Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT05360160
Status:
RECRUITING
Last Update Posted:
2025-10-23
First Post:
2022-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I-II Study Investigating the All-Oral Combination of the Menin Inhibitor SNDX-5613 With Decitabine/Cedazuridine (ASTX727) and Venetoclax in Acute Myeloid Leukemia (SAVE)
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
A Phase I-II Study Investigating the All Oral Combination of the Menin Inhibitor SNDX-5613 With Decitabine/Cedazuridine (ASTX727) and Venetoclax in Acute Myeloid Leukemia (SAVE)
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Part 1b of this clinical research study is to find the highest tolerable dose of SNDX-5613 that can be given in combination with ASTX727 (a combination of the drugs decitabine/cedazuridine) and venetoclax for patients with acute myeloid leukemia (AML) or those with a mixed phenotype acute leukemia with a myeloid phenotype (MPAL).
Part 2 of this study is to learn if the dose of study drugs found in Part 1b can help to control AML/MPAL
Part 2 of this study is to learn if the dose of study drugs found in Part 1b can help to control AML/MPAL
Detailed Description:
Primary Objectives:
Phase Ib
• To determine the safety, tolerability and recommended phase II dose (RP2D) of SNDX-5613 in combination with oral decitabine/cedazuridine (ASTX727) and venetoclax for patients with acute myeloid leukemia (AML).
Phase II
• To assess the efficacy of SNDX-5613 in combination with ASTX727 and venetoclax for patients with AML.
Secondary Objectives
• To assess overall survival, event-free survival and duration of response.
Exploratory Objectives
• To evaluate molecular and cellular markers that may be predictive of antitumor activity and/or resistance.
Phase Ib
• To determine the safety, tolerability and recommended phase II dose (RP2D) of SNDX-5613 in combination with oral decitabine/cedazuridine (ASTX727) and venetoclax for patients with acute myeloid leukemia (AML).
Phase II
• To assess the efficacy of SNDX-5613 in combination with ASTX727 and venetoclax for patients with AML.
Secondary Objectives
• To assess overall survival, event-free survival and duration of response.
Exploratory Objectives
• To evaluate molecular and cellular markers that may be predictive of antitumor activity and/or resistance.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2022-03312 | OTHER | NCI-CTRP-Clinical Trial Reporting Registry | View |