NCT07528417

Brief Summary

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).

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
20mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 14, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2028

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

April 7, 2026

Last Update Submit

April 20, 2026

Conditions

Myeldysplastic Syndrome (MDS)MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET)Acute Myeloid Leukemia

Keywords

LevofloxacinRandomized Controlled TrialMyelodysplastic SyndromeMyeloproliferative NeoplasmAcute Myeloid LeukemiaNeutropenia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Ability to consent 30% of eligible patients

    2 years

  • Protocol adherence

    2 years

  • Off-protocol prophylaxis antibiotic use

    2 years

  • Outcome completion

    2 years

  • Risk of infection

    2 years

Other Outcomes (5)

  • Frequency of febrile neutropenia

    2 years

  • Frequency of hospitalizations due to infection

    2 years

  • Number of deaths due to infection

    2 years

  • +2 more other outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL
Drug: Levofloxacin

Control group

ACTIVE COMPARATOR
Other: Usual Care

Interventions

LevofloxacinDRUG

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.

Intervention group
Usual CareOTHER

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

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Diagnosis of myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasm, or acute myeloid leukemia
  • \. Initiation of hypomethylating agent-based chemotherapy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

MeSH Terms

Conditions

Myeloproliferative DisordersLeukemia, Myeloid, AcuteMyelodysplastic SyndromesNeutropenia

Interventions

Levofloxacin

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsAgranulocytosisLeukopeniaCytopeniaLeukocyte Disorders

Intervention Hierarchy (Ancestors)

OfloxacinFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Brett Houston, MD, PhD

CONTACT

204-787-8552bhouston@cancercare.mb.ca

Nora Choi, MSc

CONTACT

204-787-8552nchoi@hsc.mb.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized controlled pilot trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2026

First Posted

April 14, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

April 30, 2028

Last Updated

April 22, 2026

Record last verified: 2026-04

Locations

CA(1)