Myeldysplastic Syndrome (MDS)Phase 2MYELO-CAN:ABXNCT07528417
Evaluation of Antibiotic Prophylaxis in Myelodysplastic Syndromes and Acute Myeloid Leukemia (MYELO-CAN:ABX)
A Phase 2 study testing Levofloxacin in people with Myeldysplastic Syndrome (MDS) and MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET), run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeldysplastic Syndrome (MDS), MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET), Acute Myeloid Leukemia
- What is being tested?
- Levofloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2026to 30 Apr 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Master platform inclusion criteria:
- Age ≥ 18 years
- Diagnosis of myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasm, or acute myeloid leukemia
- MYELO-CAN ABX inclusion criteria:
- 1. Initiation of hypomethylating agent-based chemotherapy
Who cannot join
- 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
Show all 11Show fewer
- Known sensitivity/allergy to fluoroquinolones
- History of tendon disorders related to fluoroquinolone administration
- Seizure disorder
- Myasthenia gravis
- Pregnancy and/or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Brett Houston, MD, PhD, 204-787-1103, bhouston@cancercare.mb.ca
About this study
Official title: 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).
Read the 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.
- Conditions
- Myeldysplastic Syndrome (MDS), MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET), Acute Myeloid Leukemia
- Being tested
- Levofloxacin, Usual Care
- Keywords
- Levofloxacin, Randomized Controlled Trial, Myelodysplastic Syndrome, Myeloproliferative Neoplasm, Acute Myeloid Leukemia, Neutropenia
- Medical subject headings
- Myeloproliferative Disorders, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Usual CareOther
This group will receive usual care. Routine antibiotic prophylaxis is not permitted.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Drug: Levofloxacin |
| Control group | Active comparator | Not described Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 years
Secondary outcomes (5)
Ability to consent 30% of eligible patients
The consent rate to be adequate if 30% of eligible patients are enrolled.
Measured: 2 years
Protocol adherence
Protocol adherence to be acceptable provided that 80% of all intended medication doses per patient are administered
Measured: 2 years
Off-protocol prophylaxis antibiotic use
Off-protocol prophylaxis antibiotic use acceptable if <10% in the control arm
Measured: 2 years
Outcome completion
Outcome completion is adequate if 90% of outcomes are completed
Measured: 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%.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeldysplastic Syndrome (MDS)Studies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled pilot trial
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07528417
- Sponsor's protocol ID
- CHI-002-1
- Acronym
- MYELO-CAN:ABX
- Status last verified
- Jun 2026
- First submitted
- 7 Apr 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Antibiotic Prophylaxis Among Outpatients With Myelodysplastic Syndrome and Acute Myeloid Leukemia: a Multicenter Pilot Trial
- ClinicalTrials.gov ID
- NCT07528417
- Acronym / sponsor ID
- MYELO-CAN:ABX / CHI-002-1
- Conditions
- Myeldysplastic Syndrome (MDS), MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET), Acute Myeloid Leukemia
- Keywords
- Levofloxacin, Randomized Controlled Trial, Myelodysplastic Syndrome, Myeloproliferative Neoplasm, Acute Myeloid Leukemia, Neutropenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled pilot trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Levofloxacin |
| Control group | Active comparator | Other: Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Diagnosis of myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasm, or acute myeloid leukemia
- 1. Initiation of hypomethylating agent-based chemotherapy
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevofloxacinThis group will receive Levofloxacin 500mg orally daily over the 90-day trial period. Patients will take the levofloxacin daily regardless of their neutrophil count. | Drug | Intervention group |
| Usual CareThis group will receive usual care. Routine antibiotic prophylaxis is not permitted. | Other | Control group |
Primary outcome
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).
5 secondary outcomes
Ability to consent 30% of eligible patients
Time frame: 2 years
Protocol adherence
Time frame: 2 years
Off-protocol prophylaxis antibiotic use
Time frame: 2 years
Outcome completion
Time frame: 2 years
Risk of infection
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
Related trials for Myeldysplastic Syndrome (MDS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Levofloxacin in people with Myeldysplastic Syndrome (MDS) and MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET), run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brett Houston, MD, PhD (204-787-8552, bhouston@cancercare.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient enrollment feasibility (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.