Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06376162
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-03-28
Brief Title:
Ziftomenib in Combination With Chemotherapy for Children With RelapsedRefractory Acute Leukemia
Sponsor:
LLS PedAL Initiative LLC
Organization:
LLS PedAL Initiative LLC
Study Overview
Official Title:
A Phase 1 Trial of Menin-inhibitor Ziftomenib in Combination With Chemotherapy for Children With RelapsedRefractory KMT2A-rNUP98-rNPM1-m Acute Leukemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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 primary objective of the study is to determine the recommended phase 2 dose RP2D of ziftomenib in combination with chemotherapy FLA in children with relapsed or refractory KMT2A-r NUP98-r or NPM1-m acute leukemia based on safety and pharmacokinetics PK
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-505262-28-00 | CTIS | None | None |