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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called dalbavancin (an antibiotic) in children and adolescents with specific types of leukemia (a blood cancer). The goal is to determine if dalbavancin can prevent bacterial infections during chemotherapy, a time when the immune system is weak. Researchers aim to learn more about how the body processes the drug and how well patients tolerate it. Children and teens with either acute myeloid leukemia or relapsed lymphoblastic leukemia undergoing chemotherapy might be suitable for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to contribute to groundbreaking research.

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.

Is there any evidence suggesting that dalbavancin is likely to be safe for children and adolescents with leukemia?

Research has shown that dalbavancin is generally safe for children. Past studies found no serious side effects linked to dalbavancin in children, and hearing tests revealed no issues. Some studies found that children have about 30% less dalbavancin in their bodies compared to adults, but it remains safe. Dalbavancin is already used to treat serious skin infections, indicating its safety. However, since this trial is in an early stage, the researchers are primarily focused on understanding its safety and determining the right dose, so they will closely monitor participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Dalbavancin is unique because it's an antibiotic that's being tested for its potential to help treat childhood leukemia, specifically to prevent infections during treatment. Unlike other standard treatments for leukemia that focus solely on chemotherapy, dalbavancin works by targeting bacterial infections, which can be a serious complication for kids undergoing cancer treatment. Researchers are excited about dalbavancin because it is administered once every 28 days, potentially offering a more convenient and less frequent dosing schedule compared to other antibiotics. This can make it easier for young patients and their families to manage during an already challenging time.

What evidence suggests that dalbavancin might be an effective treatment for childhood leukemia?

Research shows that dalbavancin can help prevent serious infections in children with leukemia. Previous studies have found that dalbavancin is safe and effective for treating complex infections caused by certain bacteria in children. It has also been used to shorten hospital stays, indicating effective infection management. In this trial, participants will receive dalbavancin every 28 days alongside standard fluoroquinolone prophylaxis. Reducing infections is vital for children with leukemia because chemotherapy weakens their immune systems. These findings offer hope that dalbavancin could protect against bacterial infections during cancer treatment. ^{1 4 6 7 8}

Who Is on the Research Team?

Joshua Wolf, MBBS

Principal Investigator

St. Jude Children's Research Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06810583

A Prospective Trial of Dalbavancin-Based Prophylaxis in ...

This is a single-arm pilot clinical trial evaluating dalbavancin-based prophylaxis in children and adolescents with acute myeloid leukemia or relapsed ...

2.

academic.oup.com

academic.oup.com/jac/article/79/8/2062/7704656

Off-label use of dalbavancin in children: a case series

Dalbavancin was a safe, effective and convenient alternative in selected paediatric patients with complicated non-ABSSSI infections caused by Gram-positive ...

3.

stjude.org

stjude.org/care-treatment/clinical-trials/daphne-high-risk-leukemia.html

Dalbavancin to Prevent Infections in High-Risk Leukemia

This clinical trial studies dalbavancin to prevent infection in children and teens with acute myeloid leukemia or relapsed acute lymphoblastic leukemia.

4.

trial.medpath.com

trial.medpath.com/clinical-trial/091e93b6a1da1a12/nct06810583-dalbavancin-prophylaxis-children-high-risk-leukemia

A Prospective Trial of Dalbavancin-Based Prophylaxis in ...

Primary outcome will be rate of bacterial bloodstream infection during the first 56 days, with comparison to historical control receiving vancomycin-based ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10814822/

Real-World Use of Dalbavancin for Treatment of Soft Tissue ...

The use of dalbavancin was safe, feasible and also effective in shortening the hospital stay in children and adolescents.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5468484/

Dalbavancin Pharmacokinetics and Safety in Children 3 ...

Dalbavancin pediatric dosing that matched adult exposure was identified. Overall, dalbavancin was well tolerated in our study population. Keywords: dalbavancin, ...

7.

journals.lww.com

journals.lww.com/pidj/fulltext/2023/03000/the_safety_and_efficacy_of_dalbavancin_and_active.6.aspx

The Safety and Efficacy of Dalbavancin and Active...

Previous pediatric trials reported no serious adverse events (SAEs) or deaths related to dalbavancin treatment. In addition, audiograms showed no evidence of ...

8.

mdpi.com

mdpi.com/2079-6382/14/2/121

Bridging the Gap: A Systematic Review with Expert Opinion ...

Dalbavancin exposure was 30% lower in pediatric patients compared to adults. In acute bacterial skin and skin structure infections (ABSSSIs), the overall ...