Intervention: Ofloxacin
Trial phase: Phase 3
ATC code: A02BD10 | J01MA01 | J01MA12 | J01RA05 | J01RA09 | S01AE01 | S01AE05 | S02AA16
SMILES: CC1COc2c(N3CCN(C)CC3)c(F)cc3c(=O)c(C(=O)O)cn1c23
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 306
Group description: Patients receive levofloxacin PO or IV over 60-90 minutes once or twice daily beginning on day 3 during 2 consecutive courses of chemotherapy or beginning on day -2 during HSCT and continuing until blood counts recover.

levofloxacin: Given PO or IV
Eligibility criteria:
Inclusion Criteria:

Patient must fit 1 of the following 2 categories:

Chemotherapy patients

Planned to receive at least 2 consecutive cycles (not required to be the first 2 cycles) of intensive chemotherapy for either:

De novo, relapsed or secondary acute myeloid leukemia (AML), or acute leukemia of ambiguous lineage treated with standard AML therapy
Relapsed acute lymphoblastic leukemia (ALL)
For the purposes of this study, "intensive chemotherapy" is defined as regimens that are predicted by the local investigator to cause neutropenia for > 7 days; examples include, but are not limited to, treatment with "4-drug induction" (anthracycline, vincristine, asparaginase, and steroid), high dose cytarabine, anthracycline/cytarabine, ifosfamide/etoposide, and clofarabine-containing regimens

Stem cell transplantation patients

Planned to receive at least 1 myeloablative autologous or allogeneic HSCT
For the purposes of this study, myeloablative autologous and allogeneic HSCT are those in which the conditioning regimen is predicted by the local Investigator to cause neutropenia for > 7 days

Creatinine clearance or radioisotope glomerular filtration rate (GFR) > 70 mL/min/1.73 m^2 OR serum creatinine based on age/gender as follows:

0.5 mg/dL (6 months to < 1 year of age)
0.6 mg/dL (1 to < 2 years of age)
0.8 mg/dL (2 to < 6 years of age)
1.0 mg/dL (6 to < 10 years of age)
1.2 mg/dL (10 to < 13 years of age)
1.5 mg/dL (male)/1.4 mg/dL (female) (13 to < 16 years of age)
1.7 mg/dL (male)/1.4 mg/dL (female) (>= 16 years of age)
Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
All patients and/or their parents or legal guardians must sign a written informed consent
All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria:

Patients previously enrolled on the trial are not eligible; therefore, patients with AL who were on study during intensive chemotherapy are not eligible to be enrolled during the HSCT
Patients with an allergy to quinolones
Patients with chronic active arthritis
Patients with a known pathologic prolongation of the corrected QT (QTc)
Females who are pregnant or breast feeding

Patients being treated with antibacterial agents, other than any of the following:

Cotrimoxazole or other agents including dapsone, atovaquone, and pentamidine administered for Pneumocystitis jiroveci (PCP) prophylaxis
Topical antibiotics
Central venous catheter antibiotic lock therapy
Note: prophylactic antifungal therapy is NOT an exclusion criterion
Patients currently enrolled on the ACCL1034 study are not eligible until they have completed the 90 day observation period of that study