Recruiting
Phase 1

Dalbavancin

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT06810583

Conditions

Leukemia

Acute Myeloid Leukemia

Lymphoblastic Leukemia in Children

Eligibility Criteria

Sex: All

Age: 0 - 25

Healthy Volunteers: Not accepted

Interventions

Dalbavancin

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

Study Details

Brief 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

Leukemia

Acute Myeloid Leukemia

Lymphoblastic Leukemia in Children

Study ID

NCT06810583

Start date

May 22, 2025

Status verified date

Feb, 2026

Completion date

Sep, 2031

Anticipated

Primary completion date

Sep, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 25

Healthy Volunteers: Not accepted

Inclusion 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.

Exclusion Criteria:

  • 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
  • Other absolute contraindication to administration of fluoroquinolone antibiotics or dalbavancin
  • Participant is pregnant or breastfeeding a child

Study Design

Enrollment

29 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: q28 days dalbavancin plus fluoroquinolone

Dalbavancin given at standard treatment doses once every 28 days in combination with standard of care fluoroquinolone (ciprofloxacin or levofloxacin) prophylaxis.

Interventions

Dalbavancin

3 doses of q28 days dalbavancin (12 weeks).

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

28 days dalbavancin plus fluoroquinolone (either ciprofloxacin or levofloxacin at the discretion of the treating clinician) for up to 3 doses (12 weeks).

Primary outcome measure

  • Bacterial bloodstream infection [ Time Frame: Day 56 ]

Central Contacts and Locations

Central contacts

Joshua Wolf, MBBS

8662785833referralinfo@stjude.org

Locations

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Rohith Jesudas, MBBS

866-278-5833referralinfo@stjude.org

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Feb 3, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-02-03.