Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006053
Status:
COMPLETED
Last Update Posted:
2013-01-18
First Post:
2000-07-05
Brief Title:
STI571 in Treating Patients With Chronic Myelogenous Leukemia That Has Not Responded to Interferon Alfa
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
A Study to Determine the Safety and Efficacy of STI571 in Patients With Chronic Myeloid Leukemia Who Are Hematologically or Cytogenetically Resistant or Refractory to Interferon-Alpha or Intolerant of Interferon-Alpha
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:
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 chronic myeloid leukemia that has not responded to interferon alfa
PURPOSE Phase II trial to study the effectiveness of STI571 in treating patients who have chronic myeloid leukemia that has not responded to interferon alfa
Detailed Description:
OBJECTIVES I Evaluate the safety profile of STI571 in patients with Philadelphia chromosome positive or chromosome negative and BcrAbl positive chronic phase chronic myelogenous leukemia who are refractory to or intolerant of interferon alfa II Provide expanded access of this treatment to these patients III Confirm the rate of complete and major cytogenetic response in patients treated with this regimen as demonstrated by a decrease in the percentage of Philadelphia chromosome positive cells in the bone marrow IV Evaluate the improvement of symptomatic parameters in patients treated with this regimen
OUTLINE This is an expanded access multicenter study Patients receive oral STI571 daily Treatment continues for 12 months in the absence of disease progression or unacceptable toxicity Patients who respond after 12 months may continue with therapy
PROJECTED ACCRUAL Not determined
OUTLINE This is an expanded access multicenter study Patients receive oral STI571 daily Treatment continues for 12 months in the absence of disease progression or unacceptable toxicity Patients who respond after 12 months may continue with therapy
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 |
|---|---|---|---|
| MCC-12348 | None | None | None |
| NOVARTIS-CSTI5710113 | None | None | None |