Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-31 @ 3:44 AM
Study NCT ID:
NCT04678466
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2022-05-31
First Post:
2020-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Flotetuzumab Expanded Access Program
Sponsor:
MacroGenics
Organization:
Study Overview
Official Title:
An Expanded Access Program Providing Flotetuzumab in the Treatment of Acute Myeloid Leukemia Patients in Single, Individually-approved Patients
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2022-05
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 the Expanded Access program is to provide flotetuzumab to patients with acute myeloid leukemia (AML) for whom potential benefit justifies potential treatment risks.
Detailed Description:
MacroGenics will consider, on a case-by-case basis, requests by treating physicians to file a single patient investigational new drug application for expanded access to flotetuzumab and for MacroGenics to supply flotetuzumab for single patient use.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: