Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation

Completed · Phase 3

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT01371656

Run by

Children's Oncology Group

People needed

624

Starts

2011-09-01

Expected to finish

2017-06-01

Last updated by the study team

2020-12-07

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Southern California Permanente Medical Group — Downey, California, United States
• City of Hope Medical Center — Duarte, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Miller Children's Hospital — Long Beach, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Rady Children's Hospital - San Diego — San Diego, California, United States
• University of California San Francisco Medical Center-Parnassus — San Francisco, California, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Alfred I duPont Hospital for Children — Wilmington, Delaware, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Lombardi Comprehensive Cancer Center at Georgetown University — Washington D.C., District of Columbia, United States
• Golisano Children's Hospital of Southwest Florida — Fort Myers, Florida, United States
• Nemours Children's Clinic - Jacksonville — Jacksonville, Florida, United States
• Nemours Children's Hospital — Orlando, Florida, United States
• Nemours Children's Clinic - Pensacola — Pensacola, Florida, United States
• All Children's Hospital — St. Petersburg, Florida, United States
• Saint Mary's Hospital — West Palm Beach, Florida, United States
• Children's Healthcare of Atlanta - Egleston — Atlanta, Georgia, United States
• Georgia Regents University — Augusta, Georgia, United States
• University of Illinois — Chicago, Illinois, United States
• Advocate Children's Hospital-Oak Lawn — Oak Lawn, Illinois, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• Saint Vincent Hospital and Health Services — Indianapolis, Indiana, United States
• Arkansas Children's Hospital — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.