Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00451997
Status:
COMPLETED
Last Update Posted:
2012-08-01
First Post:
2007-03-23
Brief Title:
GleevecLow-Dose Ara-C Study for Elderly Patients With AML and Myelodysplastic Syndromes
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Trial of Gleevec and Low-Dose Ara-C for Elderly Patients With C-Kit Positive Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndromes
Status:
COMPLETED
Status Verified Date:
2012-07
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:
None
Brief Summary:
The goal of this clinical research study is to learn if the combination of Gleevec imatinib mesylate and low doses of Cytarabine ara-C may help to control leukemia while causing fewer side effects than standard high dose chemotherapy
Detailed Description:
Imatinib mesylate is a drug that blocks a certain protein This protein is thought to be important in the growth of leukemia cells Ara-C is a chemotherapy drug that has been used for many years to treat AML and MDS
Imatinib mesylate Gleevec is a protein-tyrosine kinase inhibitor that inhibits the Bcr-Abl tyrosine kinase as well as the receptor tyrosine kinases for platelet- derived growth factor PDGF and stem cell factor SCF c-Kit and inhibits PDGF- and SCF-mediated cellular events c-Kit is expressed in over 90 of patients with AML
The treatment of AML for patients age 65 or older with AML or high-risk MDS age ³ 60 if high-risk cytogenetics have a poor prognosis with induction chemotherapy Response rate is no more than 45 with an induction mortality of at least 25 and 1-year survival no better than 20 Indeed most patients in these age groups are not even offered therapy and are managed with supportive care only Thus new therapies that are better tolerated are needed
Imatinib alone can induce response in nearly 20 of patients and there is synergy with low concentrations of ara-C In this study we plan to investigate the combination of imatinib and low-dose ara-C
Imatinib mesylate Gleevec is a protein-tyrosine kinase inhibitor that inhibits the Bcr-Abl tyrosine kinase as well as the receptor tyrosine kinases for platelet- derived growth factor PDGF and stem cell factor SCF c-Kit and inhibits PDGF- and SCF-mediated cellular events c-Kit is expressed in over 90 of patients with AML
The treatment of AML for patients age 65 or older with AML or high-risk MDS age ³ 60 if high-risk cytogenetics have a poor prognosis with induction chemotherapy Response rate is no more than 45 with an induction mortality of at least 25 and 1-year survival no better than 20 Indeed most patients in these age groups are not even offered therapy and are managed with supportive care only Thus new therapies that are better tolerated are needed
Imatinib alone can induce response in nearly 20 of patients and there is synergy with low concentrations of ara-C In this study we plan to investigate the combination of imatinib and low-dose ara-C
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