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

Trial Status: Complete

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.

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

Arkansas

Little Rock
Arkansas Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: David L. Becton
Phone: 501-364-7373
University of Arkansas for Medical Sciences
Status: CLOSED_TO_ACCRUAL
Contact: David L. Becton
Phone: 501-364-7373

California

Downey
Kaiser Permanente Downey Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Robert Michael Cooper
Phone: 626-564-3455
Duarte
City of Hope Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Anna Beata Pawlowska
Phone: 800-826-4673
Loma Linda
Loma Linda University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Albert Kheradpour
Phone: 909-558-3375
Long Beach
Miller Children's and Women's Hospital Long Beach
Status: CLOSED_TO_ACCRUAL
Contact: Pamela Helen-heilge Kempert
Phone: 562-933-5600
Los Angeles
Cedars Sinai Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Fataneh (Fae) Majlessipour
Phone: 310-423-8965
Children's Hospital Los Angeles
Status: CLOSED_TO_ACCRUAL
Contact: Leo Mascarenhas
Phone: 323-361-4110
Oakland
UCSF Benioff Children's Hospital Oakland
Status: CLOSED_TO_ACCRUAL
Contact: Mark C. Walters
Phone: 510-450-7600
San Diego
Rady Children's Hospital - San Diego
Status: CLOSED_TO_ACCRUAL
Contact: William D. Roberts
Phone: 858-966-5934
San Francisco
UCSF Medical Center-Mission Bay
Status: CLOSED_TO_ACCRUAL
Contact: Christopher C. Dvorak
Phone: 877-827-3222
UCSF Medical Center-Parnassus
Status: CLOSED_TO_ACCRUAL
Contact: Christopher C. Dvorak
Phone: 877-827-3222
Torrance
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Joseph L. Lasky
Phone: 888-662-8252

Colorado

Aurora
Children's Hospital Colorado
Status: CLOSED_TO_ACCRUAL
Contact: Kristen Michelle Eisenman
Phone: 720-777-6672

Connecticut

Hartford
Connecticut Children's Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Michael Scott Isakoff
Phone: 860-545-9981
New Haven
Yale University
Status: CLOSED_TO_ACCRUAL
Contact: Nina Singh Kadan-Lottick
Phone: 203-785-5702

Delaware

Wilmington
Alfred I duPont Hospital for Children
Status: CLOSED_TO_ACCRUAL
Contact: Scott M. Bradfield
Phone: 904-697-3529

District of Columbia

Washington
Children's National Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Jeffrey Stuart Dome
Phone: 202-884-2549
MedStar Georgetown University Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Amal Mousa Abu-Ghosh
Phone: 202-444-0381

Florida

Fort Myers
Golisano Children's Hospital of Southwest Florida
Status: CLOSED_TO_ACCRUAL
Contact: Emad K. Salman
Phone: 239-343-5333
Lee Memorial Health System
Status: CLOSED_TO_ACCRUAL
Contact: Emad K. Salman
Phone: 239-343-5333
Jacksonville
Nemours Children's Clinic-Jacksonville
Status: CLOSED_TO_ACCRUAL
Contact: Scott M. Bradfield
Phone: 904-697-3529
Orlando
Nemours Children's Clinic - Orlando
Status: CLOSED_TO_ACCRUAL
Contact: Ramamoorthy Nagasubramanian
Phone: 407-650-7150
Nemours Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Scott M. Bradfield
Phone: 904-697-3529
Pensacola
Nemours Children's Clinic - Pensacola
Status: CLOSED_TO_ACCRUAL
Contact: Scott M. Bradfield
Phone: 904-697-3529
Saint Petersburg
Johns Hopkins All Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Gregory Alan Hale
Phone: 727-767-2423
Tampa
Tampa General Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Cameron K. Tebbi
Phone: 800-882-4123
West Palm Beach
Saint Mary's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Narayana Gowda

Georgia

Atlanta
Children's Healthcare of Atlanta - Egleston
Status: CLOSED_TO_ACCRUAL
Contact: Joanna G. Newton
Phone: 888-785-1112
Augusta
Augusta University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Colleen H. McDonough
Phone: 706-721-1663

Idaho

Boise
Saint Luke's Cancer Institute - Boise
Status: CLOSED_TO_ACCRUAL
Contact: Eugenia Chang
Phone: 208-381-3376

Illinois

Chicago
University of Illinois
Status: CLOSED_TO_ACCRUAL
Contact: Mary Lou Schmidt
Phone: 312-355-3046
Oak Lawn
Advocate Children's Hospital-Oak Lawn
Status: CLOSED_TO_ACCRUAL
Contact: Rebecca Erin McFall
Phone: 847-723-7570
Springfield
Southern Illinois University School of Medicine
Status: CLOSED_TO_ACCRUAL
Contact: Gregory P. Brandt
Phone: 217-545-7929

Indiana

Indianapolis
Riley Hospital for Children
Status: CLOSED_TO_ACCRUAL
Contact: Robert J. Fallon
Phone: 800-248-1199
Saint Vincent Hospital and Health Care Center
Status: CLOSED_TO_ACCRUAL
Contact: Bassem I. Razzouk
Phone: 317-338-2194

Iowa

Des Moines
Blank Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Wendy Leigh Woods-Swafford
Phone: 515-241-6729

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Lars Martin Wagner
Phone: 859-257-3379
Louisville
Norton Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Kenneth G. Lucas
Phone: 866-530-5516

Louisiana

New Orleans
Children's Hospital New Orleans
Status: CLOSED_TO_ACCRUAL
Contact: Lolie C. Yu
Phone: 504-894-5377
Ochsner Medical Center Jefferson
Status: CLOSED_TO_ACCRUAL
Contact: Craig Lotterman
Phone: 888-562-4763
Tulane University Health Sciences Center
Status: CLOSED_TO_ACCRUAL
Contact: Tammuella Chrisentery Singleton
Phone: 504-988-6121

Maryland

Baltimore
Sinai Hospital of Baltimore
Status: CLOSED_TO_ACCRUAL
Contact: Jason M. Fixler
Phone: 410-601-6120
University of Maryland / Greenebaum Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Teresa Anne York
Phone: 800-888-8823

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Suzanne Shusterman
Phone: 877-442-3324
Tufts Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Michael J. Kelly
Phone: 617-636-5000

Michigan

Ann Arbor
C S Mott Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Rama Jasty
Phone: 800-865-1125
East Lansing
Michigan State University Clinical Center
Status: CLOSED_TO_ACCRUAL
Contact: Renuka Gera
Phone: 517-975-9547
Grand Rapids
Helen DeVos Children's Hospital at Spectrum Health
Status: CLOSED_TO_ACCRUAL
Contact: David Scott Dickens
Phone: 616-391-1230

Minnesota

Minneapolis
Children's Hospitals and Clinics of Minnesota - Minneapolis
Status: CLOSED_TO_ACCRUAL
Contact: Michael Kerr Richards
Phone: 612-813-5193

Mississippi

Jackson
University of Mississippi Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Gail Cranshaw Megason
Phone: 601-815-6700

Missouri

Saint Louis
Mercy Hospital Saint Louis
Status: CLOSED_TO_ACCRUAL
Contact: Bethany Graham Sleckman
Phone: 913-948-5588

Nebraska

Omaha
Children's Hospital and Medical Center of Omaha
Status: CLOSED_TO_ACCRUAL
Contact: Minnie Abromowitch
Phone: 402-955-3949
University of Nebraska Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Minnie Abromowitch
Phone: 402-955-3949

Nevada

Las Vegas
Alliance for Childhood Diseases / Cure 4 the Kids Foundation
Status: CLOSED_TO_ACCRUAL
Contact: Alan K. Ikeda
Phone: 702-384-0013
Nevada Cancer Research Foundation NCORP
Status: CLOSED_TO_ACCRUAL
Contact: Jonathan Bernstein
Phone: 702-384-0013
Summerlin Hospital Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Alan K. Ikeda
Phone: 702-384-0013
Sunrise Hospital and Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Alan K. Ikeda
Phone: 702-384-0013
University Medical Center of Southern Nevada
Status: CLOSED_TO_ACCRUAL
Contact: Jonathan Bernstein
Phone: 702-384-0013

New Jersey

Hackensack
Hackensack University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Steven H. Diamond
Phone: 201-996-2879
New Brunswick
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Richard A. Drachtman
Phone: 732-235-8675
Saint Peter's University Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Stanley Calderwood
Phone: 732-745-8600ext6163

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Koh B. Boayue
Phone: 505-925-0366

New York

Albany
Albany Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Vikramjit Singh Kanwar
Phone: 518-262-3368
Bronx
Montefiore Medical Center - Moses Campus
Status: CLOSED_TO_ACCRUAL
Contact: Jonathan Benjamin Gill
Phone: 718-904-2730
Buffalo
Roswell Park Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Barbara J. Bambach
Phone: 877-275-7724
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: CLOSED_TO_ACCRUAL
Contact: Linda Granowetter
Phone: 212-263-4434
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Alice Lee
Phone: 212-305-8615
Rochester
University of Rochester
Status: CLOSED_TO_ACCRUAL
Contact: Jeffrey Robert Andolina
Phone: 585-275-5830
Valhalla
New York Medical College
Status: CLOSED_TO_ACCRUAL
Contact: Jessica Cassara Hochberg
Phone: 914-594-3794

North Carolina

Asheville
Mission Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Douglas James Scothorn
Phone: 828-213-4150
Durham
Duke University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Susan G. Kreissman
Phone: 888-275-3853
Winston-Salem
Wake Forest University Health Sciences
Status: CLOSED_TO_ACCRUAL
Contact: Thomas Bennett Russell
Phone: 336-713-6771

Ohio

Akron
Children's Hospital Medical Center of Akron
Status: CLOSED_TO_ACCRUAL
Contact: Steven J. Kuerbitz
Phone: 330-543-3193
Cleveland
Cleveland Clinic Foundation
Status: CLOSED_TO_ACCRUAL
Contact: Aron Flagg
Phone: 866-223-8100
Rainbow Babies and Childrens Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Yousif (Joe) H. Matloub
Phone: 216-844-5437
Columbus
Nationwide Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Mark Anthony Ranalli
Phone: 614-722-2708
Dayton
Dayton Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Ayman Aly El-Sheikh
Phone: 800-228-4055
Toledo
ProMedica Toledo Hospital / Russell J Ebeid Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Jamie L. Dargart
Phone: 419-824-1842

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: CLOSED_TO_ACCRUAL
Contact: Rene Y McNall-Knapp
Phone: 405-271-8777

Pennsylvania

Bethlehem
Lehigh Valley Hospital - Muhlenberg
Status: CLOSED_TO_ACCRUAL
Contact: Philip M. Monteleone
Phone: 484-884-2201
Danville
Geisinger Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Jagadeesh Ramdas
Phone: 570-271-5251
Philadelphia
Children's Hospital of Philadelphia
Status: CLOSED_TO_ACCRUAL
Contact: L. Charles Bailey
Phone: 215-590-2810
Pittsburgh
Children's Hospital of Pittsburgh of UPMC
Status: CLOSED_TO_ACCRUAL
Contact: Arthur Kim Ritchey
Phone: 412-692-5573

South Carolina

Columbia
Prisma Health Richland Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Ronnie W. Neuberg
Phone: 803-434-3680

South Dakota

Sioux Falls
Sanford USD Medical Center - Sioux Falls
Status: CLOSED_TO_ACCRUAL
Contact: Kayelyn Jean Wagner
Phone: 605-328-1367

Tennessee

Chattanooga
T C Thompson Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Manoo G. Bhakta
Phone: 423-778-7289

Texas

Corpus Christi
Driscoll Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Nkechi Ifeoma Mba
Phone: 361-694-5311
Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: CLOSED_TO_ACCRUAL
Contact: Naomi Joan Winick
Phone: 214-648-7097
Fort Sam Houston
Brooke Army Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Della Livesay Howell
Phone: 210-292-7311
Fort Worth
Cook Children's Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Gretchen Marie Eames
Phone: 682-885-2103
Houston
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Julienne Brackett
Phone: 713-798-1354
San Antonio
Methodist Children's Hospital of South Texas
Status: CLOSED_TO_ACCRUAL
Contact: Gerardo Quezada
Phone: 210-575-7000
University of Texas Health Science Center at San Antonio
Status: CLOSED_TO_ACCRUAL
Contact: Anne-Marie R. Langevin
Phone: 210-450-3800

Virginia

Norfolk
Children's Hospital of The King's Daughters
Status: CLOSED_TO_ACCRUAL
Contact: Eric Jeffrey Lowe
Phone: 757-668-7243

Washington

Spokane
Providence Sacred Heart Medical Center and Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Judy L. Felgenhauer
Phone: 800-228-6618
Tacoma
Madigan Army Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Melissa Anne Forouhar
Phone: 253-968-0129

Wisconsin

Marshfield
Marshfield Medical Center-Marshfield
Status: CLOSED_TO_ACCRUAL
Contact: Michael John McManus
Phone: 715-389-4457
Milwaukee
Children's Hospital of Wisconsin
Status: CLOSED_TO_ACCRUAL
Contact: Paul David Harker-Murray
Phone: 414-805-4380

Alberta

Calgary
Alberta Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Douglas R. Strother
Phone: 403-220-6898

British Columbia

Vancouver
British Columbia Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Caron Strahlendorf
Phone: 604-875-2345ext6477

Manitoba

Winnipeg
CancerCare Manitoba
Status: CLOSED_TO_ACCRUAL
Contact: John Joseph Doyle
Phone: 866-561-1026

Newfoundland and Labrador

Saint John's
Janeway Child Health Centre
Status: CLOSED_TO_ACCRUAL
Contact: Lisa Anne Goodyear
Phone: 866-722-1126

Ontario

Hamilton
McMaster Children's Hospital at Hamilton Health Sciences
Status: CLOSED_TO_ACCRUAL
Contact: Carol A. Portwine
Phone: 905-521-2100ext74595
Kingston
Kingston Health Sciences Centre
Status: CLOSED_TO_ACCRUAL
Contact: Mariana Pradier Silva
Phone: 613-544-2630
London
Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Shayna M. Zelcer
Phone: 519-685-8306
Ottawa
Children's Hospital of Eastern Ontario
Status: CLOSED_TO_ACCRUAL
Contact: Jacqueline Mary Lewis Halton
Phone: 613-738-3931
Toronto
Hospital for Sick Children
Status: CLOSED_TO_ACCRUAL
Contact: Sarah Weeks Alexander
Phone: 416-813-7654ext2027

Quebec

Montreal
The Montreal Children's Hospital of the MUHC
Status: CLOSED_TO_ACCRUAL
Contact: Sharon Barbara Abish
Phone: 514-412-4445

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.

Trial Phase Phase III

Trial Type Supportive care

Lead Organization
Children's Oncology Group

Principal Investigator
Sarah Weeks Alexander

  • Primary ID ACCL0934
  • Secondary IDs NCI-2011-02636, COG-ACCL0934, CDR0000695661, S13-00512
  • Clinicaltrials.gov ID NCT01371656