Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00391989
Status:
COMPLETED
Last Update Posted:
2017-01-04
First Post:
2006-10-24
Brief Title:
Treatment of Adult Ph LAL With BMS-354825
Sponsor:
Gruppo Italiano Malattie EMatologiche dellAdulto
Organization:
Gruppo Italiano Malattie EMatologiche dellAdulto
Study Overview
Official Title:
A Phase II Multicenter Study on the Treatment of Adult de Novo Philadelphia Chromosome Positive Ph Acute Lymphoblastic Leukemia ALL With the Protein Tyrosine Kinase Inhibitor BMS-354825 EudraCT Number 2005-005107-42
Status:
COMPLETED
Status Verified Date:
2016-11
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:
The primary objective of the trial is to estimate the activity of BMS-354825 Dasatinib in de novo adult Ph ALL patients in terms of hematological complete remission HCR rate
Detailed Description:
This open label phase II study of Dasatinib will enroll adult de novo Ph ALL patients A minimum of 48 cases will be required to complete the study Accrual is expected to be completed in 18 months The study will be considered completed for patients in HCR after completion of a total of 12 weeks of treatment After completion patients will go off study and will be treated according to the best treatment option for Ph ALL patients in 1st HCR The enrollment in the post-remissional phase of the current GIMEMA LAL protocol will be suggested
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