Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022490
Status:
TERMINATED
Last Update Posted:
2016-01-07
First Post:
2001-08-10
Brief Title:
Imatinib Mesylate Plus Cytarabine in Treating Patients With Chronic Myelogenous Leukemia
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
A Phase II Study To Determine The Anti-Leukemic Effects Of STI571 In Combination With Ara-C In Patients With Chronic Myelogenous Leukemia In Chronic Phase
Status:
TERMINATED
Status Verified Date:
2015-12
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:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth
PURPOSE This phase II trial is studying giving imatinib mesylate together with cytarabine to see how well it works in treating patients with chronic phase chronic myelogenous leukemia
PURPOSE This phase II trial is studying giving imatinib mesylate together with cytarabine to see how well it works in treating patients with chronic phase chronic myelogenous leukemia
Detailed Description:
OBJECTIVES
Determine the rate and duration of complete or major and minor cytogenetic responses after 6 and 12 months of treatment in patients with chronic phase chronic myelogenous leukemia treated with imatinib mesylate and cytarabine
Determine the rate and duration of complete hematologic responses after 6 and 12 months of treatment in patients treated with this regimen
Determine the rate of molecular response in patients with a complete cytogenetic response after 6 and 12 months of treatment with this regimen
Determine the pharmacokinetics of this regimen in these patients
Determine the safety of this regimen in these patients
OUTLINE This is a nonrandomized open-label multicenter study
Patients receive oral imatinib mesylate on days 1-28 and cytarabine subcutaneously on days 15-28 Courses repeat every 28 days for 12 months in the absence of disease progression or unacceptable toxicity
Patients are followed for 30-60 days
PROJECTED ACCRUAL A total of 15 patients will be accrued for this study
Determine the rate and duration of complete or major and minor cytogenetic responses after 6 and 12 months of treatment in patients with chronic phase chronic myelogenous leukemia treated with imatinib mesylate and cytarabine
Determine the rate and duration of complete hematologic responses after 6 and 12 months of treatment in patients treated with this regimen
Determine the rate of molecular response in patients with a complete cytogenetic response after 6 and 12 months of treatment with this regimen
Determine the pharmacokinetics of this regimen in these patients
Determine the safety of this regimen in these patients
OUTLINE This is a nonrandomized open-label multicenter study
Patients receive oral imatinib mesylate on days 1-28 and cytarabine subcutaneously on days 15-28 Courses repeat every 28 days for 12 months in the absence of disease progression or unacceptable toxicity
Patients are followed for 30-60 days
PROJECTED ACCRUAL A total of 15 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 |
|---|---|---|---|
| NCI-4653 | Other Identifier | OHSU Knight Cancer Institute | None |
| OHSU-NCI-4653 | None | None | None |
| OHSU-1184 | OTHER | None | None |
| OHSU-HEM-01017-LX | OTHER | None | None |