Study on CPX-351 and Glasdegib for Newly Diagnosed Acute Myelogenous Leukemia with MDS-Related Changes or Therapy-Related AML

Inclusion Criteria

• Adults aged 18 or older with newly diagnosed AML related to MDS changes or therapy-related AML.
• Must not have received any prior treatment for AML, except for managing high white blood cell counts.
• Good overall health with a performance status score of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Adequate heart, liver, and kidney function as determined by specific medical tests.
• No unstable heart conditions, such as recent heart attacks or uncontrolled heart failure.
• Ability to understand and sign a consent form, or have a representative do so if necessary.
• Women and men of childbearing potential must agree to use two forms of birth control or abstain from sex during the study and for 120 days after the last dose.
• Certain medications to manage high white blood cell counts are allowed for up to 7 days after starting the study treatment.

Exclusion Criteria

• Previous treatment with CPX-351 or Glasdegib.
• Prior treatment for AML, except for managing high white blood cell counts.
• Active leukemia in the brain or testicles.
• History of certain neurological disorders, such as seizures or strokes.
• Heart rhythm issues with a QTcF interval over 450 ms.
• Recent severe heart conditions, like a heart attack in the past year.
• Known copper metabolism disorders, like Wilson's disease.
• Digestive disorders affecting absorption.
• Other active cancers requiring treatment, except for certain skin cancers or cervical cancer.
• Known HIV or active hepatitis B or C infections.
• Uncontrolled infections or fungal infections.
• Pregnant or breastfeeding women, or those planning to conceive during the study.
• Severe medical conditions that could interfere with the study.
• Use of other experimental treatments.
• For those with prior anthracycline exposure, the total lifetime dose must not exceed a certain limit.