Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06448013
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-06-03
Brief Title:
A Phase I Study Investigating the Combination of the Menin Inhibitor Ziftomenib With Venetoclax and Gemtuzumab in Pediatric Patients With Acute Myeloid Leukemia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase I Study Investigating the Combination of the Menin Inhibitor Ziftomenib With Venetoclax and Gemtuzumab in Pediatric Patients With Acute Myeloid Leukemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
To find the recommended dose of ziftomenib in combination with gemtuzumab ozogamicin and venetoclax that can be given to pediatric participants who have relapsed or refractory AML or MPAL
Detailed Description:
Primary Objectives
- To determine the safety tolerability and recommended Phase II dose RP2D of ziftomenib in combination with gemtuzumab ozogamicin and venetoclax for pediatric participants with acute myeloid leukemia AML
Secondary Objectives
To determine the preliminary assessment of efficacy by overall response OR including complete remission CR CR with incomplete blood count recovery and partial remission overall survival OS event-free survival EFS and duration of response DOR of pediatric participants treated with this combination
To determine time to first response and time to best response of pediatric participants treated with this combination
Exploratory Objective
- To evaluate molecular and cellular markers that may be predictive of antitumor activity andor resistance
- To determine the safety tolerability and recommended Phase II dose RP2D of ziftomenib in combination with gemtuzumab ozogamicin and venetoclax for pediatric participants with acute myeloid leukemia AML
Secondary Objectives
To determine the preliminary assessment of efficacy by overall response OR including complete remission CR CR with incomplete blood count recovery and partial remission overall survival OS event-free survival EFS and duration of response DOR of pediatric participants treated with this combination
To determine time to first response and time to best response of pediatric participants treated with this combination
Exploratory Objective
- To evaluate molecular and cellular markers that may be predictive of antitumor activity andor resistance
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-04821 | OTHER | NCI-CTRP Clinical Registry | None |