Study of C6 Ceramide NanoLiposome (CNL) in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Launched by KEYSTONE NANO, INC · Jan 15, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called C6 Ceramide NanoLiposome (CNL) to see if it can help improve the effectiveness of standard cancer treatments for patients with relapsed or refractory Acute Myeloid Leukemia (AML). "Relapsed" means that the cancer returned after treatment, while "refractory" means that the cancer didn't respond to previous treatments. The trial is currently not recruiting participants, but it aims to include adults aged 18 and older who have this specific type of leukemia and meet certain health criteria.

To participate, patients need to give their consent and be able to follow the study guidelines. They should also have their white blood cell count under control and show that their organs are functioning well. However, patients with certain serious health conditions or those currently receiving other investigational treatments won't be eligible. If accepted, participants can expect to receive the new treatment alongside standard therapies and will be monitored closely throughout the process. This trial could provide important information on how CNL might enhance the effectiveness of existing cancer treatments for AML.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed informed consent is obtained prior to conducting any study-specific screening procedures.
• • 2. Willing and able to understand the nature of this study and to comply with the study and follow-up procedures.
• • 3. Age and Disease: ≥ 18 years of age with refractory or relapsed AML
• • Refractory AML: Patients who fail to achieve a complete remission (CR) after one line of AML directed therapy
• • Relapsed AML: Patients who achieved a complete remission (CR) 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).
• • 4. Eastern Cooperative Oncology Group (ECOG) performance status must be ≤2
• • 5. Peripheral white blood cell (WBC) count \<30,000/µL. For cyto-reduction, hydroxyurea is allowed during screening and through Cycle 2, Day 3 to reduce WBC count to \< 30,000 µL.
• 6. 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) ≤ 2.5 × ULN
• • Creatinine clearance \> 60 mL/min
• • 7. QT-interval corrected according to Fridericia's formula (QTcF) \< 450 ms on one electrocardiogram (ECG) at screening
• Exclusion Criteria:
• Patients meeting any of the following criteria are ineligible for study entry:
• • 1. 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.
• • 2. Patients may not be receiving any other concurrent investigational agents, or have received any investigational agent within one week of registration.
• • 3. Since the teratogenic potential of this combination is currently unknown, females who are pregnant or lactating are excluded.
• • 4. History of any other malignancies within the preceding 12 months before registration with the exception of in-situ cancer, non-muscle invasive bladder cancer, prostate, basal or squamous cell skin cancer
• • 5. 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
• • 6. Evidence of isolated extramedullary disease
• • 7. Acute Promyelocytic Leukemia or AML with active central nervous system (CNS) involvement
• • 8. Untreated severe (in the opinion of the treating investigator) infection
• • 9. Active and uncontrolled infection with HIV (viral load is detectable by PCR)
• • 10. Active infection with Hepatitis B virus (HbSAg positive or PCR with detectable viral load) or Hepatitis C virus (viral load detectable by PCR).
• • 11. Past Hematopoietic stem cell transplant (HSCT) with active graft vs host disease, immunosuppression other than low dose prednisone (5 mg), or calcineurin inhibitors within the 4 weeks before registration