Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006052
Status:
COMPLETED
Last Update Posted:
2014-01-31
First Post:
2000-07-05
Brief Title:
STI571 in Treating Patients With Accelerated Phase Chronic Myelogenous Leukemia
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
A Study to Determine the Efficacy and Safety of STI571 in Patients With Chronic Myeloid Leukemia in Accelerated Phase
Status:
COMPLETED
Status Verified Date:
2014-01
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:
RATIONALE STI571 may interfere with the growth of cancer cells and may be effective treatment for chronic myelogenous leukemia
PURPOSE Phase II trial to study the effectiveness of STI571 in treating patients who have accelerated phase chronic myelogenous leukemia
PURPOSE Phase II trial to study the effectiveness of STI571 in treating patients who have accelerated phase chronic myelogenous leukemia
Detailed Description:
OBJECTIVES I Determine the safety of STI571 in patients with accelerated phase Philadelphia chromosome positive or chromosome negative and BcrAbl positive chronic myelogenous leukemia II Determine the rate of hematological response to this treatment in these patients III Determine the improvements in symptomatic parameters with this treatment in these patients IV Determine the cytogenetic response to this treatment in these patients V Determine the time to treatment failure in these patients after receiving this treatment
OUTLINE Patients receive oral STI571 daily Treatment continues for at least 1 year in the absence of disease progression or unacceptable toxicity Patients who are considered to have benefited may continue treatment beyond 1 year
PROJECTED ACCRUAL Not determined
OUTLINE Patients receive oral STI571 daily Treatment continues for at least 1 year in the absence of disease progression or unacceptable toxicity Patients who are considered to have benefited may continue treatment beyond 1 year
PROJECTED ACCRUAL Not determined
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 |
|---|---|---|---|
| MSKCC-00094 | None | None | None |
| NOVARTIS-STI5710114 | None | None | None |