Charlottesville, VANCT04716452Now EnrollingIRB Ready

Acute Myeloid Leukemia, in Relapse Clinical Trial in Charlottesville, VA

Access cutting-edge acute myeloid leukemia, in relapse treatment through this clinical trial at a research site in Charlottesville. Study-provided care at no cost to qualified participants.

Sponsored by Keystone Nano, Inc

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Expert Care in Charlottesville

Access acute myeloid leukemia, in relapse specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related acute myeloid leukemia, in relapse treatment provided free

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Check if you qualify for this acute myeloid leukemia, in relapse clinical trial in Charlottesville, VA

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Why Participate?

  • No-Cost Study Care

  • Local to Charlottesville

    Convenient for VA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Charlottesville site if eligible
  4. 4Begin participation

About This Acute Myeloid Leukemia, in Relapse Study in Charlottesville

The study objective is to evaluate patient safety for patients with refractory and relapsed AML being treated with Ceramide NanoLiposome (CNL) .

Sponsor: Keystone Nano, Inc

Who Can Participate

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 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).
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.

Exclusion Criteria

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Charlottesville?

Yes, this clinical trial (NCT04716452) has an active research site in Charlottesville, VA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Acute Myeloid Leukemia, in Relapse Treatment Options in Charlottesville, VA

If you're searching for acute myeloid leukemia, in relapse treatment options in Charlottesville, VA, this clinical trial (NCT04716452) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Charlottesville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced acute myeloid leukemia, in relapse specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all acute myeloid leukemia, in relapse clinical trials near you to find additional studies recruiting in your area.

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