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

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Basic Trial Information

PhaseTypeAgeTrial IDs
Phase IIISupportive care6 months to 21 yearsACCL0934
NCI-2011-02636, CDR0000695661, COG-ACCL0934, NCT01371656

Trial Description

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.

Further Study Information

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.

Eligibility Criteria

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

All patients and/or their parents or legal guardians must sign a written informed consent

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 institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

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)

Exclusion Criteria:

Patients with an allergy to quinolones

Patients with chronic active arthritis

Females who are pregnant or breast feeding

Patients with a known pathologic prolongation of the corrected QT (QTc)

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

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

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Children's Oncology Group

  • National Cancer Institute
Sarah Weeks Alexander, Principal Investigator

Trial Sites

U.S.A.

Arkansas
Little Rock

Arkansas Children's Hospital

David L. Becton
Ph: 501-364-7373

David L. Becton
Principal Investigator

California
Downey

Southern California Permanente Medical Group

Robert Michael Cooper
Ph: 626-564-3455

Robert Michael Cooper
Principal Investigator

Duarte

City of Hope Comprehensive Cancer Center

Sarah Weeks Alexander

Sarah Weeks Alexander
Principal Investigator

Loma Linda

Loma Linda University Medical Center

Albert Kheradpour
Ph: 909-558-3375

Albert Kheradpour
Principal Investigator

Long Beach

Miller Children's and Women's Hospital Long Beach

Cecilia Hsing-I Fu
Ph: 323-361-4110

Cecilia Hsing-I Fu
Principal Investigator

Los Angeles

Cedars-Sinai Medical Center

Fataneh (Fae) Majlessipour
Ph: 310-423-8965

Fataneh (Fae) Majlessipour
Principal Investigator

Children's Hospital Los Angeles

Leo Mascarenhas
Ph: 323-361-4110

Leo Mascarenhas
Principal Investigator

Oakland

Children's Hospital and Research Center at Oakland

Mark C. Walters
Ph: 510-450-7600

Mark C. Walters
Principal Investigator

San Diego

Rady Children's Hospital - San Diego

William D. Roberts
Ph: 858-966-5934

William D. Roberts
Principal Investigator

San Francisco

UCSF Medical Center-Mission Bay

Christopher C. Dvorak
Ph: 877-827-3222

Christopher C. Dvorak
Principal Investigator

Colorado
Aurora

Children's Hospital Colorado

Kristen Michelle Eisenman
Ph: 720-777-6672

Kristen Michelle Eisenman
Principal Investigator

Connecticut
Hartford

Connecticut Children's Medical Center

Michael Scott Isakoff
Ph: 860-545-9981

Michael Scott Isakoff
Principal Investigator

New Haven

Yale University

Nina Singh Kadan-Lottick
Ph: 203-785-5702

Nina Singh Kadan-Lottick
Principal Investigator

Delaware
Wilmington

Alfred I duPont Hospital for Children

Scott M. Bradfield
Ph: 904-697-3529

Scott M. Bradfield
Principal Investigator

District of Columbia
Washington

Children's National Medical Center

Jeffrey Stuart Dome
Ph: 202-884-2549

Jeffrey Stuart Dome
Principal Investigator

Florida
Fort Myers

Golisano Children's Hospital of Southwest Florida

Emad K. Salman
Ph: 239-343-5333

Emad K. Salman
Principal Investigator

Jacksonville

Nemours Children's Clinic-Jacksonville

Scott M. Bradfield
Ph: 904-697-3529

Scott M. Bradfield
Principal Investigator

Orlando

Nemours Children's Hospital

Scott M. Bradfield
Ph: 904-697-3529

Scott M. Bradfield
Principal Investigator

Pensacola

Nemours Children's Clinic - Pensacola

Scott M. Bradfield
Ph: 904-697-3529

Scott M. Bradfield
Principal Investigator

Saint Petersburg

All Children's Hospital

Gregory Alan Hale
Ph: 727-767-2423
Email: HamblinF@allkids.org

Gregory Alan Hale
Principal Investigator

Tampa

Tampa General Hospital

Cameron K. Tebbi
Ph: 800-882-4123
Email: hkourtellis@tgh.org

Cameron K. Tebbi
Principal Investigator

West Palm Beach

Saint Mary's Hospital

Narayana Gowda
Ph: 888-823-5923
Email: ctsucontact@westat.com

Narayana Gowda
Principal Investigator

Georgia
Atlanta

Children's Healthcare of Atlanta - Egleston

Glen Lew
Ph: 404-785-1112

Glen Lew
Principal Investigator

Augusta

Georgia Regents University Medical Center

Colleen H. McDonough
Ph: 706-721-1663
Email: cancer@georgiahealth.edu

Colleen H. McDonough
Principal Investigator

Illinois
Chicago

University of Illinois

Mary Lou Schmidt
Ph: 312-355-3046

Mary Lou Schmidt
Principal Investigator

Oak Lawn

Advocate Children's Hospital-Oak Lawn

Rebecca Erin McFall
Ph: 847-723-7570

Rebecca Erin McFall
Principal Investigator

Springfield

Southern Illinois University School of Medicine

Gregory P. Brandt
Ph: 217-545-7929

Gregory P. Brandt
Principal Investigator

Indiana
Indianapolis

Riley Hospital for Children

Robert J. Fallon
Ph: 888-823-5923
Email: ctsucontact@westat.com

Robert J. Fallon
Principal Investigator

Iowa
Des Moines

Blank Children's Hospital

Wendy Leigh Woods-Swafford
Ph: 515-241-6729

Wendy Leigh Woods-Swafford
Principal Investigator

Kentucky
Lexington

University of Kentucky/Markey Cancer Center

Lars Martin Wagner
Ph: 859-257-3379

Lars Martin Wagner
Principal Investigator

Louisville

Kosair Children's Hospital

Alexandra C. Cheerva
Ph: 866-530-5516

Alexandra C. Cheerva
Principal Investigator

Louisiana
New Orleans

Children's Hospital New Orleans

Lolie C. Yu
Ph: 504-894-5377

Lolie C. Yu
Principal Investigator

Ochsner Medical Center Jefferson

Craig Lotterman
Ph: 888-562-4763

Craig Lotterman
Principal Investigator

Maryland
Baltimore

Sinai Hospital of Baltimore

Joseph M. Wiley
Ph: 410-601-6120
Email: pridgely@lifebridgehealth.org

Joseph M. Wiley
Principal Investigator

Massachusetts
Boston

Dana-Farber Cancer Institute

Carlos Rodriguez-Galindo
Ph: 877-442-3324

Carlos Rodriguez-Galindo
Principal Investigator

Floating Hospital for Children at Tufts Medical Center

Michael J. Kelly
Ph: 617-636-5000
Email: ContactUsCancerCenter@TuftsMedicalCenter.org

Michael J. Kelly
Principal Investigator

Michigan
Ann Arbor

C S Mott Children's Hospital

Rama Jasty
Ph: 419-251-8210

Rama Jasty
Principal Investigator

East Lansing

Michigan State University Clinical Center

Renuka Gera
Ph: 517-975-9547

Renuka Gera
Principal Investigator

Grand Rapids

Helen DeVos Children's Hospital at Spectrum Health

David Scott Dickens
Ph: 616-267-1925

David Scott Dickens
Principal Investigator

Minnesota
Minneapolis

Children's Hospitals and Clinics of Minnesota - Minneapolis

Michael Kerr Richards
Ph: 612-813-5193

Michael Kerr Richards
Principal Investigator

Mississippi
Jackson

University of Mississippi Medical Center

Gail Cranshaw Megason
Ph: 601-815-6700

Gail Cranshaw Megason
Principal Investigator

Missouri
Saint Louis

Mercy Hospital Saint Louis

Bethany Graham Sleckman
Ph: 913-948-5588

Bethany Graham Sleckman
Principal Investigator

Nebraska
Omaha

Children's Hospital and Medical Center of Omaha

Minnie Abromowitch
Ph: 402-955-3949

Minnie Abromowitch
Principal Investigator

University of Nebraska Medical Center

Minnie Abromowitch
Ph: 402-955-3949

Minnie Abromowitch
Principal Investigator

Nevada
Las Vegas

Children's Specialty Center of Nevada II

Jonathan Bernstein
Ph: 702-384-0013

Jonathan Bernstein
Principal Investigator

Nevada Cancer Research Foundation CCOP

Jonathan Bernstein
Ph: 702-384-0013

Jonathan Bernstein
Principal Investigator

Summerlin Hospital Medical Center

Jonathan Bernstein
Ph: 702-384-0013

Jonathan Bernstein
Principal Investigator

Sunrise Hospital and Medical Center

Nik Farahana Nik Abdul Rashid
Ph: 702-384-0013

Nik Farahana Nik Abdul Rashid
Principal Investigator

University Medical Center of Southern Nevada

Jonathan Bernstein
Ph: 702-384-0013

Jonathan Bernstein
Principal Investigator

New Jersey
Hackensack

Hackensack University Medical Center

Steven H. Diamond
Ph: 201-996-2879

Steven H. Diamond
Principal Investigator

New Brunswick

Saint Peter's University Hospital

Stanley Calderwood
Ph: 732-745-8600ext6163
Email: kcovert@saintpetersuh.com

Stanley Calderwood
Principal Investigator

UMDNJ - Robert Wood Johnson University Hospital

Richard A. Drachtman
Ph: 732-235-8675

Richard A. Drachtman
Principal Investigator

New Mexico
Albuquerque

University of New Mexico

Sarah Weeks Alexander

Sarah Weeks Alexander
Principal Investigator

University of New Mexico Cancer Center

Koh B. Boayue
Ph: 505-272-6972

Koh B. Boayue
Principal Investigator

New York
Albany

Albany Medical Center

Vikramjit Singh Kanwar
Ph: 518-262-3368

Vikramjit Singh Kanwar
Principal Investigator

Bronx

Montefiore Medical Center - Moses Campus

Peter David Cole
Ph: 718-904-2730
Email: aecc@aecom.yu.edu

Peter David Cole
Principal Investigator

Buffalo

Roswell Park Cancer Institute

Martin Louis Brecher
Ph: 877-275-7724

Martin Louis Brecher
Principal Investigator

New York

Columbia University Medical Center

Alice Lee
Ph: 212-305-8615

Alice Lee
Principal Investigator

Laura and Issac Perlmutter Cancer Center at NYU Langone

Linda Granowetter
Ph: 212-263-4434
Email: prmc.coordinator@nyumc.org

Linda Granowetter
Principal Investigator

Rochester

University of Rochester

Jeffrey Robert Andolina
Ph: 585-275-5830

Jeffrey Robert Andolina
Principal Investigator

Valhalla

New York Medical College

Jessica Cassara Hochberg
Ph: 914-594-3794

Jessica Cassara Hochberg
Principal Investigator

North Carolina
Asheville

Mission Hospital-Memorial Campus

Douglas James Scothorn
Ph: 828-213-4150

Douglas James Scothorn
Principal Investigator

Durham

Duke University Medical Center

Susan G. Kreissman
Ph: 888-275-3853

Susan G. Kreissman
Principal Investigator

Winston-Salem

Wake Forest University Health Sciences

Thomas Williams McLean
Ph: 336-713-6771

Thomas Williams McLean
Principal Investigator

Ohio
Akron

Children's Hospital Medical Center of Akron

Steven J. Kuerbitz
Ph: 330-543-3193

Steven J. Kuerbitz
Principal Investigator

Cleveland

Cleveland Clinic Foundation

Margaret C. Thompson
Ph: 866-223-8100

Margaret C. Thompson
Principal Investigator

Rainbow Babies and Childrens Hospital

Yousif (Joe) H. Matloub
Ph: 216-844-5437

Yousif (Joe) H. Matloub
Principal Investigator

Columbus

Nationwide Children's Hospital

Mark Anthony Ranalli
Ph: 614-722-2708

Mark Anthony Ranalli
Principal Investigator

Dayton

Dayton Children's Hospital

Ayman Ali El-Sheikh
Ph: 800-237-1225

Ayman Ali El-Sheikh
Principal Investigator

Toledo

The Toledo Hospital/Toledo Children's Hospital

Jamie L. Dargart
Ph: 419-824-1842

Jamie L. Dargart
Principal Investigator

Oklahoma
Oklahoma City

University of Oklahoma Health Sciences Center

Rene Yvonne McNall-Knapp
Ph: 405-271-4272
Email: julie-traylor@ouhsc.edu

Rene Yvonne McNall-Knapp
Principal Investigator

Pennsylvania
Bethlehem

Lehigh Valley Hospital - Muhlenberg

Philip M. Monteleone
Ph: 484-884-2201

Philip M. Monteleone
Principal Investigator

Danville

Geisinger Medical Center

Jagadeesh Ramdas
Ph: 570-271-5251

Jagadeesh Ramdas
Principal Investigator

Philadelphia

Children's Hospital of Philadelphia

L. Charles Bailey
Ph: 215-590-2810

L. Charles Bailey
Principal Investigator

Pittsburgh

Children's Hospital of Pittsburgh of UPMC

Arthur Kim Ritchey
Ph: 412-692-5573

Arthur Kim Ritchey
Principal Investigator

South Carolina
Columbia

Palmetto Health Richland

Ronnie W. Neuberg
Ph: 803-434-3680

Ronnie W. Neuberg
Principal Investigator

South Dakota
Sioux Falls

Sanford USD Medical Center - Sioux Falls

Kayelyn Jean Wagner
Ph: 605-328-1367

Kayelyn Jean Wagner
Principal Investigator

Texas
Corpus Christi

Driscoll Children's Hospital

M. Cris Johnson
Ph: 361-694-5311

M. Cris Johnson
Principal Investigator

Dallas

UT Southwestern/Simmons Cancer Center-Dallas

Naomi Joan Winick
Ph: 214-648-7097

Naomi Joan Winick
Principal Investigator

Fort Worth

Cook Children's Medical Center

Gretchen Marie Eames
Ph: 682-885-2103

Gretchen Marie Eames
Principal Investigator

Houston

Baylor College of Medicine

Julienne Brackett
Ph: 713-798-1354
Email: burton@bcm.edu

Julienne Brackett
Principal Investigator

San Antonio

Methodist Children's Hospital of South Texas

Jaime Estrada
Ph: 210-575-7000

Jaime Estrada
Principal Investigator

University of Texas Health Science Center at San Antonio

Anne-Marie R. Langevin
Ph: 210-450-3800
Email: CTO@uthscsa.edu

Anne-Marie R. Langevin
Principal Investigator

Virginia
Norfolk

Childrens Hospital-King's Daughters

Eric Jeffrey Lowe
Ph: 757-668-7243

Eric Jeffrey Lowe
Principal Investigator

Washington
Spokane

Providence Sacred Heart Medical Center and Children's Hospital

Judy L. Felgenhauer
Ph: 800-228-6618
Email: HopeBeginsHere@providence.org

Judy L. Felgenhauer
Principal Investigator

Tacoma

Madigan Army Medical Center

Melissa Anne Forouhar
Ph: 253-968-0129
Email: mamcdci@amedd.army.mil

Melissa Anne Forouhar
Principal Investigator

Wisconsin
Marshfield

Marshfield Clinic

Michael John McManus
Ph: 715-389-4457

Michael John McManus
Principal Investigator

Milwaukee

Midwest Children's Cancer Center

Paul David Harker-Murray
Ph: 414-805-4380

Paul David Harker-Murray
Principal Investigator

Canada

Manitoba
Winnipeg

CancerCare Manitoba

Rochelle Avis Yanofsky
Ph: 866-561-1026
Email: CIO_Web@cancercare.mb.ca

Rochelle Avis Yanofsky
Principal Investigator

Newfoundland and Labrador
Saint John's

Janeway Child Health Centre

Lisa Anne Beresford Goodyear
Ph: 866-722-1126

Lisa Anne Beresford Goodyear
Principal Investigator

Ontario
Hamilton

McMaster Children's Hospital at Hamilton Health Sciences

Carol Portwine
Ph: 905-521-2100ext74595

Carol Portwine
Principal Investigator

Kingston

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Mariana Pradier Silva
Ph: 613-544-2630

Mariana Pradier Silva
Principal Investigator

London

Children's Hospital

Shayna M. Zelcer
Ph: 519-685-8306

Shayna M. Zelcer
Principal Investigator

Ottawa

Children's Hospital of Eastern Ontario

Jacqueline Mary Lewis Halton
Ph: 613-738-3931

Jacqueline Mary Lewis Halton
Principal Investigator

Toronto

Hospital for Sick Children

Sarah Weeks Alexander
Ph: 416-813-7654ext2027
Email: jason.mcguire@sickkids.ca

Sarah Weeks Alexander
Principal Investigator

Quebec
Montreal

The Montreal Children's Hospital of the MUHC

Sharon Barbara Abish
Ph: 514-412-4445
Email: info@thechildren.com

Sharon Barbara Abish
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01371656

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.