Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07528417

Evaluation of Antibiotic Prophylaxis in Myelodysplastic Syndromes and Acute Myeloid Leukemia (MYELO-CAN:ABX)

Myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) are serious, life-changing blood cancers. Patients with MDS and AML commonly experience complications related to infection, which affect patient quality-of-life and can sometimes lead to hospitalization or death. The investigators will conduct a randomized controlled trial to evaluate the effectiveness and safety of levofloxacin (antibiotic) in MDS and AML patients to safely reduce the risk of infection. In this study 50% of patients will be randomized (like a flip of a coin) to receive levofloxacin and the other 50% will receive usual care (control). The primary objective of the trial is to demonstrate the feasibility of a pragmatic pilot trial necessary to inform our planned phase 3 trial. Additionally, the investigators will monitor both groups of patients to see if the investigators improve the risk and/or severity of infection. Levofloxacin is commonly used in other clinical settings but has not been studied in patients with MDS or AML receiving outpatient chemotherapy (ie, chemotherapy that can be given from clinic, rather than a hospital).

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Myeldysplastic Syndrome (MDS) Acute Myeloid Leukemia Agranulocytosis Bone Marrow Diseases Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Leukocyte Disorders Leukopenia MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET) Myelodysplastic Syndromes Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neutropenia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

STUDY OBJECTIVES: The primary objective of this trial is to demonstrate the feasibility of a pragmatic pilot trial necessary to inform our planned phase 3 trial. TRIAL DESIGN: The investigators will conduct a 75-patient multicentre randomized open-label pilot feasibility trial evaluating levofloxacin versus usual care in patients diagnosed with myelodysplastic syndrome and acute myeloid leukemia receiving outpatient therapy. The intervention group will be levofloxacin 500mg orally daily over the 90-day trial period. Patients will take the levofloxacin daily regardless of their neutrophil count. The control group will be usual care and routine antibiotic prophylaxis is not permitted. OUTCOMES: Our primary outcome will assess the feasibility of a large, multicentre trial of antibiotic prophylaxis in patients with MDS and AML at risk for infectious complications. Our primary measure of feasibility will be the ability to enroll a median of 1 patient per site per month (10 patients / month when all sites are active). SITES AND DURATION: The investigators will initially enroll patients from 10-15 sites across Canada. The expected duration of enrollment is 2 years. SIGNIFICANCE: The trial will evaluate the feasibility of studying antibiotic prophylaxis to optimize supportive care and minimize disease-related complications in patients with MDS and AML. If antibiotic prophylaxis reduces infectious complications, the results of the trial will represent a paradigm shift in how outpatients with MDS and AML are supported and will directly impact practice throughout the world. The initial infrastructure established from this feasibility study will be leveraged to create platform trial infrastructure that will function as a patient-centred learning health system to advance knowledge and improve outcomes for patients with MDS and AML.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Master platform inclusion criteria:

  • Age ≥ 18 years
  • Diagnosis of myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasm, or acute myeloid leukemia

MYELO-CAN ABX inclusion criteria:

  • Initiation of hypomethylating agent-based chemotherapy

Exclusion criteria

Master platform exclusion criteria:

  • Participant is deemed unlikely to survive >30 days (as determined by clinical team)
  • Participant unable to provide informed consent

MYELO-CAN ABX exclusion criteria:

  • Fever/infection within 1 month of chemotherapy initiation
  • C-difficile infection within 12 months of chemotherapy initiation
  • Known sensitivity/allergy to fluoroquinolones
  • History of tendon disorders related to fluoroquinolone administration
  • Seizure disorder
  • Myasthenia gravis
  • Pregnancy and/or breastfeeding

Treatment and study plan

Levofloxacin

Drug

This group will receive Levofloxacin 500mg orally daily over the 90-day trial period. Patients will take the levofloxacin daily regardless of their neutrophil count.

Usual Care

Other

This group will receive usual care. Routine antibiotic prophylaxis is not permitted.

Primary outcomes

  1. Patient enrollment feasibility

    Time frame: 2 years

    Our primary measure of feasibility will be the ability to enroll a median of 1 patient per site per month (10 patients / month when all sites are active).

Secondary outcomes

  1. Ability to consent 30% of eligible patients

    Time frame: 2 years

    The consent rate to be adequate if 30% of eligible patients are enrolled.

  2. Protocol adherence

    Time frame: 2 years

    Protocol adherence to be acceptable provided that 80% of all intended medication doses per patient are administered

  3. Off-protocol prophylaxis antibiotic use

    Time frame: 2 years

    Off-protocol prophylaxis antibiotic use acceptable if <10% in the control arm

  4. Outcome completion

    Time frame: 2 years

    Outcome completion is adequate if 90% of outcomes are completed

  5. Risk of infection

    Time frame: 2 years

    The risk of infection sufficient if the infectious complication event rate (primary outcome of the phase III trial) is >30%.

Other outcomes

  1. Frequency of febrile neutropenia

    Time frame: 2 years

    Measure and report the frequency of febrile neutropenia and calculate the mean and median number of febrile neutropenic events per patient.

  2. Frequency of hospitalizations due to infection

    Time frame: 2 years

    Measure the frequency of hospitalizations due to infection and calculate the mean and median number of infection-related hospitalizations per patient.

  3. Number of deaths due to infection

    Time frame: 2 years

    Record the number of deaths due to infection.

  4. Frequency of chemotherapy delays

    Time frame: 3 months

    Measure the frequency of chemotherapy delays of ≥1 week. Calculate the mean and median number of ≥1-week chemotherapy cycle delays per patient.

  5. Frequency of chemotherapy cycles with dose reductions

    Time frame: 3 months

    Measure the frequency of chemotherapy cycles with dose reductions and calculate the mean and median number of chemotherapy cycles with dose reductions per patient.

Study contacts

Contact information is provided by the study sponsor or research team.

Brett Houston, MD, PhD

CONTACT

[email protected]

204-787-8552

Nora Choi, MSc

CONTACT

[email protected]

204-787-8552

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Official study title

Evaluation of Antibiotic Prophylaxis Among Outpatients With Myelodysplastic Syndrome and Acute Myeloid Leukemia: a Multicenter Pilot Trial

Acronym: MYELO-CAN:ABX

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 14, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.