Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028847
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
2002-01-04
Brief Title:
Imatinib Mesylate and Cytarabine in Treating Patients With Newly Diagnosed Chronic Myeloid Leukemia
Sponsor:
Commissie Voor Klinisch Toegepast Onderzoek
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Dose-ranging Phase III Study of STI571 in Combination With Cytarabin in Patients With First Chronic Phase Chronic Myeloid Leukemia
Status:
UNKNOWN
Status Verified Date:
2011-08
Last Known Status:
ACTIVE_NOT_RECRUITING
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 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 Combining imatinib mesylate and chemotherapy may kill more cancer cells
PURPOSE Phase III trial to study the effectiveness of imatinib mesylate plus cytarabine in treating patients who have newly diagnosed chronic myeloid leukemia
PURPOSE Phase III trial to study the effectiveness of imatinib mesylate plus cytarabine in treating patients who have newly diagnosed chronic myeloid leukemia
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of imatinib mesylate and cytarabine in patients with newly diagnosed chronic phase chronic myeloid leukemia
Determine the feasibility of this regimen as defined by dose-limiting toxicity of this regimen and treatment-related mortality in no more than 5 of these patients
Determine the rate and duration of molecular response complete hematological response and complete cytogenetic response in patients treated with this regimen
Determine the time to treatment failure of patients treated with this regimen
Determine the overall survival of patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of imatinib mesylate and cytarabine
Patients receive oral imatinib mesylate alone once daily on days 1-21 Patients then receive oral imatinib mesylate once daily and cytarabine IV over 1-3 hours on days 1-7 Combination therapy repeats every 28-42 days for 2 courses Patients then receive maintenance oral imatinib mesylate once daily Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 5-20 patients receive escalating doses of imatinib mesylate and cytarabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 55 510 or 520 patients experience dose-limiting toxicity
Patients are followed every 6 months
PROJECTED ACCRUAL A total of 30-60 patients will be accrued for this study within 2 years
Determine the maximum tolerated dose of imatinib mesylate and cytarabine in patients with newly diagnosed chronic phase chronic myeloid leukemia
Determine the feasibility of this regimen as defined by dose-limiting toxicity of this regimen and treatment-related mortality in no more than 5 of these patients
Determine the rate and duration of molecular response complete hematological response and complete cytogenetic response in patients treated with this regimen
Determine the time to treatment failure of patients treated with this regimen
Determine the overall survival of patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of imatinib mesylate and cytarabine
Patients receive oral imatinib mesylate alone once daily on days 1-21 Patients then receive oral imatinib mesylate once daily and cytarabine IV over 1-3 hours on days 1-7 Combination therapy repeats every 28-42 days for 2 courses Patients then receive maintenance oral imatinib mesylate once daily Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 5-20 patients receive escalating doses of imatinib mesylate and cytarabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 55 510 or 520 patients experience dose-limiting toxicity
Patients are followed every 6 months
PROJECTED ACCRUAL A total of 30-60 patients 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 IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NOVARTIS-CST1571ANL01 | None | None | None |
| CKTO-2001-03 | None | None | None |
| HOVON-51CML | None | None | None |
| EU-20132 | None | None | None |
| HOVON-CKTO-2001-03 | None | None | None |