Viewing Study NCT01883362



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Last Modification Date: 2024-10-26 @ 11:08 AM
Study NCT ID: NCT01883362
Status: COMPLETED
Last Update Posted: 2021-03-17
First Post: 2013-03-25

Brief Title: Standard of Care - Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML
Sponsor: Novartis Pharmaceuticals
Organization: Novartis

Study Overview

Official Title: A Phase II Randomized Trial of Standard of Care With or Without Midostaruin to Prevent Relapse Following Allogeneic Hematopoietic Stem Cell Transplantation in Patients With FLT3-ITD Mutated Acute Myeloid Leukemia
Status: COMPLETED
Status Verified Date: 2021-03
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: RADIUS
Brief Summary: To determine if the addition of midostaurin PKC412 to Standard of Care SOC therapy reduces relapse in FLT3-ITD mutated AML patients receiving an allogenetic hematopoietic stem cell transplant
Detailed Description: None

Study Oversight

Has Oversight DMC: None
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?: None
Is an FDA AA801 Violation?: None