Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012259
Status:
COMPLETED
Last Update Posted:
2021-06-10
First Post:
2001-03-03
Brief Title:
Troxacitabine in Treating Patients With Chronic Myelogenous Leukemia
Sponsor:
Shire
Organization:
Takeda
Study Overview
Official Title:
A Phase II Study Of Troxatyl In Patients With CML Blastic Phase Disease
Status:
COMPLETED
Status Verified Date:
2021-06
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
PURPOSE Phase II trial to study the effectiveness of troxacitabine in treating patients who have blast phase chronic myelogenous leukemia
PURPOSE Phase II trial to study the effectiveness of troxacitabine in treating patients who have blast phase chronic myelogenous leukemia
Detailed Description:
OBJECTIVES I Determine the response rate in terms of achieving complete hematologic remission partial hematologic remission hematologic improvement partial response or back to chronic phase status in patients with blastic phase chronic myelogenous leukemia treated with troxacitabine II Determine the proportion of patients whose disease returns to chronic phase and remains at that level for at least 3 months when treated with this drug III Determine the toxicity profile of this drug in these patients IV Determine the duration of survival of patients treated with this drug
OUTLINE This is a multicenter study Patients receive troxacitabine IV over 30 minutes on days 1-5 Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity Patients are followed every 4 weeks until relapse
PROJECTED ACCRUAL A maximum of 50 patients will be accrued for this study within 14 months
OUTLINE This is a multicenter study Patients receive troxacitabine IV over 30 minutes on days 1-5 Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity Patients are followed every 4 weeks until relapse
PROJECTED ACCRUAL A maximum of 50 patients will be accrued for this study within 14 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 |
|---|---|---|---|
| NCI-V01-1648 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068498 | REGISTRY | None | None |