This study is investigating a new all-oral combination of medicines for Acute Myeloid Leukemia (AML) or a related blood cancer called MPAL. The medicines being tested are SNDX-5613, ASTX727 (which combines decitabine and cedazuridine), and venetoclax. The first part of the study aims to find the safest and most effective dose of SNDX-5613 when given with ASTX727 and venetoclax. The second part will then check how well this combination works to control AML/MPAL. You may be able to join if you are 12 years or older, have newly diagnosed AML/MPAL and cannot receive intense chemotherapy, or if your AML/MPAL has returned or is not responding to treatment, and you have specific genetic markers (KMT2Ar, NUP98r, or NPM1c). The study hopes to determine the best dose and assess how effective this treatment is.

Study design

This is an interventional study with a planned enrollment of 43 participants. It is designed in two parts: Part 1b to find the right dose, and Part 2 to assess effectiveness.

What's involved

Not specified in the trial record.

Compensation

Not stated in the trial record.

Follow-up

The primary endpoint, establishing the recommended dose, is measured through study completion, an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.