RecruitingPhase 2NCT06773208

A Study of Azacitidine and Venetoclax in People With Acute Myeloid Leukemia (AML)

A Phase 2 Study of Azacitidine and Venetoclax to Treat Acute Myeloid Leukemia Patients With Measurable Residual Disease Before an Allogeneic Stem Cell Transplant


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

30 participants

Start Date

Jan 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to find out if azacitidine and venetoclax are an effective treatment approach to get rid of or lower measurable residual disease (MRD) in people with acute myeloid leukemia (AML) who have received standard chemotherapy and are planning to have an allogeneic hematopoietic stem cell transplant (HSCT). Allogeneic HSCT, sometimes called a bone marrow transplant, involves receiving healthy blood-forming cells (stem cells) from a donor in order to replace the patient's immune system and lower the chances of the disease returning (relapse).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of azacitidine (a low-intensity chemotherapy) and venetoclax (a targeted drug that helps cancer cells die) as a first-line treatment for adults with newly diagnosed acute myeloid leukemia (AML), a blood cancer, who are not suitable for intensive chemotherapy. **You may be eligible if...** - You are 18 or older with a newly confirmed diagnosis of AML (not the APL subtype) - You are not a candidate for intensive chemotherapy - You have not received prior treatment for AML - You are willing to comply with study visits and procedures **You may NOT be eligible if...** - You have acute promyelocytic leukemia (APL) or relapsed/refractory AML - You have previously been treated with a venetoclax-containing regimen - You have blast crisis of chronic myeloid leukemia - Your bone marrow has 5% or more abnormal blast cells from another condition - You have other serious health conditions that could interfere with treatment 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 (AZC)

75 mg/m2 daily, on days 1-7, given IV or SC

DRUGVenetoclax

Venetoclax 400 mg orally daily on days 1-28


Locations(7)

Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (All Protocol Activities)

Rockville Centre, New York, United States

View Full Details on ClinicalTrials.gov

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NCT06773208


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