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NCT06613217 · ClinicalTrials.gov registry record · Phase 1
Study of Oral PCLX-001 in R/R Acute Myeloid Leukemia
A Phase 1 study of Relapsed Adult AML, sponsored by Pacylex Pharmaceuticals.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT06613217: Recruiting Phase 1 study of Relapsed Adult AML, sponsored by Pacylex Pharmaceuticals.
NCT06613217 is a Phase 1 study of Relapsed Adult AML that is actively recruiting participants, run by Pacylex Pharmaceuticals. The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06613217, a Phase 1 study of Relapsed Adult AML, is actively recruiting participants, sponsored by Pacylex Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a dose-finding study of oral zelenirstat (PCLX-001) in patients with R/R AML. There are two parts to the study: Dose Escalation and Dose Expansion.
Primary Outcome
The recommended dose will be the dose level below that for the cohort in which maximum tolerated dose (MTD) was reached/exceeded. MTD will have been reached when 2 or more patients in a cohort experience DLT.
Conditions Studied
Interventions
- DRUG zelenirstat
Study Locations (1)
Texas
- MD Anderson Cancer Centre - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2025-03-03 |
| Est. Completion | 2026-09-01 |
| Phase | Phase 1 |
What NCT06613217 shows while recruiting
NCT06613217 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).
The record links to 1 condition, with Relapsed Adult AML appearing as the primary indexed condition, and to 1 intervention - of which zelenirstat is the first listed.
NCT06613217 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06613217 about?
NCT06613217 is a clinical study titled "Study of Oral PCLX-001 in R/R Acute Myeloid Leukemia". This is a dose-finding study of oral zelenirstat (PCLX-001) in patients with R/R AML. There are two parts to the study: Dose Escalation and Dose Expansion.
What is the current status of trial NCT06613217?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2025-03-03. Estimated completion is 2026-09-01.
What conditions does trial NCT06613217 study?
This clinical trial studies the following conditions: Relapsed Adult AML.
What interventions are being tested in trial NCT06613217?
The interventions under investigation include: zelenirstat (DRUG).
Who is sponsoring clinical trial NCT06613217?
This trial is sponsored by Pacylex Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06613217 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06613217's enrollment target sits among peer trials
35 1259th of 2000 higher than 728 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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