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

Information source: Children's Oncology Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: 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

Intervention: levofloxacin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Children's Oncology Group

Official(s) and/or principal investigator(s):
Sarah Alexander, MD, Principal Investigator, Affiliation: Children's Oncology Group


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.

Clinical Details

Official title: A Randomized Trial of Levofloxacin to Prevent Bacteremia in Children Being Treated for Acute Leukemia (AL) or Undergoing Hematopoietic Stem Cell Transplantation (HSCT)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Primary outcome: Occurrence of at least 1 episode of true bacteremia among AL and HSCT subjects, respectively

Secondary outcome:

Susceptibility of E. coli, K. pneumoniae, and P. aeruginosa stool or peri-rectal swab isolates to cefepime, imipenem, and levofloxacin

Susceptibility of S. mitis peri-rectal swab isolates to cefepime, levofloxacin, and penicillin

Presence of carbapenem-resistant Enterobacteriaceae

Resistance patterns for the gastrointestinal isolates colonizing each patient

Resistance patterns of bacterial isolates from all sterile site cultures

Duration of parenteral antibiotic administration

Incidence of febrile neutropenia

Incidence of severe infection

Incidence of death from bacterial infection

Incidence of musculoskeletal adverse events

Incidence of tendinopathy (tendonitis and tendon rupture)

Incidence of CDAD, defined as a positive C. difficile toxin assay result and diarrhea, CTCAE version 4, grade 2 and higher

Detailed 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.


Minimum age: 6 Months. Maximum age: 21 Years. Gender(s): Both.


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


- 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

Locations and Contacts

Arkansas Children's Hospital, Little Rock, Arkansas 72202-3591, United States; Recruiting
David L. Becton, Phone: 501-364-7373
David L. Becton, Principal Investigator

University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States; Withdrawn

British Columbia Children's Hospital, Vancouver, British Columbia V6H 3V4, Canada; Withdrawn

Southern California Permanente Medical Group, Downey, California 90242, United States; Recruiting
Robert M. Cooper, Phone: 626-564-3455
Robert M. Cooper, Principal Investigator

City of Hope Medical Center, Duarte, California 91010, United States; Recruiting
Theresa M. Harned, Phone: 323-361-4110
Theresa M. Harned, Principal Investigator

Loma Linda University Medical Center, Loma Linda, California 92354, United States; Recruiting
Antranik A. Bedros, Phone: 909-558-3375
Antranik A. Bedros, Principal Investigator

Miller Children's Hospital, Long Beach, California 90806, United States; Recruiting
Amanda M. Termuhlen, Phone: 562-933-5437
Amanda M. Termuhlen, Principal Investigator

Cedars-Sinai Medical Center, Los Angeles, California 90048, United States; Recruiting
Fataneh (Fae) Majlessipour, Phone: 310-423-8965
Fataneh (Fae) Majlessipour, Principal Investigator

Children's Hospital Los Angeles, Los Angeles, California 90027, United States; Recruiting
Leo Mascarenhas, Phone: 323-361-4110
Leo Mascarenhas, Principal Investigator

Rady Children's Hospital - San Diego, San Diego, California 92123, United States; Active, not recruiting

University of California San Francisco Medical Center-Parnassus, San Francisco, California 94143, United States; Recruiting
Christopher C. Dvorak, Phone: 877-827-3222
Christopher C. Dvorak, Principal Investigator

Connecticut Children's Medical Center, Hartford, Connecticut 06106, United States; Active, not recruiting

Alfred I duPont Hospital for Children, Wilmington, Delaware 19803, United States; Recruiting
Christopher N. Frantz, Phone: 302-651-5755
Christopher N. Frantz, Principal Investigator

Children's National Medical Center, Washington, District of Columbia 20010, United States; Recruiting
Jeffrey S. Dome, Phone: 202-884-2549
Jeffrey S. Dome, Principal Investigator

Lombardi Comprehensive Cancer Center at Georgetown University, Washington, District of Columbia 20057, United States; Recruiting
Aziza T. Shad, Phone: 202-444-0381
Aziza T. Shad, Principal Investigator

Golisano Children's Hospital of Southwest Florida, Fort Myers, Florida 33908, United States; Recruiting
Emad K. Salman, Phone: 239-343-5333
Emad K. Salman, Principal Investigator

Lee Memorial Health System, Fort Myers, Florida 33901, United States; Withdrawn

Nemours Children's Clinic - Jacksonville, Jacksonville, Florida 32207-8426, United States; Recruiting
Eric S. Sandler, Phone: 904-697-3529
Eric S. Sandler, Principal Investigator

Nemours Children's Hospital, Orlando, Florida 32827, United States; Recruiting
Ramamoorthy Nagasubramanian, Phone: 407-650-7150
Ramamoorthy Nagasubramanian, Principal Investigator

Nemours Childrens Clinic - Orlando, Orlando, Florida 32806, United States; Withdrawn

Nemours Children's Clinic - Pensacola, Pensacola, Florida 32504, United States; Recruiting
Jeffrey H. Schwartz, Phone: 904-697-3529
Jeffrey H. Schwartz, Principal Investigator

All Children's Hospital, Saint Petersburg, Florida 33701, United States; Recruiting
Gregory A. Hale, Phone: 727-767-2423, Email: HamblinF@allkids.org
Gregory A. Hale, Principal Investigator

Saint Mary's Hospital, West Palm Beach, Florida 33407, United States; Recruiting
Narayana Gowda, Phone: 888-823-5923, Email: ctsucontact@westat.com
Narayana Gowda, Principal Investigator

Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia 30322, United States; Recruiting
Glen Lew, Phone: 404-785-1112
Glen Lew, Principal Investigator

Georgia Regents University, Augusta, Georgia 30912, United States; Recruiting
Colleen H. McDonough, Phone: 706-721-1663, Email: cancer@georgiahealth.edu
Colleen H. McDonough, Principal Investigator

University of Illinois, Chicago, Illinois 60612, United States; Active, not recruiting

Advocate Children's Hospital-Oak Lawn, Oak Lawn, Illinois 60453, United States; Recruiting
Ammar Hayani, Phone: 800-323-8622
Ammar Hayani, Principal Investigator

Riley Hospital for Children, Indianapolis, Indiana 46202, United States; Recruiting
Robert J. Fallon, Phone: 317-274-2552
Robert J. Fallon, Principal Investigator

Saint Vincent Hospital and Health Services, Indianapolis, Indiana 46260, United States; Recruiting
Bassem I. Razzouk, Phone: 317-338-2194
Bassem I. Razzouk, Principal Investigator

Blank Children's Hospital, Des Moines, Iowa 50309, United States; Recruiting
Wendy L. Woods-Swafford, Phone: 515-241-6729
Wendy L. Woods-Swafford, Principal Investigator

University of Kentucky, Lexington, Kentucky 40536, United States; Recruiting
Martha F. Greenwood, Phone: 859-257-3379
Martha F. Greenwood, Principal Investigator

Kosair Children's Hospital, Louisville, Kentucky 40202, United States; Recruiting
Alexandra C. Cheerva, Phone: 866-530-5516
Alexandra C. Cheerva, Principal Investigator

Children's Hospital-Main Campus, New Orleans, Louisiana 70118, United States; Active, not recruiting

Ochsner Medical Center, New Orleans, Louisiana 70121, United States; Recruiting
Craig Lotterman, Phone: 888-562-4763
Craig Lotterman, Principal Investigator

Tulane University Health Sciences Center, New Orleans, Louisiana 70112, United States; Recruiting
Tammuella C. Singleton, Phone: 504-988-6121
Tammuella C. Singleton, Principal Investigator

CancerCare Manitoba, Winnipeg, Manitoba R3E 0V9, Canada; Recruiting
Rochelle A. Yanofsky, Phone: 866-561-1026, Email: CIO_Web@cancercare.mb.ca
Rochelle A. Yanofsky, Principal Investigator

Sinai Hospital of Baltimore, Baltimore, Maryland 21215, United States; Recruiting
Joseph M. Wiley, Phone: 410-601-6120, Email: pridgely@lifebridgehealth.org
Joseph M. Wiley, Principal Investigator

University of Maryland Greenebaum Cancer Center, Baltimore, Maryland 21201-1595, United States; Withdrawn

Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States; Active, not recruiting

Floating Hospital for Children at Tufts Medical Center, Boston, Massachusetts 02111, United States; Recruiting
Michael J. Kelly, Phone: 617-636-5000, Email: ContactUsCancerCenter@TuftsMedicalCenter.org
Michael J. Kelly, Principal Investigator

C S Mott Children's Hospital, Ann Arbor, Michigan 48109, United States; Recruiting
Rama Jasty, Phone: 419-251-8210
Rama Jasty, Principal Investigator

Helen DeVos Children's Hospital at Spectrum Health, Grand Rapids, Michigan 49503, United States; Recruiting
David S. Dickens, Phone: 616-267-1925
David S. Dickens, Principal Investigator

Michigan State University - Breslin Cancer Center, Lansing, Michigan 48910, United States; Terminated

Children's Hospitals and Clinics of Minnesota - Minneapolis, Minneapolis, Minnesota 55404, United States; Recruiting
Bruce C. Bostrom, Phone: 612-813-5193
Bruce C. Bostrom, Principal Investigator

University of Mississippi Medical Center, Jackson, Mississippi 39216, United States; Recruiting
Gail C. Megason, Phone: 601-815-6700
Gail C. Megason, Principal Investigator

Saint John's Mercy Medical Center, Saint Louis, Missouri 63141, United States; Recruiting
Bethany G. Sleckman, Phone: 913-948-5588
Bethany G. Sleckman, Principal Investigator

Children's Hospital and Medical Center of Omaha, Omaha, Nebraska 68114, United States; Recruiting
Minnie Abromowitch, Phone: 402-955-3949
Minnie Abromowitch, Principal Investigator

University of Nebraska Medical Center, Omaha, Nebraska 68198, United States; Recruiting
Minnie Abromowitch, Phone: 402-955-3949
Minnie Abromowitch, Principal Investigator

Nevada Cancer Research Foundation CCOP, Las Vegas, Nevada 89106, United States; Recruiting
Jonathan Bernstein, Phone: 702-384-0013
Jonathan Bernstein, Principal Investigator

Hackensack University Medical Center, Hackensack, New Jersey 07601, United States; Recruiting
Steven H. Diamond, Phone: 201-996-2879
Steven H. Diamond, Principal Investigator

Saint Peter's University Hospital, New Brunswick, New Jersey 08901, United States; Active, not recruiting

UMDNJ - Robert Wood Johnson University Hospital, New Brunswick, New Jersey 08903, United States; Active, not recruiting

University of New Mexico Cancer Center, Albuquerque, New Mexico 87106, United States; Recruiting
Koh B. Boayue, Phone: 505-272-6972
Koh B. Boayue, Principal Investigator

Montefiore Medical Center, Bronx, New York 10467-2490, United States; Recruiting
Rosanna J. Ricafort, Phone: 718-904-2730, Email: aecc@aecom.yu.edu
Rosanna J. Ricafort, Principal Investigator

Roswell Park Cancer Institute, Buffalo, New York 14263, United States; Recruiting
Martin L. Brecher, Phone: 877-275-7724
Martin L. Brecher, Principal Investigator

Columbia University Medical Center, New York, New York 10032, United States; Active, not recruiting

New York University Langone Medical Center, New York, New York 10016, United States; Active, not recruiting

University of Rochester, Rochester, New York 14642, United States; Recruiting
Jeffrey R. Andolina, Phone: 585-275-5830
Jeffrey R. Andolina, Principal Investigator

Ny Cancer%, Valhalla, New York 10595, United States; Recruiting
Mehmet F. Ozkaynak, Phone: 914-594-3794
Mehmet F. Ozkaynak, Principal Investigator

Janeway Child Health Centre, Saint John's, Newfoundland and Labrador A1B 3V6, Canada; Recruiting
Lisa Anne B. Goodyear, Phone: 866-722-1126
Lisa Anne B. Goodyear, Principal Investigator

Mission Hospital-Memorial Campus, Asheville, North Carolina 28801, United States; Recruiting
Krystal S. Bottom, Phone: 828-213-4150
Krystal S. Bottom, Principal Investigator

Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157, United States; Recruiting
Thomas W. McLean, Phone: 336-713-6771
Thomas W. McLean, Principal Investigator

Children's Hospital Medical Center of Akron, Akron, Ohio 44308, United States; Recruiting
Steven J. Kuerbitz, Phone: 330-543-3193
Steven J. Kuerbitz, Principal Investigator

Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States; Recruiting
Margaret C. Thompson, Phone: 866-223-8100
Margaret C. Thompson, Principal Investigator

Nationwide Children's Hospital, Columbus, Ohio 43205, United States; Recruiting
Mark A. Ranalli, Phone: 614-722-2708
Mark A. Ranalli, Principal Investigator

The Children's Medical Center of Dayton, Dayton, Ohio 45404, United States; Recruiting
Emmett H. Broxson, Phone: 800-228-4055
Emmett H. Broxson, Principal Investigator

The Toledo Hospital/Toledo Children's Hospital, Toledo, Ohio 43606, United States; Recruiting
Jamie L. Dargart, Phone: 419-824-1842
Jamie L. Dargart, Principal Investigator

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma 73104, United States; Recruiting
Rene Y. McNall-Knapp, Phone: 405-271-4272, Email: julie-traylor@ouhsc.edu
Rene Y. McNall-Knapp, Principal Investigator

McMaster Children's Hospital at Hamilton Health Sciences, Hamilton, Ontario L8N 3Z5, Canada; Recruiting
Carol Portwine, Phone: 905-521-2100ext74595
Carol Portwine, Principal Investigator

Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston, Ontario K7L 5P9, Canada; Recruiting
Mariana P. Silva, Phone: 613-544-2630
Mariana P. Silva, Principal Investigator

Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada; Recruiting
Ronald M. Grant, Phone: 416-813-7654ext2027, Email: jason.mcguire@sickkids.ca
Ronald M. Grant, Principal Investigator

Lehigh Valley Hospital - Muhlenberg, Bethlehem, Pennsylvania 18017, United States; Recruiting
Philip M. Monteleone, Phone: 484-884-2201
Philip M. Monteleone, Principal Investigator

Geisinger Medical Center, Danville, Pennsylvania 17822-2001, United States; Active, not recruiting

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States; Recruiting
L. C. Bailey, Phone: 215-590-2810
L. C. Bailey, Principal Investigator

Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania 15224, United States; Recruiting
Arthur K. Ritchey, Phone: 412-692-5573
Arthur K. Ritchey, Principal Investigator

The Montreal Children's Hospital of the MUHC, Montreal, Quebec H3H 1P3, Canada; Recruiting
Sharon B. Abish, Phone: 514-412-4445, Email: info@thechildren.com
Sharon B. Abish, Principal Investigator

Palmetto Health Richland, Columbia, South Carolina 29203, United States; Recruiting
Ronnie W. Neuberg, Phone: 803-434-3680
Ronnie W. Neuberg, Principal Investigator

Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota 57117-5134, United States; Recruiting
Kayelyn J. Wagner, Phone: 605-328-1367
Kayelyn J. Wagner, Principal Investigator

Driscoll Children's Hospital, Corpus Christi, Texas 78411, United States; Recruiting
M. C. Johnson, Phone: 361-694-5311
M. C. Johnson, Principal Investigator

University of Texas Southwestern Medical Center, Dallas, Texas 75390, United States; Active, not recruiting

Brooke Army Medical Center, Fort Sam Houston, Texas 78234, United States; Active, not recruiting

Cook Children's Medical Center, Fort Worth, Texas 76104, United States; Active, not recruiting

Baylor College of Medicine, Houston, Texas 77030, United States; Recruiting
Julienne Brackett, Phone: 713-798-1354, Email: burton@bcm.edu
Julienne Brackett, Principal Investigator

Methodist Children's Hospital of South Texas, San Antonio, Texas 78229, United States; Active, not recruiting

University of Texas Health Science Center at San Antonio, San Antonio, Texas 78229-3900, United States; Terminated

Childrens Hospital-King's Daughters, Norfolk, Virginia 23507, United States; Recruiting
Eric J. Lowe, Phone: 757-668-7243
Eric J. Lowe, Principal Investigator

Providence Sacred Heart Medical Center and Children's Hospital, Spokane, Washington 99204, United States; Active, not recruiting

Madigan Army Medical Center, Tacoma, Washington 98431, United States; Recruiting
Melissa A. Forouhar, Phone: 253-968-0129, Email: mamcdci@amedd.army.mil
Melissa A. Forouhar, Principal Investigator

Marshfield Clinic, Marshfield, Wisconsin 54449, United States; Recruiting
Michael J. McManus, Phone: 715-389-4457
Michael J. McManus, Principal Investigator

Additional Information

Starting date: June 2011
Last updated: February 23, 2015

Page last updated: August 23, 2015

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