Phase IB/II of CPX-351 for Relapse Prevention in AML

Exclusion Criteria

• •Prior allogeneic transplant
• •Previous cumulative anthracycline (doxorubicin equivalent) dose equal to or greater than 345 mg/m2, and for patients with prior mediastinal XRT, anthracycline dose equal to or greater than 295 mg/m2
• •Acute promyelocytic leukemia \[t(15;17)\]
• •If patient is unable to sign informed consent due to any serious medical condition, laboratory abnormality or psychiatric illness
• •Patients with evidence of uncontrolled current myocardial impairment (e.g. unstable ischemic heart disease, uncontrolled arrhythmia, symptomatic valvular dysfunction not controlled on medical therapy, uncontrolled hypertensive heart disease, and uncontrolled congestive heart failure)
• •History of Wilson's disease or other copper-related disorders
• •History of allergic reactions attributed to compounds of similar composition to cytarabine and daunorubicin or liposomal products
• •History of other malignancies, except:
• •* Malignancy treated with curative intent and with no known active disease present for ≥ 3 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician.
• •* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
• •* Adequately treated carcinoma in situ without evidence of disease.
• •Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia
• •Known active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV).
• •Subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, hepatitis C antibody, must have a negative polymerase chain reaction (PCR) result for the respective disease before enrollment. Those who are PCR positive will be excluded.
• •Any uncontrolled active systemic infection.
• •Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk.
• •Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization.
• •Known CNS involvement by leukemia
• •Erythema multiforme, toxic epidermal necrolysis, or Stevens-Johnson syndrome
• •Lactating or pregnant.
• •Unwilling or unable to participate in all required study evaluations and procedures.
• •Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations).
• •Currently active, clinically significant hepatic impairment (≥ moderate hepatic impairment according to the Child Pugh classification (class B or C))