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

NCT04716452 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-03-31

No results posted yet for this study

Summary

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

Conditions

  • Acute Myeloid Leukemia, in Relapse
  • Acute Myeloid Leukemia, Refractory
  • Refractory/Relapse Acute Myeloid Leukemia

Interventions

DRUG

Ceramide NanoLiposome (Ceraxa)

Ceramide NanoLiposome will be given by IV twice a week. The dose, which is based on body size, will be increased for the next group of patients if the first group of patients tolerates that dose and it will decrease for the next group if they do not tolerate the dose.

Sponsors & Collaborators

  • University of Virginia

    collaborator OTHER

  • Milton S. Hershey Medical Center

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Keystone Nano, Inc

    lead INDUSTRY

Principal Investigators

  • Daniel Vlock, MD · Keystone Nano, Inc

  • Christopher Prior, Ph.D. · Keystone Nano

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-09-30
Completion
2026-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04716452 on ClinicalTrials.gov