Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00130195
Status:
COMPLETED
Last Update Posted:
2008-11-14
First Post:
2005-08-12
Brief Title:
Study of Imatinib-Combined Chemotherapy for BCR-ABL-Positive Acute Lymphoblastic Leukemia ALL
Sponsor:
Japan Adult Leukemia Study Group
Organization:
Japan Adult Leukemia Study Group
Study Overview
Official Title:
Phase 2 Study of Imatinib-Combined Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia
Status:
COMPLETED
Status Verified Date:
2008-11
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 purpose of this study is to determine the clinical efficacy and safety of imatinib-combined chemotherapy on newly diagnosed BCR-ABL-positive ALL
Detailed Description:
Philadelphia chromosome Ph is a translocation abnormality leading to the formation of the BCR-ABL gene rearrangement This genetic abnormality occurs in up to 30 of adult acute lymphoblastic leukemia ALL and its presence is known to be the most adverse prognostic factor for ALL Because long-term survival cannot be achieved by conventional chemotherapy alone there is a clear medical need for alternative treatment approaches Imatinib is a potent selective inhibitor of the BCR-ABL protein kinase and it has been reported that single-agent imatinib induced response in a substantial proportion of Ph-positive ALL PhALL patients but that the response was not durable The Japan Adult Leukemia Study Group JALSG has therefore started a phase 2 study designed to evaluate the clinical effect of imatinib-combined chemotherapy on newly diagnosed BCR-ABL-positive ALL
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