Levofloxacin for Blood Cancers

(MYELO-CAN:ABX Trial)

BH
NC
Overseen ByNora Choi, MSc
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Manitoba
Must be taking: Hypomethylating agents
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if levofloxacin, an antibiotic, can reduce infections in people with myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML), two serious blood cancers. Infections pose significant challenges for these patients, affecting their quality of life and sometimes leading to hospitalization. Half of the participants will receive levofloxacin, while the other half will continue with their usual care to compare results. Suitable candidates for this trial have been diagnosed with MDS or AML and are starting a specific type of chemotherapy that can be administered outside of a hospital. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering a chance to contribute to important findings.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if 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 levofloxacin is likely to be safe for patients with MDS and AML?

Research has shown that levofloxacin is generally safe for patients with blood cancers like AML (acute myeloid leukemia). One study used a short course of levofloxacin as a preventive measure for AML patients, and it was well-tolerated without significantly increasing antibiotic resistance. Another study found that while levofloxacin did not affect the occurrence of fever with low white blood cell count, it was safely used alongside other AML treatments.

Levofloxacin is a commonly used antibiotic, indicating its general safety. However, specific safety information for patients receiving outpatient chemotherapy for MDS (myelodysplastic syndromes) or AML is still being collected. Patients should always consult their healthcare provider for personalized advice.12345

Why do researchers think this study treatment might be promising?

Levofloxacin is unique because it's an antibiotic being explored for use in blood cancers, which is an unconventional approach. Unlike traditional chemotherapy, which directly attacks cancer cells, levofloxacin may help prevent infections in patients with compromised immune systems due to cancer or its treatment. Researchers are excited about its potential to improve patient outcomes by reducing infection-related complications, which are common in blood cancer patients.

What evidence suggests that levofloxacin might be an effective treatment for blood cancers?

Research has shown that levofloxacin can help lower the risk of infections in patients receiving chemotherapy for blood cancers like AML (acute myeloid leukemia). One study found that patients who took levofloxacin had fewer infections, with a rate of 26.1%, compared to 52.0% in those who did not take it. Another study reported that 82.8% of patients with fever due to low white blood cell counts became fever-free within 72 hours after using levofloxacin. However, some studies found no effect on febrile neutropenia, a condition characterized by fever and low white blood cells. In this trial, participants in the intervention group will receive levofloxacin to evaluate its effectiveness in preventing infections during cancer treatment, while the control group will not receive it. Overall, levofloxacin appears promising in preventing infections during cancer treatment.23467

Are You a Good Fit for This Trial?

This trial is for adults (18+) starting outpatient chemotherapy with a diagnosis of myelodysplastic syndrome, related blood disorders, or acute myeloid leukemia. People can't join if they are pregnant/breastfeeding, have certain infections or allergies to antibiotics like levofloxacin, muscle/nerve issues, seizures, or are very unwell.

Inclusion Criteria

I am 18 years old or older.
I have started chemotherapy with a hypomethylating agent.
I have been diagnosed with MDS, MDS/MPN, or AML.

Exclusion Criteria

I have myasthenia gravis.
Known sensitivity/allergy to fluoroquinolones
Pregnancy and/or breastfeeding
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive levofloxacin 500mg orally daily or usual care over the 90-day trial period

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Levofloxacin

Trial Overview

The study compares giving the antibiotic levofloxacin versus usual care (no routine preventive antibiotics) in people with MDS or AML receiving outpatient chemotherapy. Participants are randomly assigned to either group to see if levofloxacin safely lowers infection risk.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Intervention groupExperimental Treatment1 Intervention
Group II: Control groupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials
628
Recruited
209,000+

Citations

Effectiveness of levofloxacin in the induction of chemotherapy ...

When used as antibiotic prophylaxis, fluoroquinolones may help decrease infections in patients with FN, but inculcating this as standard practice is still ...

Levofloxacin to Prevent Bacterial Infection in Patients with ...

Levofloxacin to prevent bacterial infection in patients with acute myeloid leukemia treated by azacitidine and Venetoclax: a study from the Dataml Registry.

Efficacy of oral levofloxacin monotherapy against low-risk FN ...

Outcomes of FN therapy. FN was improved by oral LVFX treatment in 24 (82.8%) patients (Table 3). Seventeen of 24 patients became afebrile within 72 hours and ...

Effectiveness of levofloxacin in the induction ...

In adult cancer patients undergoing rigorous chemotherapy, antibiotic prophylaxis has demonstrated decreased bacteraemia and enhanced survival [ ...

Levofloxacin to Prevent Bacterial Infection in Patients With ...

This study assessed levofloxacin prophylaxis in venetoclax-azacitidine treatment for acute myeloid leukemia. No impact on febrile neutropenia was observed.

Levofloxacin to Prevent Bacterial Infection in Patients with ...

A short course of levofloxacin as primary prophylaxis in AML patients treated with VEN-AZA was well tolerated, seemed to have no impact on microbial resistance.

Levofloxacin prophylaxis in pediatric oncology and ... - PMC

A single-center retrospective study based in Italy compared the outcomes of levofloxacin versus ciprofloxacin prophylaxis in allo-HSCT pediatric patients with ...