[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100417497":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":30,"locations":40,"responsibleParty":63,"collaborators":65,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":35,"enrollmentInfo":84,"targetDuration":35,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":43,"whyStopped":35,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Keystone Nano, Inc","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Open Label Administration of Ceramide NanoLiposome","EXPERIMENTAL","Ceramide NanoLiposome will be administered by Intravenous Dosing twice per week in accordance with the protocol relative to dose escalation. There is no placebo group or arm of the study.",[13],"Drug: Ceramide NanoLiposome (Ceraxa)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Ceramide NanoLiposome (Ceraxa)","Ceramide NanoLiposome will be given by IV twice a week. The dose, which is based on body size, will be increased for the next group of patients if the first group of patients tolerates that dose and it will decrease for the next group if they do not tolerate the dose.",[9],[21],"Ceramide NanoLiposome",[23,26],{"name":24,"affiliation":5,"role":25},"Daniel Vlock, MD","STUDY_DIRECTOR",{"name":27,"affiliation":28,"role":29},"Christopher Prior, Ph.D.","Keystone Nano","STUDY_CHAIR",[31,37],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"James H Adair, Ph.D.","CONTACT","814-360-4654",null,"jadair@pendreabio.com",{"name":38,"role":33,"phone":35,"phoneExt":35,"email":39},"Bernadette M Adair, BS","ba8387@gmail.com",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"University of Virginia Cancer Center","RECRUITING","Charlottesville","Virginia","22903","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-78.47668,38.02931,{"lat":53,"lon":52},[56,60],{"name":57,"role":33,"phone":58,"phoneExt":35,"email":59},"Cory Caldwell","434-297-4182","CLCALMCRCs@uvahealth.org",{"name":61,"role":62,"phone":35,"phoneExt":35,"email":35},"Michael Keng, MD","PRINCIPAL_INVESTIGATOR",{"type":64,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR",[66,69,71],{"name":67,"class":68},"University of Virginia","OTHER",{"name":70,"class":68},"Milton S. Hershey Medical Center",{"name":72,"class":73},"National Cancer Institute (NCI)","NIH","100417497","phase-1-study-of-c6-ceramide-nanoliposome-cnl-in-patients-with-relapsedrefractory-acute-myeloid-leukemia-100417497",false,"NCT04716452","Study of C6 Ceramide NanoLiposome (CNL) in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","Phase I Study of C6 Ceramide NanoLiposome (CNL) in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia (RR-AML)","KNAN2001","Inclusion Criteria:\n\n1. Signed informed consent is obtained prior to conducting any study-specific screening procedures.\n2. Willing and able to understand the nature of this study and to comply with the study and follow-up procedures.\n3. Age and Disease: ≥ 18 years of age with refractory or relapsed AML\n\n   Refractory AML: Patients who fail to achieve a complete remission (CR) or a complete remission with incomplete count recovery (CRi) after one or more ines of AML directed therapy.\n\n   Relapsed AML: Patients who achieved a complete remission (CR) or a complete remission with incomplete count recovery (CRi) with one or more prior lines of AML directed therapy but then developed a relapse of AML.\n\n   Note: Patients are eligible even if they have not received intensive induction chemotherapy but have been treated with other AML directed therapy like hypomethylating agents (azacitidine, decitabine).\n4. Eastern Cooperative Oncology Group (ECOG) performance status must be ≤2.\n5. ECOG performance status must be ≤2\n6. Peripheral white blood cell (WBC) count \\\u003C30,000\u002FµL. For cyto-reduction, the following are allowed to reduce WBC count to \\\u003C 30,000\u002FµL:\n\n   * hydroxyurea is allowed during screening and through the end of Cycle,\n   * cytarabine is allowed during screening but not after registration and should be limited 1 g\u002Fm2 or less from time of consent to registration.\n7. Adequate organ function as evidenced by the following laboratory findings:\n\n   * Total bilirubin ≤ 1.5 × upper limit of normal (ULN) or \\\u003C 3 x ULN for patients with Gilbert-Meulengracht Syndrome\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN if not attributed to leukemia, or ≤ 5 x ULN if attributed to leukemia\n   * Creatinine clearance \\> 60 mL\u002Fmin.\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria are ineligible for study entry:\n\n1. 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\u002Fsocial situations that would limit compliance with study requirements.\n2. 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.\n3. Since the teratogenic potential of this combination is currently unknown, females who are pregnant or lactating are excluded.\n4. 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.\n5. Life-threatening illnesses other than AML, uncontrolled medical conditions or organ system dysfunction that, in the Investigator's opinion, could compromise the patient's safety or put the study outcomes at risk.\n6. Evidence of isolated extramedullary disease.\n7. Acute Promyelocytic Leukemia.\n8. AML with active central nervous system (CNS) involvement (as determined by study investigator).\n9. Severe infection requiring treatment that would interfere with study drug(s) or study participation in the opinion of the treating investigator.\n10. Past Hematopoietic stem cell transplant (HSCT) with graft vs host disease, immunosuppression other than low dose prednisone (10 mg) (or equivalent does of another immunosuppressant) within the 4 weeks before registration.\n11. All adverse reactions from prior therapy must have recovered to Grade ≤ 1 or acceptable baseline per treating investigator.","ALL","18 Years",{"count":85,"type":86},15,"ESTIMATED","INTERVENTIONAL",[89],"PHASE1","The study objective is to evaluate patient safety for patients with refractory and relapsed AML being treated with Ceramide NanoLiposome (CNL) .",[92,93,94],"Acute Myeloid Leukemia, in Relapse","Acute Myeloid Leukemia, Refractory","Refractory\u002FRelapse Acute Myeloid Leukemia",[96,97,98,99,100,101,102,103,104,105,106],"Acute Myeloid Leukemia","Relapsed","Refractory","Ceramide","AML","NanoLiposome","Relapsed\u002FRefratory Acute Myleoid Leukemia","NanoLiposomes","Safety","CNL","Ceraxa","2026-03-26",{"date":109,"type":110},"2026-03-31","ACTUAL",{"date":112,"type":110},"2025-10-01",{"date":114,"type":86},"2026-11-30",{"name":5,"class":6},1]