Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00514969
Status:
COMPLETED
Last Update Posted:
2007-08-10
First Post:
2007-08-09
Brief Title:
Protein-Tyrosine Kinase Inhibitor STI571 for Treatment of Patients With Ph Chronic Myeloid Leukemia in Accelerated and Blastic Phase
Sponsor:
University of Bologna
Organization:
University of Bologna
Study Overview
Official Title:
Protein-Tyrosine Kinase Inhibitor STI571 for Treatment of Patients With Ph Chronic Myeloid Leukemia in Accelerated and Blastic Phase A Phase II Study
Status:
COMPLETED
Status Verified Date:
2007-07
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:
CML003
Brief Summary:
This is a phase II multi-center open-label non-randomized trial During Part 1 of the trial patients will receive once daily oral administration of STI571 at a dose of 600 mg for 24 weeks After completing 24 weeks of therapy patients may be eligible to receive additional therapy during Part 2 of the trial provided that in the opinion of the investigator the patient has benefited from treatment with STI571 and in the absence of safety concerns During Part 2 which is of indefinite duration patients will continue to receive STI571 on a daily basis until either death the development of intolerable toxicity or the investigator feels it is no longer in the patients best interest to continue therapy whichever comes first
Detailed Description:
None
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