Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00320190
Status:
TERMINATED
Last Update Posted:
2013-10-30
First Post:
2006-05-01
Brief Title:
Study of Dasatinib in Patients With Chronic Phase Chronic Myeloid Leukemia and a Suboptimal Response to Imatinib
Sponsor:
Bristol-Myers Squibb
Organization:
Bristol-Myers Squibb
Study Overview
Official Title:
An Open-label Randomized Study of Dasatinib vs High-dose 800-mg Imatinib in the Treatment of Subjects With Chronic Phase Chronic Myeloid Leukemia Who Have Had a Suboptimal Response After at Least 3 Months of Therapy With 400 mg Imatinib
Status:
TERMINATED
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to slow participant accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare the efficacy of dasatinib with that of high-dose 800-mg imatinib in participants with chronic phase chronic myeloid leukemia who achieved only a suboptimal response after at least 3 months of monotherapy with 400-mg imatinib The safety of these treatments will also be evaluated
Detailed Description:
Participants were randomized 21 to dasatinib or high-dose imatinib respectively Randomization was stratified by a suboptimal response defined as a hematologic response less than a complete hematologic response after at least 3 months of monotherapy with 400-mg imatinib a cytogenic response CgR less than a partial CgR PCgR after at least 6 months of monotherapy with 400-mg a PCgR after at least 12 months of monotherapy with 400-mg imatinib or less than a major molecular response with a complete CgR after at least 18 months of monotherapy with 400-mg imatinib
Participants received either dasatinib or imatinib for 12 months or until disease progression unacceptable toxicity consent withdrawal or study discontinuation After 12 months who had a confirmed major molecular response and were still receiving dasatinib 100 mg or imatinib 800 mg were eligible to extend treatment for an additional 12 months Participants permanently discontinuing treatment before 12 months were considered treatment failures and withdrawn from the study
Participants received either dasatinib or imatinib for 12 months or until disease progression unacceptable toxicity consent withdrawal or study discontinuation After 12 months who had a confirmed major molecular response and were still receiving dasatinib 100 mg or imatinib 800 mg were eligible to extend treatment for an additional 12 months Participants permanently discontinuing treatment before 12 months were considered treatment failures and withdrawn from the study
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 |
|---|---|---|---|
| EUDRACT Number 2005-005153-22 | None | None | None |