CPX-351 for the Treatment of Secondary Acute Myeloid Leukemia in Patients Younger Than 60 Years Old

Korábbi kezelés

• Prior treatment of AML
• Prior anthracycline exposure > 368 mg/m\^2 of daunorubicin or equivalent
• Subject with concurrent severe and/or uncontrolled medical or psychiatric conditions that in the opinion of the investigator may impair the participation in the study or the evaluation of safety and/or efficacy

Más betegség

• Uncontrolled other malignancy
• Cardiovascular disease resulting in heart failure (New York Heart Association class III or IV), unstable angina (angina symptoms at rest), or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months
• Hypersensitivity to cytarabine, daunorubicin, or liposomal drugs
• Known active HIV infection
• Known history of active hepatitis B or C infection
• Pre-existing liver disease (e.g. cirrhosis, chronic hepatitis B or C, nonalcoholic steatohepatitis, sclerosing cholangitis)
• Evidence of ongoing, uncontrolled systemic infection
• History of Wilson disease or other copper-handling disorders
• Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug

Egyéb

• Known clinically active central nervous system (CNS) leukemia
• Core-binding factor leukemia
• Acute promyelocytic leukemia
• Pregnant or breastfeeding women

• 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