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NCT04716452 · ClinicalTrials.gov registry record · Phase 1
Study of C6 Ceramide NanoLiposome (CNL) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
A Phase 1 study of Acute Myeloid Leukemia, in Relapse and Acute Myeloid Leukemia Refractory, sponsored by Keystone Nano.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT04716452: Recruiting Phase 1 study of Acute Myeloid Leukemia, in Relapse and Acute Myeloid Leukemia Refractory, sponsored by Keystone Nano.
NCT04716452 is a Phase 1 study of Acute Myeloid Leukemia, in Relapse and Acute Myeloid Leukemia Refractory that is actively recruiting participants, run by Keystone Nano. The registered enrollment target is 15 participants, below the 59-participant average among 16 other Acute Myeloid Leukemia, in Relapse trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04716452, a Phase 1 study of Acute Myeloid Leukemia, in Relapse and Acute Myeloid Leukemia Refractory, is actively recruiting participants, sponsored by Keystone Nano.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
The study objective is to evaluate patient safety for patients with refractory and relapsed AML being treated with Ceramide NanoLiposome (CNL) .
Primary Outcome
Dose Limiting Toxicities within the first cycle of CNL monotherapy. See section 13.5 of Protocol for the complete list of Dose Limiting Toxicities
Conditions Studied
Interventions
- DRUG Ceramide NanoLiposome (Ceraxa)
Study Locations (1)
Virginia
- University of Virginia Cancer Center - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2025-10-01 |
| Est. Completion | 2026-11-30 |
| Phase | Phase 1 |
What NCT04716452 shows while recruiting
NCT04716452 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 59-participant average among 16 other Acute Myeloid Leukemia, in Relapse trials with a reported enrollment target (75% lower).
The record links to 3 conditions, with Acute Myeloid Leukemia, in Relapse appearing as the primary indexed condition, and to 1 intervention - of which Ceramide NanoLiposome (Ceraxa) is the first listed.
NCT04716452 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT04716452 about?
NCT04716452 is a clinical study titled "Study of C6 Ceramide NanoLiposome (CNL) in Patients With Relapsed/Refractory Acute Myeloid Leukemia". The study objective is to evaluate patient safety for patients with refractory and relapsed AML being treated with Ceramide NanoLiposome (CNL) .
What is the current status of trial NCT04716452?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2025-10-01. Estimated completion is 2026-11-30.
What conditions does trial NCT04716452 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory, Refractory/Relapse Acute Myeloid Leukemia.
What interventions are being tested in trial NCT04716452?
The interventions under investigation include: Ceramide NanoLiposome (Ceraxa) (DRUG).
Who is sponsoring clinical trial NCT04716452?
This trial is sponsored by Keystone Nano, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04716452 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Myeloid Leukemia, in Relapse
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Where NCT04716452's enrollment target sits among peer trials
15 16th of 16 the lowest of 16 other Acute Myeloid Leukemia, in Relapse trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia, in Relapse trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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