Study of C6 Ceramide NanoLiposome (CNL) in Patients With Relapsed/Refractory Acute Myeloid Leukemia (NCT04716452) | Clinical Trial Compass
RecruitingPhase 1
Study of C6 Ceramide NanoLiposome (CNL) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
United States15 participantsStarted 2025-10-01
Plain-language summary
The study objective is to evaluate patient safety for patients with refractory and relapsed AML being treated with Ceramide NanoLiposome (CNL) .
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. ECOG performance status must be ≤2
✓. Peripheral white blood cell (WBC) count \<30,000/µL. For cyto-reduction, the following are allowed to reduce WBC count to \< 30,000/µL:
✓. Adequate organ function as evidenced by the following laboratory findings:
Exclusion criteria
✕. 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.
✕
What they're measuring
1
Number of Patients with Dose Limiting Toxicities as defined in Protocol Section 13.5
Timeframe: At the end of the the first cycle of administration (each cycle is 28 days)
2
Number of Patients with Adverse Events
Timeframe: Through study completion, an average of 24 weeks
3
Severity of Adverse Events
Timeframe: Through study completion, an average of 24 weeks
4
Duration of Adverse Events
Timeframe: Length of Adverse Events as measured in days, measured through study completion, an average of 24 weeks
5
Duration of therapy
Timeframe: Through study completion, an average of 24 weeks
6
Dose Levels achieved during study
Timeframe: Through study completion, an average of 24 weeks
7
Concentration Max (C Max)
Timeframe: Through cycle one, 28 days (each cycle is 28 days)
. 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).
Timeframe: Through cycle one, 28 days (each cycle is 28 days)
9
Half Life of Study Drug
Timeframe: Through cycle one, 28 days (each cycle is 28 days)
10
Study Drug Clearance
Timeframe: Through cycle one, 28 days (each cycle is 28 days)
11
Ratio of C16/C24 Ceramides
Timeframe: After one cycle of therapy (Day 28)
12
Clinical Response - Complete Response
Timeframe: After Cycle Two (56 days)
13
Clinical Response - Complete Response with Incomplete Hematologic Recovery (CRi)