Actively Recruiting
Study of C6 Ceramide NanoLiposome (CNL) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Led by Keystone Nano, Inc · Updated on 2026-03-31
15
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
Sponsors
K
Keystone Nano, Inc
Lead Sponsor
U
University of Virginia
Collaborating Sponsor
AI-Summary
What this Trial Is About
The study objective is to evaluate patient safety for patients with refractory and relapsed AML being treated with Ceramide NanoLiposome (CNL) .
CONDITIONS
Official Title
Study of C6 Ceramide NanoLiposome (CNL) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
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Signed informed consent is obtained prior to conducting any study-specific screening procedures.
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Willing and able to understand the nature of this study and to comply with the study and follow-up procedures.
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Age and Disease: ≥ 18 years of age with refractory or relapsed AML
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.
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.
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).
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Eastern Cooperative Oncology Group (ECOG) performance status must be ≤2.
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ECOG performance status must be ≤2
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Peripheral white blood cell (WBC) count <30,000/µL. For cyto-reduction, the following are allowed to reduce WBC count to < 30,000/µL:
- hydroxyurea is allowed during screening and through the end of Cycle,
- cytarabine is allowed during screening but not after registration and should be limited 1 g/m2 or less from time of consent to registration.
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Adequate organ function as evidenced by the following laboratory findings:
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN) or < 3 x ULN for patients with Gilbert-Meulengracht Syndrome
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN if not attributed to leukemia, or ≤ 5 x ULN if attributed to leukemia
- Creatinine clearance > 60 mL/min.
You will not qualify if you...
Patients meeting any of the following criteria are ineligible for study entry:
- 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.
- 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.
- Evidence of isolated extramedullary disease.
- Acute Promyelocytic Leukemia.
- AML with active central nervous system (CNS) involvement (as determined by study investigator).
- Severe infection requiring treatment that would interfere with study drug(s) or study participation in the opinion of the treating investigator.
- 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.
- All adverse reactions from prior therapy must have recovered to Grade ≤ 1 or acceptable baseline per treating investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
J
James H Adair, Ph.D.
CONTACT
B
Bernadette M Adair, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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