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

Last updated: November 23, 2020
Sponsor: Children's Oncology Group
Overall Status: Completed

Phase

3

Condition

Bacterial Infections

Leukemia

Sunspot Fungus (Tinea Versicolor)

Treatment

N/A

Clinical Study ID

NCT01371656
ACCL0934
CDR0000695661
U10CA095861
ACCL0934
NCI-2011-02636
COG-ACCL0934
  • Ages 6-21
  • All Genders

Study 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

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 thefirst 2 cycles) of intensive chemotherapy for either:
  • De novo, relapsed or secondary acute myeloid leukemia (AML), or acuteleukemia of ambiguous lineage treated with standard AML therapy
  • Relapsed acute lymphoblastic leukemia (ALL)
  • For the purposes of this study, "intensive chemotherapy" is defined asregimens that are predicted by the local investigator to causeneutropenia 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, andclofarabine-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 HSCTare those in which the conditioning regimen is predicted by the localInvestigator to cause neutropenia for > 7 days
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) > 70 mL/min/1.73m^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 OncologyGroup (ECOG) scores of 0, 1, or 2; use Karnofsky for patients > 16 years of age andLansky for patients =< 16 years of age
  • All patients and/or their parents or legal guardians must sign a written informedconsent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion

Exclusion Criteria:

  • Patients previously enrolled on the trial are not eligible; therefore, patients withAL who were on study during intensive chemotherapy are not eligible to be enrolledduring 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 pentamidineadministered 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 havecompleted the 90 day observation period of that study

Study Design

Total Participants: 624
Study Start date:
September 01, 2011
Estimated Completion Date:
June 30, 2017

Study Description

PRIMARY OBJECTIVES:

I. To determine whether levofloxacin given prophylactically during periods of neutropenia to patients being treated with chemotherapy for acute leukemia (AL) or undergoing hematopoietic stem cell transplantation (HSCT) will decrease the incidence of bacteremia.

SECONDARY OBJECTIVES:

I. To determine the effect of prophylactic levofloxacin on resistance patterns of bacterial isolates from all sterile site cultures, and the evolution of antimicrobial resistance from peri-rectal swab isolates of Enterobacteriaceae, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Streptococcus mitis.

II. To determine the effect of levofloxacin prophylaxis on total number of days of antibiotic administration (prophylactic, empiric, and treatment) in children undergoing therapy for AL or HSCT.

III. To determine whether levofloxacin prophylaxis reduces the incidence of fever with neutropenia, severe infection, and death from bacterial infection.

IV. To assess the safety of levofloxacin prophylaxis, with specific attention to musculoskeletal disorders including tendinopathy and tendon rupture.

V. To assess the impact of prophylactic levofloxacin on the incidence of Clostridium difficile-associated diarrhea (CDAD), and the incidence of microbiologically documented invasive fungal infections (IFI).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive levofloxacin orally (PO) or intravenously (IV) over 60-90 minutes once daily (QD) or twice daily (BID) beginning on day 3 during 2 consecutive courses of chemotherapy or beginning on day -2 during HSCT and continuing until blood counts recover.

ARM II: Patients receive established standard of care and receive chemotherapy or HSCT as patients in Arm I.

After completion of study therapy, patients are followed up for 1 year.

Connect with a study center

  • British Columbia Children's Hospital

    Vancouver, British Columbia V6H 3V4
    Canada

    Site Not Available

  • CancerCare Manitoba

    Winnipeg, Manitoba R3E 0V9
    Canada

    Site Not Available

  • Janeway Child Health Centre

    Saint John's, Newfoundland and Labrador A1B 3V6
    Canada

    Site Not Available

  • McMaster Children's Hospital at Hamilton Health Sciences

    Hamilton, Ontario L8N 3Z5
    Canada

    Site Not Available

  • Cancer Centre of Southeastern Ontario at Kingston General Hospital

    Kingston, Ontario K7L 5P9
    Canada

    Site Not Available

  • Hospital for Sick Children

    Toronto, Ontario M5G 1X8
    Canada

    Site Not Available

  • The Montreal Children's Hospital of the MUHC

    Montreal, Quebec H3H 1P3
    Canada

    Site Not Available

  • Arkansas Children's Hospital

    Little Rock, Arkansas 72202-3591
    United States

    Site Not Available

  • Children's Oncology Group

    Arcadia, California 91006-3776
    United States

    Site Not Available

  • Southern California Permanente Medical Group

    Downey, California 90242
    United States

    Site Not Available

  • City of Hope Medical Center

    Duarte, California 91010
    United States

    Site Not Available

  • Loma Linda University Medical Center

    Loma Linda, California 92354
    United States

    Site Not Available

  • Miller Children's Hospital

    Long Beach, California 90806
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Children's Hospital Los Angeles

    Los Angeles, California 90027
    United States

    Site Not Available

  • Rady Children's Hospital - San Diego

    San Diego, California 92123
    United States

    Site Not Available

  • University of California San Francisco Medical Center-Parnassus

    San Francisco, California 94143
    United States

    Site Not Available

  • Connecticut Children's Medical Center

    Hartford, Connecticut 06106
    United States

    Site Not Available

  • Alfred I duPont Hospital for Children

    Wilmington, Delaware 19803
    United States

    Site Not Available

  • Children's National Medical Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Lombardi Comprehensive Cancer Center at Georgetown University

    Washington, District of Columbia 20057
    United States

    Site Not Available

  • Children's National Medical Center

    Washington, D.C., District of Columbia 20010
    United States

    Site Not Available

  • Golisano Children's Hospital of Southwest Florida

    Fort Myers, Florida 33908
    United States

    Site Not Available

  • Nemours Children's Clinic - Jacksonville

    Jacksonville, Florida 32207-8426
    United States

    Site Not Available

  • Nemours Children's Hospital

    Orlando, Florida 32827
    United States

    Site Not Available

  • Nemours Children's Clinic - Pensacola

    Pensacola, Florida 32504
    United States

    Site Not Available

  • All Children's Hospital

    Saint Petersburg, Florida 33701
    United States

    Site Not Available

  • Saint Mary's Hospital

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Children's Healthcare of Atlanta - Egleston

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Georgia Regents University

    Augusta, Georgia 30912
    United States

    Site Not Available

  • University of Illinois

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Advocate Children's Hospital-Oak Lawn

    Oak Lawn, Illinois 60453
    United States

    Site Not Available

  • Riley Hospital for Children

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Saint Vincent Hospital and Health Services

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • Blank Children's Hospital

    Des Moines, Iowa 50309
    United States

    Site Not Available

  • University of Kentucky

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • Kosair Children's Hospital

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Tulane Cancer Center Office of Clinical Research

    Alexandria, Louisiana 71315-3198
    United States

    Site Not Available

  • Children's Hospital-Main Campus

    New Orleans, Louisiana 70118
    United States

    Site Not Available

  • Ochsner Medical Center

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Tulane University Health Sciences Center

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Sinai Hospital of Baltimore

    Baltimore, Maryland 21215
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Floating Hospital for Children at Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • C S Mott Children's Hospital

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Helen DeVos Children's Hospital at Spectrum Health

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Michigan State University - Breslin Cancer Center

    Lansing, Michigan 48910
    United States

    Site Not Available

  • Children's Hospitals and Clinics of Minnesota - Minneapolis

    Minneapolis, Minnesota 55404
    United States

    Site Not Available

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Saint John's Mercy Medical Center

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Children's Hospital and Medical Center of Omaha

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • Nevada Cancer Research Foundation CCOP

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Saint Peter's University Hospital

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • UMDNJ - Robert Wood Johnson University Hospital

    New Brunswick, New Jersey 08903
    United States

    Site Not Available

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico 87106
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467-2490
    United States

    Site Not Available

  • Roswell Park Cancer Institute

    Buffalo, New York 14263
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • New York University Langone Medical Center

    New York, New York 10016
    United States

    Site Not Available

  • University of Rochester

    Rochester, New York 14642
    United States

    Site Not Available

  • Montefiore Medical Center

    The Bronx, New York 10467-2490
    United States

    Site Not Available

  • Ny Cancer%

    Valhalla, New York 10595
    United States

    Site Not Available

  • Mission Hospital-Memorial Campus

    Asheville, North Carolina 28801
    United States

    Site Not Available

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Children's Hospital Medical Center of Akron

    Akron, Ohio 44308
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Nationwide Children's Hospital

    Columbus, Ohio 43205
    United States

    Site Not Available

  • The Children's Medical Center of Dayton

    Dayton, Ohio 45404
    United States

    Site Not Available

  • The Toledo Hospital/Toledo Children's Hospital

    Toledo, Ohio 43606
    United States

    Site Not Available

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania 18017
    United States

    Site Not Available

  • Geisinger Medical Center

    Danville, Pennsylvania 17822-2001
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • Palmetto Health Richland

    Columbia, South Carolina 29203
    United States

    Site Not Available

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota 57117-5134
    United States

    Site Not Available

  • Driscoll Children's Hospital

    Corpus Christi, Texas 78411
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • Brooke Army Medical Center

    Fort Sam Houston, Texas 78234
    United States

    Site Not Available

  • Cook Children's Medical Center

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • Methodist Children's Hospital of South Texas

    San Antonio, Texas 78229
    United States

    Site Not Available

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas 78229-3900
    United States

    Site Not Available

  • Childrens Hospital-King's Daughters

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Providence Sacred Heart Medical Center and Children's Hospital

    Spokane, Washington 99204
    United States

    Site Not Available

  • Madigan Army Medical Center

    Tacoma, Washington 98431
    United States

    Site Not Available

  • Marshfield Clinic

    Marshfield, Wisconsin 54449
    United States

    Site Not Available

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