Ignite Creation Date:
2024-05-06 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03114228
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2019-10-15
First Post:
2017-04-11
Brief Title:
An Expanded Treatment Protocol ETP of Midostaurin PKC412 in Patients 18 Years of Age or Older With Newly-diagnosed FLT3-mutated Acute Myeloid Leukemia AML
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
An Open-labeled Multi-Center Expanded Treatment Protocol ETP of Midostaurin PKC412 in Patients 18 Years of Age or Older With Newly-diagnosed FLT3-mutated Acute Myeloid Leukemia AML Who Are Eligible for Standard Induction and Consolidation Chemotherapy
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2019-10
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 gather and evaluate 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 and are without satisfactory treatment alternatives prior to the commercial availability and reimbursement of midostaurin during the regulatory approval process
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