RecruitingPhase 1NCT06357182

Iadademstat in Combination With Azacitidine and Venetoclax in Treating Newly Diagnosed Acute Myeloid Leukemia

A Phase Ib Investigation of the LSD1 Inhibitor Iadademstat (ORY-1001) in Combination With Azacitidine and Venetoclax in Newly Diagnosed AML


Sponsor

OHSU Knight Cancer Institute

Enrollment

24 participants

Start Date

Aug 22, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial tests the safety, side effects, and best dose of iadademstat when given together with azacitidine and venetoclax in treating patients with newly diagnosed acute myeloid leukemia (AML). Iadademstat inhibits the LSD1 protein and may lead to inhibition of cell growth in LSD1-overexpressing cancer cells. Chemotherapy drugs, such as 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, tolerable and/or effective in treating patients with newly diagnosed AML who cannot undergo intensive chemotherapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a three-drug combination — iadademstat (a new oral drug), azacitidine, and venetoclax — for patients with newly diagnosed acute myeloid leukemia (AML) who are not able to tolerate standard intensive chemotherapy, often because of age or other health conditions. **You may be eligible if...** - You are 18 or older with a newly diagnosed AML (confirmed by bone marrow testing), with intermediate or high-risk genetic features - You are not a candidate for intensive chemotherapy due to age (75+) or a significant health condition such as heart problems, reduced lung function, or reduced kidney function - Patients 18–74 years old may also qualify if they have specific comorbidities that make standard chemotherapy unsafe - Your blood counts, liver function, and kidney function (creatinine clearance ≥60 mL/min) meet required levels - You are able to swallow oral medications - You agree to use contraception and provide bone marrow samples **You may NOT be eligible if...** - You have previously been treated for AML - You have a known allergy to any of the study drugs - You weigh less than 50 kg - You have an active serious infection, uncontrolled bleeding disorder, or recent stroke - You have poorly controlled diabetes (HbA1c ≥8%) or uncontrolled high blood pressure - You are pregnant or breastfeeding - You are HIV positive on certain antiretroviral treatments that interfere with study medications 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAzacitidine

Given SC

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDUREEchocardiography Test

Undergo ECHO

DRUGIadademstat

Given PO

PROCEDUREMultigated Acquisition Scan

Undergo MUGA

OTHERQuestionnaire Administration

Ancillary study

DRUGVenetoclax

Given PO


Locations(1)

OHSU Knight Cancer Institute

Portland, Oregon, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06357182


Related Trials