Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054431
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
2003-02-05
Brief Title:
Imatinib Mesylate and Decitabine in Treating Patients With Chronic Myelogenous Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Imatinib Mesylate Gleevec STI-571 NSC716051 and Decitabine 5-AZA-2-Deoxycitidine NSC127716 in Chronic Myelogenous Leukemia in Accelerated and Blastic Phases
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 how well giving imatinib mesylate together with decitabine works in treating patients with accelerated or blast phase chronic myelogenous leukemia Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Giving imatinib mesylate together with decitabine may kill more cancer cells
Detailed Description:
OBJECTIVES
I Determine the duration of response and response rate in patients with accelerated or blastic phase chronic myelogenous leukemia treated with imatinib mesylate and decitabine
II Determine the survival rate of patients treated with this regimen III Determine the toxicity of this regimen in these patients IV Determine the effects of this regimen on gene methylation in the leukemic cells of these patients
OUTLINE Patients are stratified according to prior exposure to imatinib mesylate yes vs no
Patients receive oral imatinib mesylate daily and decitabine IV over 1 hour daily 5 days per week for 2 consecutive weeks Courses repeat every 4-6 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 20-80 patients 10-40 per stratum will be accrued for this study within 20 months
I Determine the duration of response and response rate in patients with accelerated or blastic phase chronic myelogenous leukemia treated with imatinib mesylate and decitabine
II Determine the survival rate of patients treated with this regimen III Determine the toxicity of this regimen in these patients IV Determine the effects of this regimen on gene methylation in the leukemic cells of these patients
OUTLINE Patients are stratified according to prior exposure to imatinib mesylate yes vs no
Patients receive oral imatinib mesylate daily and decitabine IV over 1 hour daily 5 days per week for 2 consecutive weeks Courses repeat every 4-6 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 20-80 patients 10-40 per stratum will be accrued for this study within 20 months
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 |
|---|---|---|---|
| CDR0000270678 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM62202 |
| MDA-ID-02205 | None | None | None |
| N01CM62202 | NIH | None | None |