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New treatment option for Acute Myeloid Leukemia, in Relapse
Official title Study of C6 Ceramide NanoLiposome (CNL) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT04716452
What this study is testing
What is Ceramide NanoLiposome (Ceraxa)?
Ceramide NanoLiposome (Ceraxa) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute myeloid leukemia, in relapse.
Also referred to as Ceramide NanoLiposome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study objective is to evaluate patient safety for patients with refractory and relapsed AML being treated with Ceramide NanoLiposome (CNL) .
- Phase 1: an early, usually small safety study
- Time commitment: about 6 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 Refractory AML: Patients who fail to achieve a complete remission (CR) or a...
- Eastern Cooperative Oncology Group (ECOG) performance status must be ≤2.
- ECOG performance status must be ≤2
You likely can't join if
- 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...
- Patients may not be receiving any other concurrent investigational agents during study treatment and not for at least within one week prior to...
- 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...
- Life-threatening illnesses other than AML, uncontrolled medical conditions or organ system dysfunction that, in the Investigator's opinion, could...
See the full eligibility 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 Refractory AML: Patients who fail to achieve a complete remission (CR) or a complete remission with incomplete count recovery (CRi) after one or more...
- 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:
- 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.
- 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.
- 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...
- 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...
- 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...
- All adverse reactions from prior therapy must have recovered to Grade ≤ 1 or acceptable baseline per treating investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.