RecruitingPhase 1NCT06514261

Testing the Combination of an Anti-Cancer Drug, Iadademstat, With Other Anti-Cancer Drugs (Venetoclax and Azacitidine) for Treating AML

Phase 1 Trial of Iadademstat in Combination With Venetoclax and Azacitidine in Patients With Treatment Naive AML


Sponsor

National Cancer Institute (NCI)

Enrollment

45 participants

Start Date

Dec 18, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial tests safety, side effects and best dose of iadademstat with azacitidine and venetoclax for the treatment of patients with acute myeloid leukemia (AML) who have not received treatment (treatment naive). Chemotherapy drugs, such as iadademstat and azacitidine work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving iadademstat with azacitidine and venetoclax may be safe and tolerable in treating patients with treatment naive AML.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a new drug called iadademstat (an LSD1 inhibitor) to the standard combination of venetoclax and azacitidine can improve outcomes for older or less fit patients with newly diagnosed intermediate or high-risk AML (acute myeloid leukemia). **You may be eligible if...** - You are 18 or older and have been newly diagnosed with intermediate or high-risk AML (excluding APL) - You have not received prior AML treatment (except hydroxyurea) - You are physically able to swallow oral medications and weigh at least 50 kg - Your physical performance is adequate (ECOG 0-2) - Your liver, kidney, and heart function meet the required thresholds **You may NOT be eligible if...** - You have been previously treated for AML - You have APL (M3 type AML) - You have serious heart, liver, or kidney conditions beyond acceptable ranges - You are pregnant or breastfeeding - You have uncontrolled serious infection 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

DRUGAzacitidine

Given IV or SC

PROCEDUREBiospecimen Collection

Undergo collection of blood samples

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDUREBuccal Swab

Undergo buccal swab

DRUGIadademstat

Given PO

DRUGVenetoclax

Given PO


Locations(4)

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT06514261


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