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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: Recruiting Phase 1 study of Acute Myeloid Leukemia and Leukemia, sponsored by St. Jude Children's Research Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Proportion of evaluable participants with bacterial bloodstream infection with 95% confidence intervals
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2025-05-22 |
| Est. Completion | 2031-09 |
| Phase | Phase 1 |
What NCT06810583 shows while recruiting
NCT06810583 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (75% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT06810583's enrollment target sits among peer trials
29 211th of 306 higher than 95 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia 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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