Clinical trial · Interventional
Evaluation of Antibiotic Prophylaxis in Myelodysplastic Syndromes and Acute Myeloid Leukemia (MYELO-CAN:ABX)
Evaluation of Antibiotic Prophylaxis Among Outpatients With Myelodysplastic Syndrome and Acute Myeloid Leukemia: a Multicenter Pilot Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myeldysplastic Syndrome (MDS) | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
| MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET) | Myeloproliferative Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Levofloxacin | Drug | — | UNRESOLVED |
| Usual Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group
- interventionNames
- Drug: Levofloxacin
- type
- ACTIVE_COMPARATOR
- label
- Control group
- interventionNames
- Other: Usual Care
Primary outcomes (1)
- measure
- Patient enrollment feasibility
- timeFrame
- 2 years
- description
- 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 (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available