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NCT07528417
Evaluation of Antibiotic Prophylaxis in Myelodysplastic Syndromes and Acute Myeloid Leukemia (MYELO-CAN:ABX)
Conditions: Myeldysplastic Syndrome (MDS), MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET), Acute Myeloid Leukemia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 75
Sponsor: University of Manitoba
Location: CancerCare Manitoba Winnipeg Manitoba
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).
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07528417). StuddyBuddy aggregates publicly available trial information.