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NCT06810583 · ClinicalTrials.gov registry record · Phase 1

A Prospective Trial of Dalbavancin-Based Prophylaxis in Children and Adolescents With High-Risk Leukemia

A Phase 1 study of Acute Myeloid Leukemia and Leukemia, sponsored by St. Jude Children's Research Hospital.

Recruiting
Registry status
Phase 1
Development phase
29
Enrollment target
1
Study location

NCT06810583 is a Phase 1 study of Acute Myeloid Leukemia and Leukemia that is actively recruiting participants, run by St. Jude Children's Research Hospital. The registered enrollment target is 29 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06810583, a Phase 1 study of Acute Myeloid Leukemia and Leukemia, is actively recruiting participants, sponsored by St. Jude Children's Research Hospital.

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

Study Summary

This is a single-arm pilot clinical trial evaluating dalbavancin-based prophylaxis in children and adolescents with acute myeloid leukemia or relapsed lymphoblastic leukemia receiving myelosuppressive chemotherapy. Primary objective: \- To estimate the rate of bacterial bloodstream infection in pediatric patients with AML or relapsed ALL undergoing chemotherapy receiving dalbavancin-based prophylaxis Secondary objectives: * To describe the population pharmacokinetics of every 28 days dalbavancin up to 12 weeks in pediatric patients with AML or relapsed ALL undergoing chemotherapy * To describe the tolerability of every 28 days dalbavancin prophylaxis in pediatric patients with AML or relapsed ALL undergoing chemotherapy * To describe the acceptability of every 28 days dalbavancin prophylaxis in pediatric patients with AML or relapsed ALL undergoing chemotherapy * To estimate the rates of likely bacterial infections, Clostridioides difficile infection, and febrile neutropenia in pediatric patients receiving dalbavancin-based prophylaxis

Conditions Studied

Acute Myeloid Leukemia Leukemia Lymphoblastic Leukemia in Children

Interventions

  • DRUG Dalbavancin
  • DRUG Fluoroquinolone (either ciprofloxacin or levofloxacin at the discretion of the treating clinician)

Study Locations (1)

Tennessee

  • St. Jude Children's Research Hospital - Memphis

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2025-05-22
Est. Completion 2031-09
Phase Phase 1

Sponsor

St. Jude Children's Research Hospital

410 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06810583

The ClinicalTrials.gov registry entry for NCT06810583 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 29 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 (75% lower). The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Dalbavancin is the first listed.

NCT06810583 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.

Frequently Asked Questions

What is clinical trial NCT06810583 about?

NCT06810583 is a clinical study titled "A Prospective Trial of Dalbavancin-Based Prophylaxis in Children and Adolescents With High-Risk Leukemia". This is a single-arm pilot clinical trial evaluating dalbavancin-based prophylaxis in children and adolescents with acute myeloid leukemia or relapsed lymphoblastic leukemia receiving myelosuppressive chemotherapy. Primary objective: \- To estimate the rate of bacterial bloodstream infection in pe...

What is the current status of trial NCT06810583?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2025-05-22. Estimated completion is 2031-09.

What conditions does trial NCT06810583 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia, Leukemia, Lymphoblastic Leukemia in Children.

What interventions are being tested in trial NCT06810583?

The interventions under investigation include: Dalbavancin (DRUG), Fluoroquinolone (either ciprofloxacin or levofloxacin at the discretion of the treating clinician) (DRUG).

Who is sponsoring clinical trial NCT06810583?

This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06810583 being conducted?

This trial has 1 study location across Tennessee. 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.