Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00345826
Status:
COMPLETED
Last Update Posted:
2013-01-08
First Post:
2006-06-28
Brief Title:
Dasatinib in Treating Patients With Chronic Myelogenous Leukemia or Acute Lymphoblastic Leukemia
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
Long-Term Safety and Efficacy of Dasatinib BMS-354825 in Subjects Who Experienced Clinical Benefit on Protocol CA 180-002
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 Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth
PURPOSE This phase I trial is studying the side effects of dasatinib in treating patients with chronic myelogenous leukemia or acute lymphoblastic leukemia
PURPOSE This phase I trial is studying the side effects of dasatinib in treating patients with chronic myelogenous leukemia or acute lymphoblastic leukemia
Detailed Description:
OBJECTIVES
Primary
Determine the long-term safety and tolerability of dasatinib in patients with Philadelphia chromosome-positive chronic myelogenous leukemia or acute lymphoblastic leukemia resistant or intolerant to imatinib mesylate
Secondary
Describe any hematologic or cytogenetic response in patients treated with this drug
Determine the duration of hematologic and cytogenetic response in patients using this drug during trial UCLA-0303035
Determine the progression-free survival and overall survival of patients treated with this drug
OUTLINE This is an open-label roll-over study of protocol UCLA-0303035
Patients receive oral dasatinib once or twice daily for 5 6 or 7 days Treatment repeats every 7 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for 5 years
PROJECTED ACCRUAL A total of 54 patients will be accrued for this study
Primary
Determine the long-term safety and tolerability of dasatinib in patients with Philadelphia chromosome-positive chronic myelogenous leukemia or acute lymphoblastic leukemia resistant or intolerant to imatinib mesylate
Secondary
Describe any hematologic or cytogenetic response in patients treated with this drug
Determine the duration of hematologic and cytogenetic response in patients using this drug during trial UCLA-0303035
Determine the progression-free survival and overall survival of patients treated with this drug
OUTLINE This is an open-label roll-over study of protocol UCLA-0303035
Patients receive oral dasatinib once or twice daily for 5 6 or 7 days Treatment repeats every 7 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for 5 years
PROJECTED ACCRUAL A total of 54 patients will be accrued for this 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 |
|---|---|---|---|
| BMS-CA180039 | None | None | None |
| UCLA-0509010-01 | None | None | None |