stratum II \[closed to accrual as of 7/29/05\], 34 for stratum III \[closed to accrual as of 7/29/05\], and 45 for stratum IV) will be accrued for this study within 2 years.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| AAML0123 | None | None | View | |
| U10CA098543 | NIH | None | https://reporter.nih.gov/quic… | View |
| CDR0000069161 | REGISTRY | PDQ (Physician Data Query) | View |