This study is for people aged 18 to 80 with acute myeloid leukemia (AML) that has come back or didn't respond to previous treatment with venetoclax and a hypomethylating agent (HMA) like azacitidine or decitabine. It is testing a new combination of medicines: mitoxantrone, venetoclax, and azacitidine. Venetoclax works by blocking a protein called Bcl-2, which helps cancer cells survive. Researchers want to find the safest and most effective dose of mitoxantrone when given with venetoclax and azacitidine. They will also look at how many participants respond to the treatment and the number of serious side effects. The study plans to enroll 30 participants.

Study design

This is an open-label, Phase 1 study, meaning both you and your doctors will know which treatments you are receiving. It will involve a dose-finding stage followed by expansion cohorts.

What's involved

You will receive venetoclax, azacitidine, and mitoxantrone. The mitoxantrone will be given intravenously (into a vein) on days 1-4 of each cycle. Treatment will continue until the maximum tolerated dose is found, up to 5 cycles if needed.

Compensation

Not stated in the trial record.

Follow-up

Researchers will monitor your response to treatment and any side effects from the start of treatment up to one year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.