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NCT04926285 · ClinicalTrials.gov registry record · Phase 1

Safety and Efficacy of Venetoclax With Escalating Doses of Omacetaxine in Patients With Acute Myeloid Leukemia Safety and Efficacy of Venetoclax With Escalating Doses of Omacetaxine in Patients With Acute Myeloid Leukemia (AML)

A Phase 1 study, sponsored by University of Illinois at Chicago.

Completed
Registry status
Phase 1
Development phase
6
Enrollment target

NCT04926285: Completed Phase 1 study, sponsored by University of Illinois at Chicago.

NCT04926285 is a Phase 1 study that has completed, run by University of Illinois at Chicago. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04926285, a Phase 1 study, has completed, sponsored by University of Illinois at Chicago.

COMPLETED
Registry status
Phase 1
Development phase
6 participants
Enrollment target

Study Summary

This will be a single arm, open label Phase Ib dose-escalation study of the combination of VEN and OM, conducted using an innovative Bayesian Optimal Interval-design, to find the MTD in participants with AML failing treatment with venetoclax-containing regimens. Treatment plan will consist of an induction phase, followed by a consolidation phase if applicable.

Primary Outcome

Subjects will be monitored for dose limiting toxicities until Day 42 before escalation to the next dose may occur

Interventions

  • DRUG Venetoclax
  • DRUG Omacetaxine

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2022-06-21
Est. Completion 2025-02-06
Phase Phase 1
University of Illinois at Chicago

430 total trials

What the finished NCT04926285 record still lists

NCT04926285 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 2 interventions - of which Venetoclax is the first listed.

NCT04926285 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04926285 about?

NCT04926285 is a clinical study titled "Safety and Efficacy of Venetoclax With Escalating Doses of Omacetaxine in Patients With Acute Myeloid Leukemia Safety and Efficacy of Venetoclax With Escalating Doses of Omacetaxine in Patients With Acute Myeloid Leukemia (AML)". This will be a single arm, open label Phase Ib dose-escalation study of the combination of VEN and OM, conducted using an innovative Bayesian Optimal Interval-design, to find the MTD in participants with AML failing treatment with venetoclax-containing regimens. Treatment plan will consist of an ind...

What is the current status of trial NCT04926285?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2022-06-21. Estimated completion is 2025-02-06.

What interventions are being tested in trial NCT04926285?

The interventions under investigation include: Venetoclax (DRUG), Omacetaxine (DRUG).

Who is sponsoring clinical trial NCT04926285?

This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04926285's enrollment target sits among peer trials

6 1974th of 2000 higher than 12 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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Source: ClinicalTrials.gov NCT04926285, the US trial registry maintained by the National Library of Medicine. NCT04926285 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.