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

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Myeloid Leukemia; MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET); Myeldysplastic Syndrome (MDS)
• Intervention / Treatment: Drug: Levofloxacin; Other: Usual Care

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Brett Houston, MD, PhD; Phone Number: 204-787-8552; Email: bhouston@cancercare.mb.ca
• Study Contact Backup: Name: Nora Choi, MSc; Phone Number: 204-787-8552; Email: nchoi@hsc.mb.ca

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • CancerCare Manitoba
      • Contact: Brett Houston, MD, PhD; Phone Number: 204-787-1103; Email: bhouston@cancercare.mb.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Master platform inclusion criteria:

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

MYELO-CAN ABX inclusion criteria:

1. Initiation of hypomethylating agent-based chemotherapy

Exclusion Criteria:

Master platform exclusion criteria:

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

MYELO-CAN ABX exclusion criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group	Drug: Levofloxacin; 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.
Active Comparator: Control group	Other: Usual Care; This group will receive usual care. Routine antibiotic prophylaxis is not permitted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient enrollment feasibility	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).	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability to consent 30% of eligible patients	The consent rate to be adequate if 30% of eligible patients are enrolled.	2 years
Protocol adherence	Protocol adherence to be acceptable provided that 80% of all intended medication doses per patient are administered	2 years
Off-protocol prophylaxis antibiotic use	Off-protocol prophylaxis antibiotic use acceptable if <10% in the control arm	2 years
Outcome completion	Outcome completion is adequate if 90% of outcomes are completed	2 years
Risk of infection	The risk of infection sufficient if the infectious complication event rate (primary outcome of the phase III trial) is >30%.	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of hospitalizations due to infection	Measure the frequency of hospitalizations due to infection and calculate the mean and median number of infection-related hospitalizations per patient.	2 years
Number of deaths due to infection	Record the number of deaths due to infection.	2 years
Frequency of chemotherapy delays	Measure the frequency of chemotherapy delays of ≥1 week. Calculate the mean and median number of ≥1-week chemotherapy cycle delays per patient.	3 months
Frequency of chemotherapy cycles with dose reductions	Measure the frequency of chemotherapy cycles with dose reductions and calculate the mean and median number of chemotherapy cycles with dose reductions per patient.	3 months
Frequency of febrile neutropenia	Measure and report the frequency of febrile neutropenia and calculate the mean and median number of febrile neutropenic events per patient.	2 years

Collaborators and Investigators

• Sponsor: University of Manitoba

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Acute Myeloid Leukemia; Randomized Controlled Trial; Levofloxacin; Myeloproliferative Neoplasm; Myelodysplastic Syndrome; Neutropenia
• Additional Relevant MeSH Terms: Cytopenia; Neoplasms; Neoplasms by Histologic Type; Leukocyte Disorders; Hematologic Diseases; Leukemia, Myeloid; Bone Marrow Diseases; Leukemia; Leukopenia; Agranulocytosis; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Myeloproliferative Disorders; Neutropenia; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Ofloxacin; Levofloxacin
• Other Study ID Numbers: CHI-001-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No