The study objective is to evaluate patient safety for patients with refractory and relapsed AML being treated with Ceramide NanoLiposome (CNL) .
Signed informed consent is obtained prior to conducting any study-specific screening procedures.
Willing and able to understand the nature of this study and to comply with the study and follow-up procedures.
Age and Disease: ≥ 18 years of age with refractory or relapsed AML
Eastern Cooperative Oncology Group (ECOG) performance status must be ≤2.
Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmias not well controlled with medication, myocardial infarction within the previous 6 months before registration, or psychiatric illness/social situations that would limit compliance with study requirements.
Patients may not be receiving any other concurrent investigational agents during study treatment and not for at least within one week prior to starting study treatment.
Since the teratogenic potential of this combination is currently unknown, females who are pregnant or lactating are excluded.
History of any other malignancies within the preceding 12 months before registration with the exception of in-situ cancer, non-muscle invasive bladder cancer, non-metastatic prostate cancer, basal or squamous cell skin cancer.
Keystone Nano, Inc
Lead sponsor
University of Virginia
Collaborator
Milton S. Hershey Medical Center
Collaborator
National Cancer Institute (NCI)
Collaborator