RecruitingPhase 1Phase 2NCT05360160

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)

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

Enrollment

43 participants

Start Date

Oct 14, 2022

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an all-oral combination of three cancer drugs — a menin inhibitor (SNDX-5613), a hypomethylating agent (decitabine/cedazuridine), and venetoclax — for people with acute myeloid leukemia (AML) or related blood cancers that have specific genetic features. **You may be eligible if...** - You are at least 12 years old and weigh at least 40 kg - You have been newly diagnosed with AML or a related blood cancer and are not eligible for intensive chemotherapy, OR your cancer has returned or stopped responding to prior treatment - Your cancer has a specific genetic mutation (KMT2A, NUP98, or NPM1) - Your white blood cell count is below 25,000 at enrollment (cytoreduction is allowed beforehand) - Your heart function and liver function are within acceptable ranges **You may NOT be eligible if...** - You have a type of leukemia called acute promyelocytic leukemia - You have active, uncontrolled infection - You are pregnant or breastfeeding - You have significant heart or liver problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSNDX-5613

Given by PO

DRUGVenetoclax

Given by PO

DRUGASTX727

Given by PO


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT05360160


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