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NCT05558124 · ClinicalTrials.gov registry record · Phase 1

CPX-351 in Combination With Gemtuzumab Ozogamicin in Newly Diagnosed AML

A Phase 1 study of Acute Myeloid Leukemia, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Recruiting
Registry status
Phase 1
Development phase
18
Enrollment target
1
Study location

NCT05558124 is a Phase 1 study of Acute Myeloid Leukemia that is actively recruiting participants, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 18 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05558124, a Phase 1 study of Acute Myeloid Leukemia, is actively recruiting participants, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

RECRUITING
Registry status
Phase 1
Development phase
18 participants
Enrollment target
1
Study location

Study Summary

The purpose of the study is to determine the safety of combining the drugs gemtuzumab ozogamicin (GO) with CPX-351 in order to treat the disease, as well as to find the maximum tolerated dose level and recommended Phase 2 dose level of GO with a fixed dose of CPX-351.

Conditions Studied

Acute Myeloid Leukemia

Interventions

  • DRUG Vyxeos
  • DRUG Gemtuzumab Ozogamicin

Study Locations (1)

Florida

  • Moffitt Cancer Center - Tampa

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2023-02-16
Est. Completion 2027-04
Phase Phase 1

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

502 total trials

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What the Registry Record Tells You About NCT05558124

The ClinicalTrials.gov registry entry for NCT05558124 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (84% lower). The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Vyxeos is the first listed.

NCT05558124 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT05558124 about?

NCT05558124 is a clinical study titled "CPX-351 in Combination With Gemtuzumab Ozogamicin in Newly Diagnosed AML". The purpose of the study is to determine the safety of combining the drugs gemtuzumab ozogamicin (GO) with CPX-351 in order to treat the disease, as well as to find the maximum tolerated dose level and recommended Phase 2 dose level of GO with a fixed dose of CPX-351.

What is the current status of trial NCT05558124?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2023-02-16. Estimated completion is 2027-04.

What conditions does trial NCT05558124 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia.

What interventions are being tested in trial NCT05558124?

The interventions under investigation include: Vyxeos (DRUG), Gemtuzumab Ozogamicin (DRUG).

Who is sponsoring clinical trial NCT05558124?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05558124 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.