Ignite Creation Date:
2024-05-06 @ 6:20 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05622591
Status:
WITHDRAWN
Last Update Posted:
2023-12-08
First Post:
2022-11-08
Brief Title:
ELU001 in Pediatric Subjects Who Have Relapsed andor Refractory CBFA2T3-GLIS2-positive AML
Sponsor:
Elucida Oncology
Organization:
Elucida Oncology
Study Overview
Official Title:
Dose Escalation Study to Evaluate the Safety and Tolerability of ELU001 in Pediatric Patients Who Have Relapsed andor Refractory CBFA2T3GLIS2 Positive Acute Myeloid Leukemia
Status:
WITHDRAWN
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of Funding - no safety issue with Drug Company Permanently Closed
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Pediatric AML
Brief Summary:
This research study was planned to focus on a rare type of acute myeloid leukemia with the subtype CBFA2T3GLIS2 that overexpresses folate receptor alpha FRĪ± a protein on the surface of leukemia cells that has relapsed or is refractory Relapse means the cancer has come back after treatment Refractory means the cancer does not respond to treatment
Detailed Description:
This study was planned as a Dose Escalation Safety Study to identify the maximum tolerated dose MTD andor the recommended phase 2 dose RP2D This study will also evaluate the tolerability of ELU001
ELU001 is not a drug approved by the FDA Food and Drug Administration yet
ELU001 is not a drug approved by the FDA Food and Drug Administration yet
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