Dalbavancin for Childhood Leukemia

Overseen By Joshua Wolf, MBBS

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: St. Jude Children's Research Hospital

Must be taking: Dalbavancin

Must not be taking: Vancomycin, Ciprofloxacin, Levofloxacin

Disqualifiers: Allergy, Long QT syndrome, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

29 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What is the purpose of this trial?

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

Research Team

Joshua Wolf, MBBS

Principal Investigator

St. Jude Children's Research Hospital

Eligibility Criteria

This trial is for children and adolescents with high-risk leukemia, specifically acute myeloid leukemia (AML) or relapsed lymphoblastic leukemia (ALL), who are undergoing strong chemotherapy. Participants must be able to receive dalbavancin-based prophylaxis.

Inclusion Criteria

I am 25 years old or younger.

Expected to receive care at St. Jude for at least 56 days following enrollment on the protocol

I am being treated for AML or ALL at St. Jude and expected to have very low white blood cell counts.

Exclusion Criteria

Allergy to vancomycin, dalbavancin, teicoplanin, levofloxacin or ciprofloxacin (Not including non-anaphylactic vancomycin infusion reaction)

I have had an infection resistant to vancomycin and either ciprofloxacin or levofloxacin.

I have been diagnosed with long QT syndrome.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive dalbavancin every 28 days in combination with fluoroquinolone for up to 3 doses (12 weeks)

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and infection rates

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Dalbavancin

Trial Overview The study tests if dalbavancin can prevent bloodstream infections in young patients with AML or relapsed ALL during chemotherapy. It's a single-arm pilot trial where all participants get the same treatment, including an antibiotic regimen every 28 days up to 12 weeks.

Participant Groups

Group I: q28 days dalbavancin plus fluoroquinolone Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+