A Phase II Study of CPX-351 in Younger Patients < 60 Years Old With Secondary Acute Myeloid Leukemia
This phase II trial studies how well liposome-encapsulated daunorubicin-cytarabine (CPX-351) works in treating patients with secondary acute myeloid leukemia who are younger than 60 years old. Drugs used in chemotherapy, such as CPX-351, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
• Newly diagnosed:
‣ Therapy-related acute myeloid leukemia (AML)
⁃ AML with antecedent myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML)
⁃ AML with MDS-related changes (as per World Health Organization \[WHO\])
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
• Plasma creatinine =\< 1.5 x upper limit of normal (ULN)
• Total bilirubin \< 2.0 mg/dL
• Serum alanine aminotransferase and aspartate aminotransferase \< 3 x ULN
• Left ventricular ejection fraction by echocardiogram or multiple-gated acquisition \>= 50%
• Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
• Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to enrollment and commit to two forms of birth control
• Men must use a latex condom during any sexual contact with women of childbearing potential
• Willing to adhere to protocol specific requirements
• Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure