Dalbavancin for Childhood Leukemia

Recruiting in Palo Alto (17 mi)

Overseen byJoshua Wolf, MBBS

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: St. Jude Children's Research Hospital

No Placebo Group

Trial Summary

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

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.

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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.

See 6 more

Treatment Details

Interventions

Dalbavancin (Anti-infective)

Trial OverviewThe 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

1Treatment groups

Experimental Treatment

Group I: q28 days dalbavancin plus fluoroquinoloneExperimental Treatment2 Interventions

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