Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00268229
Status:
COMPLETED
Last Update Posted:
2013-02-15
First Post:
2005-12-20
Brief Title:
Imatinib Mesylate Daunorubicin and Cytarabine in Treating Patients With Relapsed Acute Myeloid Leukemia
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
A Phase I Trial of Imatinib Mesylate Gleevec Formerly Known as STI571 in Combination With Daunorubicin and Cytarabine for C-kit Positive Relapsed AML
Status:
COMPLETED
Status Verified Date:
2013-02
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 Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy such as daunorubicin and cytarabine work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving imatinib mesylate together with daunorubicin and cytarabine may kill more cancer cells
PURPOSE This phase I trial is studying the side effects and best dose of imatinib mesylate when given together with daunorubicin and cytarabine in treating patients with relapsed acute myeloid leukemia
PURPOSE This phase I trial is studying the side effects and best dose of imatinib mesylate when given together with daunorubicin and cytarabine in treating patients with relapsed acute myeloid leukemia
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose MTD and recommended phase II dose of imatinib mesylate in combination with daunorubicin hydrochloride and cytarabine in patients with relapsed acute myeloid leukemia
Secondary
Assess the non-dose-limiting toxicities associated with this regimen in these patients
Determine any preliminary evidence of clinical activity of this regimen in these patients
OUTLINE This is an open-label dose-escalation study of imatinib mesylate
Patients receive daunorubicin IV on days 1-3 and cytarabine IV continuously on days 1-7 Patients also receive oral imatinib mesylate once daily beginning on day 1 and continuing until disease progression or unacceptable toxicity Patients with persistent leukemia on day 14 bone marrow biopsy but 50 reduction in bone marrow blasts receive 5 more days of cytarabine and 2 more days of daunorubicin while continuing imatinib mesylate
Cohorts of 3-6 patients receive escalating doses of imatinib mesylate until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 1 of 3 or 2 of 6 patients experience dose-limiting toxicity At least 6 patients are treated at the MTD
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 24 patients will be accrued for this study
Primary
Determine the maximum tolerated dose MTD and recommended phase II dose of imatinib mesylate in combination with daunorubicin hydrochloride and cytarabine in patients with relapsed acute myeloid leukemia
Secondary
Assess the non-dose-limiting toxicities associated with this regimen in these patients
Determine any preliminary evidence of clinical activity of this regimen in these patients
OUTLINE This is an open-label dose-escalation study of imatinib mesylate
Patients receive daunorubicin IV on days 1-3 and cytarabine IV continuously on days 1-7 Patients also receive oral imatinib mesylate once daily beginning on day 1 and continuing until disease progression or unacceptable toxicity Patients with persistent leukemia on day 14 bone marrow biopsy but 50 reduction in bone marrow blasts receive 5 more days of cytarabine and 2 more days of daunorubicin while continuing imatinib mesylate
Cohorts of 3-6 patients receive escalating doses of imatinib mesylate until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 1 of 3 or 2 of 6 patients experience dose-limiting toxicity At least 6 patients are treated at the MTD
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 24 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 |
|---|---|---|---|
| CASE-CCF-6441 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA043703 |
| P30CA043703 | NIH | None | None |