Ignite Creation Date:
2024-05-06 @ 7:54 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02624570
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2020-07-15
First Post:
2015-12-03
Brief Title:
Midostaurin Access Program for Newly Diagnosed FLT3 ITD or TKD Mutated AML Adult Patients Eligible for Standard Induction and Consolidation Chemotherapy
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
An Open-label Multi-center Expanded Treatment Protocol of Midostaurin PKC412 in Adult Patients With Newly Diagnosed Fms-like Tyrosine Kinase Receptor FLT3 Mutated Acute Myeloid Leukemia AML Who Are Eligible for Standard Induction and Consolidation Chemotherapy
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMLFLT3
Brief Summary:
The purpose of this study is to provide access to Midostaurin and gather additional safety data on the combination of Midostaurin and standard of care for adult patients with newly diagnosed Fms-like tyrosine kinase receptor FLT3 mutated Acute Myeloid Leukemia AML who are eligible for standard induction and consolidation chemotherapy
Detailed Description:
The purpose of this study is to provide Midostaurin study drug treatment to newly diagnosed FLT3 mutated ITD or TKD AML adult patients 18 years or older eligible for standard standard induction cytarabine daunorubicinIdarubicin and consolidation cytarabine chemotherapy
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