This study tests a new treatment for adults with a type of blood cancer called acute myeloid leukemia (AML). The study looks at how well two different doses of a drug called L-Annamycin work with another drug called Cytarabine. Participants must have AML that has returned (relapsed) or not responded (refractory) after one treatment.
The study has two parts. In Part A, doctors will figure out the best dose of L-Annamycin. In Part B, they will use that dose to compare it with a placebo (a substance with no active drug) in more people. Participants are randomly placed into different groups, and some will receive the placebo instead of L-Annamycin.
- The study includes two parts, with each part testing different doses.
- Participants receive intravenous (IV) infusions over several days.
- The study involves multiple centers and will include up to 312 adults with AML.
Participants should discuss any potential risks with their doctor before joining.