Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation
Condition: Acute Leukemias of Ambiguous Lineage; Bacterial Infection; Diarrhea; Fungal Infection; Musculoskeletal Complications; Neutropenia; Recurrent Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia; Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Mycoses; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Neutropenia; Recurrence; Diarrhea; Acute Disease
Intervention: levofloxacin
Intervention description: Given PO or IV
Intervention MeSH terms: Levofloxacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Enrollment: 624.0
Sex: All
Minimum age: 6 Months
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      This randomized phase III trial studies how well levofloxacin works in preventing infection
      in young patients with acute leukemia receiving chemotherapy or undergoing stem cell
      transplant. Giving antibiotics may be effective in preventing or controlling early infection
      in patients receiving chemotherapy or undergoing stem cell transplant for acute leukemia. It
      is not yet known whether levofloxacin is effective in preventing infection.
    

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