Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2026-01-04 @ 3:42 AM
Study NCT ID:
NCT02483312
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-01
First Post:
2015-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of (Interleukin-12) IL-12 in Patients With Acute Myelogenous Leukemia (AML)
Sponsor:
University Health Network, Toronto
Organization:
Study Overview
Official Title:
Phase I Study of Autologous Acute Myelogenous Leukemia (AML) Cells Containing Lentivirus Engineering Expression of IL-12
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
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:
This is a phase 1 study (the first stage in testing a new treatment to see how safe and tolerable the treatment is) which will include patients with acute myeloid leukemia (AML) that has either returned or has a more than a 70% chance of coming back and cannot have a bone marrow transplant.
This study will see whether modifying a patient's AML cells to produce IL-12 and giving it back to the patient is safe and useful in patients with AML that cannot have bone marrow transplants.
This study will see whether modifying a patient's AML cells to produce IL-12 and giving it back to the patient is safe and useful in patients with AML that cannot have bone marrow transplants.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| OZM-068 | OTHER | Ozmosis Research Inc. | View |