Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT05360160
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
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.
Study:
NCT05360160
Study Brief:
Protocol Section:
NCT05360160