Phase IB/II Study of CPX-351 for Preventing Relapse in Acute Myeloid Leukemia (AML)

Inclusion Criteria

• Adults over 18 years old who have been newly diagnosed with AML.
• Must be in complete remission (CR) or partial remission with some blood count recovery (CRh).
• Must have received initial treatment with standard chemotherapy or a combination of hypomethylating agents and venetoclax, for up to 6 cycles or no more than one year.
• Able to start the study treatment within 3 months of achieving remission.
• Have AML that is either newly developed or secondary, including AML with changes related to myelodysplasia, confirmed by tests.
• Not eligible for a bone marrow transplant for various reasons, such as health status, personal choice, or other medical conditions.
• Heart function must be adequate, with a pumping ability of 50% or more.
• Liver and kidney function must be within acceptable limits based on specific blood tests.
• Must have a performance status score of 3 or less, indicating the ability to perform daily activities with some limitations.
• Women who cannot become pregnant or have undergone procedures to prevent pregnancy, or women of childbearing potential with a negative pregnancy test.
• Agree to use effective birth control methods during the study and for at least 6 months after the last dose.

Exclusion Criteria

• Have had a previous bone marrow transplant.
• Have received a high cumulative dose of certain chemotherapy drugs.
• Have a specific type of leukemia called acute promyelocytic leukemia.
• Unable to provide informed consent due to serious medical or psychiatric conditions.
• Have uncontrolled heart problems, such as severe heart disease or arrhythmias.
• Have a history of Wilson's disease or other copper-related disorders.
• Have allergies to similar drugs used in the study.
• Have had other cancers, unless treated successfully and inactive for at least 3 years.
• Have unresolved side effects from previous cancer treatments, except for hair loss.
• Have known bleeding disorders or active infections with hepatitis B or C.
• Have any uncontrolled infections or serious medical conditions that could affect safety or study results.
• Have significant heart disease or recent heart attacks.
• Have leukemia that has spread to the central nervous system.
• Have severe skin reactions or conditions like Stevens-Johnson syndrome.
• Are pregnant or breastfeeding.
• Unwilling or unable to participate in all study procedures and evaluations.
• Unable to understand the study's purpose and risks or provide informed consent.
• Have significant liver impairment according to specific medical classifications.