RecruitingPhase 1NCT06429449

Mitoxantrone for Venetoclax Resistant Acute Myeloid Leukemia


Sponsor

University of Colorado, Denver

Enrollment

30 participants

Start Date

Jul 21, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open label, phase 1 study for AML subjects with relapsed or refractory disease or subjects in morphologic remission with MRD+ after first line therapy with venetoclax+HMA. A preliminary dose-finding cohort will be followed by 3 expansion cohorts.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called mitoxantrone can overcome resistance to venetoclax — a targeted cancer therapy — in people with acute myeloid leukemia (AML) whose cancer has stopped responding to venetoclax-based first-line treatment. It is examining both patients with early signs of remaining cancer and those with frank relapse. **You may be eligible if...** - You have been diagnosed with AML (excluding a specific subtype called APL) - You were previously treated with venetoclax combined with a hypomethylating agent (azacitidine or decitabine) as your first treatment - Your cancer has relapsed or did not respond adequately to that treatment - You are in generally good health and able to care for yourself (ECOG 0–2) - Your kidney, liver, and heart function are within acceptable ranges - Your heart pumps at more than 50% of normal capacity (LVEF above 50%) **You may NOT be eligible if...** - Your AML has spread to the brain or spinal fluid - You have significant active heart disease, including recent heart attack or severe heart failure - You have serious kidney, liver, neurological, psychiatric, or metabolic conditions unrelated to your leukemia - You are pregnant or breastfeeding 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

DRUGVenetoclax

Venetoclax attaches to a protein called Bcl-2. This protein is present in high amounts in CLL cancer cells, where it helps the cells survive for longer in the body and makes them resistant to cancer medicines. By attaching to Bcl-2 and blocking its actions, venetoclax causes the death of cancer cells and thereby slows down progression of the disease.

DRUGAzacitidine

An analog of the pyrimidine nucleoside cytidine, has effects on cell differentiation, gene expression, and deoxyribonucleic acid (DNA) synthesis and metabolism, and causes cytotoxicity.

DRUGMitoxantrone

Mitoxantrone Injection, USP (concentrate) is a synthetic antineoplastic anthracenedione for intravenous use.


Locations(1)

University of Colorado Hospital

Aurora, Colorado, United States

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NCT06429449


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