Title (COG ACCL0934) A Randomized Trial of Levofloxacin to Prevent Bacteremia in Children Being Treated for Acute Leukemia (AL) or Undergoing Hematopoietic Stem Cell Transplantation (HSCT)
Principal Investigator Barbara Bambach, MD
Study Number 205811
The open-label, randomized, controlled trial will evaluate whether prophylactic therapy with levofloxacin will decrease the incidence of bacteremia in pediatric patients being treated with intensive chemotherapy for acute leukemia or for those undergoing HSCT. In addition, the study design will allow assessment of the potential risks of prophylactic therapy such as impact on host flora and quinolone-related musculoskeletal side effects.
- Greater than or equal to 6 months and less than or equal to 21 years of age at enrollment
- Patients must fit one of the following 2 categories: (a) chemotherapy patients-planned to receive at least 2 consecutive cycles of intensive chemotherapy for either 1) de novo, relapsed or secondary AML or 2) relapsed ALL. OR (b) Stem Cell Transplantation Patients planned to receive at least 1 myeloablative autologous or allogeneic HSCT.
- Adequate renal function as defined in section 3.2.3
- Patients must have a performance status corresponding to ECOG scores of 0, 1, or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients < or equal to 16 years of age.
- Patients previously enrolled on the trial are not eligible
- Patients with an allergy to quinolones, with chronic active arthritis or with a known pathologic prolongation of the QTc are not eligible
- Females who are pregnant or breast feeding are not eligible
- Patients being treated with antibacterial agents, other than cotrimoxazole for pneumocytitis jiroveci (PCP) prophylaxis are not eligible