Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-01-07 @ 3:28 AM
Study NCT ID:
NCT03207334
Status:
WITHDRAWN
Last Update Posted:
2018-10-22
First Post:
2017-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
iCare4: Genomic Signatures With Midostaurin in Acute Myeloid Leukemia (UF-HEM-004)
Sponsor:
University of Florida
Organization:
Study Overview
Official Title:
A Phase II, Open-Label Clinical Efficacy Study Defining Genomic Signatures That Correlate With Midostaurin Response in Relapsed or Refractory Acute Myeloid Leukemia (AML)
Status:
WITHDRAWN
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open label, single arm study of midostaurin in patients with relapsed or refractory AML.
Detailed Description:
Clinical trials have shown that the multi-kinase inhibitor midostaurin improves survival in patients with AML. The main objective of this study is to investigate its effect (in conjunction with cytarabine) on progression free survival, as well as overall survival and morphologic response rate in patients with relapsed or refractory AML. This study will also attempt to identify specific populations of patients with relapsed or refractory AML who best respond to treatment with midostaurin to enhance treatment planning.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: