RECRUITING

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

Conditions

Leukemia Acute Myeloid Leukemia Lymphoblastic Leukemia in Children

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-06

Study Completion:2030-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06810583

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 25 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* Aged less than or equal to 25 years at enrollment * Receiving treatment for AML or relapsed ALL at St. Jude and treatment is expected to cause prolonged (\> 7 days) severe neutropenia (ANC \< 500/ml) * Expected to receive care at St. Jude for at least 56 days following enrollment on the protocol * Female participant, greater than or equal to 9 years old, has a documented negative pregnancy test prior to receipt of study drug.	* Allergy to vancomycin, dalbavancin, teicoplanin, levofloxacin or ciprofloxacin (Not including non-anaphylactic vancomycin infusion reaction) * Documented past or current infection or colonization with pathogenic bacteria resistant to vancomycin plus either ciprofloxacin or levofloxacin * Diagnosed with long QT syndrome * Any condition judged by the investigator to put the participant at high risk from participation * Suspected or proven active bacterial infection * Inability to complete requirements of participation in the study (in the opinion of the investigator) * Expected survival \<28 days * Alkaline phosphatase, alanine transferase or total bilirubin ≥ 3x upper limit of normal for age * Estimated glomerular filtration rate (EGFR) \<30 mL/minute/1.73 m2

Inclusion Criteria

Exclusion Criteria

* Aged less than or equal to 25 years at enrollment
* Receiving treatment for AML or relapsed ALL at St. Jude and treatment is expected to cause prolonged (\> 7 days) severe neutropenia (ANC \< 500/ml)
* Expected to receive care at St. Jude for at least 56 days following enrollment on the protocol
* Female participant, greater than or equal to 9 years old, has a documented negative pregnancy test prior to receipt of study drug.

* Allergy to vancomycin, dalbavancin, teicoplanin, levofloxacin or ciprofloxacin (Not including non-anaphylactic vancomycin infusion reaction)
* Documented past or current infection or colonization with pathogenic bacteria resistant to vancomycin plus either ciprofloxacin or levofloxacin
* Diagnosed with long QT syndrome
* Any condition judged by the investigator to put the participant at high risk from participation
* Suspected or proven active bacterial infection
* Inability to complete requirements of participation in the study (in the opinion of the investigator)
* Expected survival \<28 days
* Alkaline phosphatase, alanine transferase or total bilirubin ≥ 3x upper limit of normal for age
* Estimated glomerular filtration rate (EGFR) \<30 mL/minute/1.73 m2

Contacts and Locations

Study Contact

Joshua Wolf, MBBS

CONTACT

8662785833

referralinfo@stjude.org

Principal Investigator

Joshua Wolf, MBBS

PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Study Locations (Sites)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105

United States

Collaborators and Investigators

Sponsor: St. Jude Children's Research Hospital

Joshua Wolf, MBBS, PRINCIPAL_INVESTIGATOR, St. Jude Children's Research Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06

Study Completion Date2030-09

Study Record Updates

Study Start Date2025-06

Study Completion Date2030-09

Terms related to this study

Additional Relevant MeSH Terms

Leukemia
Acute Myeloid Leukemia
Lymphoblastic Leukemia in Children