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RecruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
Up to 25 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests dalbavancin, an antibiotic, to help prevent bacterial blood infections during chemotherapy. It is for people age 25 or younger with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) that has come back. The study also looks at how the body handles the drug and how well patients tolerate taking it every 28 days for up to 12 weeks.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 25 or younger when joining the study.
  • Getting treatment for AML or ALL that has come back at St. Jude. Treatment must be expected to cause very low levels of infection-fighting white blood cells for more than 7 days.
  • Expected to receive care at St. Jude for at least 56 days after joining.
  • Female participants age 9 or older must have a recorded negative pregnancy test before getting the study drug.

Who can't join

  • Allergy to vancomycin, dalbavancin, teicoplanin, levofloxacin, or ciprofloxacin. A vancomycin infusion reaction that was not a severe allergic reaction does not count.
  • Within the past 6 months, had an infection or carried harmful bacteria resistant to vancomycin and either ciprofloxacin or levofloxacin.
  • Have long QT syndrome, a heart rhythm condition, or another medical reason that rules out dalbavancin or fluoroquinolone antibiotics.
  • Have a suspected or confirmed active bacterial infection.
  • The study doctor believes joining would be too risky or that you cannot complete the study requirements.
  • Expected to live less than 28 days.
  • Certain liver-related blood test levels are at least 3 times the normal upper limit for age, or the kidney filtering test result (eGFR) is below 30.
  • Pregnant or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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, within the prior 6 months * 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 sites (1)

TN