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Trial record 1 of 1 for:    COG ACCL0934
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Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Children's Oncology Group
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group Identifier:
First received: June 4, 2011
Last updated: January 4, 2017
Last verified: January 2017
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.

Condition Intervention Phase
Acute Leukemias of Ambiguous Lineage
Bacterial Infection
Fungal Infection
Musculoskeletal Complications
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood Acute Myeloid Leukemia
Secondary Acute Myeloid Leukemia
Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies
Drug: levofloxacin
Phase 3

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

Resource links provided by NLM:

Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Occurrence of at least 1 episode of true bacteremia among AL and HSCT subjects, respectively [ Time Frame: Up to 60 days ] [ Designated as safety issue: No ]
    Compared between arms using the Chi-square test. Evaluated using logistic regression models.

Secondary Outcome Measures:
  • Susceptibility of E. coli, K. pneumoniae, and P. aeruginosa stool or peri-rectal swab isolates to cefepime, imipenem, and levofloxacin [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Susceptibility of S. mitis peri-rectal swab isolates to cefepime, levofloxacin, and penicillin [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Presence of carbapenem-resistant Enterobacteriaceae [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Resistance patterns for the gastrointestinal isolates colonizing each patient [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Resistance patterns of bacterial isolates from all sterile site cultures [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Duration of parenteral antibiotic administration [ Time Frame: During 2 courses of chemotherapy or 1 transplantation procedure ] [ Designated as safety issue: No ]
    Compared between the 2 arms using 2-sample t-test. Wilcoxon rank sum test will also be considered. Estimated using linear regression models.

  • Incidence of febrile neutropenia [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Compared between arms using the Chi-square test. Evaluated using logistic regression models. Graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0.

  • Incidence of severe infection [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Compared between arms using the Chi-square test. Evaluated using logistic regression models. Graded using the NCI CTCAE v. 4.0.

  • Incidence of death from bacterial infection [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Compared between arms using the Chi-square test. Evaluated using logistic regression models. Graded using the NCI CTCAE v. 4.0.

  • Incidence of musculoskeletal adverse events [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Compared between arms using the Chi-square test. Evaluated using logistic regression models. Graded using the NCI CTCAE v. 4.0.

  • Incidence of tendinopathy (tendonitis and tendon rupture) [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Separate levofloxacin patients into those with/without concurrent steroid use and comparing them separately to control patients, or adjusting for concurrent steroid use as covariate in logistic regression models.

  • Incidence of CDAD, defined as a positive C. difficile toxin assay result and diarrhea, CTCAE version 4, grade 2 and higher [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Compared by separating levofloxacin patients into those with/without concurrent steroid use or adjusting for concurrent steroid use as a covariate in logistic regression models.

Estimated Enrollment: 740
Study Start Date: June 2011
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (levofloxacin)
Patients receive levofloxacin PO or IV over 60-90 minutes once or twice daily beginning on day 3 during 2 consecutive courses of chemotherapy or beginning on day -2 during HSCT and continuing until blood counts recover.
Drug: levofloxacin
Given PO or IV
Other Names:
  • Levaquin
  • Quixin
No Intervention: Arm II (standard of care)
Patients receive established standard of care and receive chemotherapy or HSCT as patients in Arm I.

Detailed Description:


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.


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.


Ages Eligible for Study:   6 Months to 21 Years   (Child, Adult)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01371656

  Hide Study Locations
United States, Arkansas
Arkansas Children's Hospital Recruiting
Little Rock, Arkansas, United States, 72202-3591
Contact: David L. Becton    501-364-7373      
Principal Investigator: David L. Becton         
University of Arkansas for Medical Sciences Withdrawn
Little Rock, Arkansas, United States, 72205
United States, California
Southern California Permanente Medical Group Recruiting
Downey, California, United States, 90242
Contact: Robert M. Cooper    626-564-3455      
Principal Investigator: Robert M. Cooper         
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Theresa M. Harned    323-361-4110      
Principal Investigator: Theresa M. Harned         
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: Antranik A. Bedros    909-558-3375      
Principal Investigator: Antranik A. Bedros         
Miller Children's Hospital Recruiting
Long Beach, California, United States, 90806
Contact: Amanda M. Termuhlen    562-933-5437      
Principal Investigator: Amanda M. Termuhlen         
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Leo Mascarenhas    323-361-4110      
Principal Investigator: Leo Mascarenhas         
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Fataneh (Fae) Majlessipour    310-423-8965      
Principal Investigator: Fataneh (Fae) Majlessipour         
Rady Children's Hospital - San Diego Active, not recruiting
San Diego, California, United States, 92123
University of California San Francisco Medical Center-Parnassus Recruiting
San Francisco, California, United States, 94143
Contact: Christopher C. Dvorak    877-827-3222      
Principal Investigator: Christopher C. Dvorak         
United States, Connecticut
Connecticut Children's Medical Center Active, not recruiting
Hartford, Connecticut, United States, 06106
United States, Delaware
Alfred I duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Christopher N. Frantz    302-651-5755      
Principal Investigator: Christopher N. Frantz         
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Jeffrey S. Dome    202-884-2549      
Principal Investigator: Jeffrey S. Dome         
Lombardi Comprehensive Cancer Center at Georgetown University Recruiting
Washington, District of Columbia, United States, 20057
Contact: Aziza T. Shad    202-444-0381      
Principal Investigator: Aziza T. Shad         
United States, Florida
Lee Memorial Health System Withdrawn
Fort Myers, Florida, United States, 33901
Golisano Children's Hospital of Southwest Florida Recruiting
Fort Myers, Florida, United States, 33908
Contact: Emad K. Salman    239-343-5333      
Principal Investigator: Emad K. Salman         
Nemours Children's Clinic - Jacksonville Recruiting
Jacksonville, Florida, United States, 32207-8426
Contact: Eric S. Sandler    904-697-3529      
Principal Investigator: Eric S. Sandler         
Nemours Childrens Clinic - Orlando Withdrawn
Orlando, Florida, United States, 32806
Nemours Children's Hospital Recruiting
Orlando, Florida, United States, 32827
Contact: Ramamoorthy Nagasubramanian    407-650-7150      
Principal Investigator: Ramamoorthy Nagasubramanian         
Nemours Children's Clinic - Pensacola Recruiting
Pensacola, Florida, United States, 32504
Contact: Jeffrey H. Schwartz    904-697-3529      
Principal Investigator: Jeffrey H. Schwartz         
All Children's Hospital Recruiting
Saint Petersburg, Florida, United States, 33701
Contact: Gregory A. Hale    727-767-2423   
Principal Investigator: Gregory A. Hale         
Saint Mary's Hospital Recruiting
West Palm Beach, Florida, United States, 33407
Contact: Narayana Gowda    888-823-5923   
Principal Investigator: Narayana Gowda         
United States, Georgia
Children's Healthcare of Atlanta - Egleston Recruiting
Atlanta, Georgia, United States, 30322
Contact: Glen Lew    404-785-1112      
Principal Investigator: Glen Lew         
Georgia Regents University Recruiting
Augusta, Georgia, United States, 30912
Contact: Colleen H. McDonough    706-721-1663   
Principal Investigator: Colleen H. McDonough         
United States, Illinois
University of Illinois Active, not recruiting
Chicago, Illinois, United States, 60612
Advocate Children's Hospital-Oak Lawn Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Ammar Hayani    800-323-8622      
Principal Investigator: Ammar Hayani         
United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Robert J. Fallon    317-274-2552      
Principal Investigator: Robert J. Fallon         
Saint Vincent Hospital and Health Services Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Bassem I. Razzouk    317-338-2194      
Principal Investigator: Bassem I. Razzouk         
United States, Iowa
Blank Children's Hospital Recruiting
Des Moines, Iowa, United States, 50309
Contact: Wendy L. Woods-Swafford    515-241-6729      
Principal Investigator: Wendy L. Woods-Swafford         
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Martha F. Greenwood    859-257-3379      
Principal Investigator: Martha F. Greenwood         
Kosair Children's Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Alexandra C. Cheerva    866-530-5516      
Principal Investigator: Alexandra C. Cheerva         
United States, Louisiana
Tulane University Health Sciences Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Tammuella C. Singleton    504-988-6121      
Principal Investigator: Tammuella C. Singleton         
Children's Hospital-Main Campus Active, not recruiting
New Orleans, Louisiana, United States, 70118
Ochsner Medical Center Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Craig Lotterman    888-562-4763      
Principal Investigator: Craig Lotterman         
United States, Maryland
University of Maryland Greenebaum Cancer Center Withdrawn
Baltimore, Maryland, United States, 21201-1595
Sinai Hospital of Baltimore Recruiting
Baltimore, Maryland, United States, 21215
Contact: Joseph M. Wiley    410-601-6120   
Principal Investigator: Joseph M. Wiley         
United States, Massachusetts
Floating Hospital for Children at Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Michael J. Kelly    617-636-5000   
Principal Investigator: Michael J. Kelly         
Dana-Farber Cancer Institute Active, not recruiting
Boston, Massachusetts, United States, 02115
United States, Michigan
C S Mott Children's Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Rama Jasty    419-251-8210      
Principal Investigator: Rama Jasty         
Helen DeVos Children's Hospital at Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: David S. Dickens    616-267-1925      
Principal Investigator: David S. Dickens         
Michigan State University - Breslin Cancer Center Terminated
Lansing, Michigan, United States, 48910
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Bruce C. Bostrom    612-813-5193      
Principal Investigator: Bruce C. Bostrom         
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Gail C. Megason    601-815-6700      
Principal Investigator: Gail C. Megason         
United States, Missouri
Saint John's Mercy Medical Center Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Bethany G. Sleckman    913-948-5588      
Principal Investigator: Bethany G. Sleckman         
United States, Nebraska
Children's Hospital and Medical Center of Omaha Recruiting
Omaha, Nebraska, United States, 68114
Contact: Minnie Abromowitch    402-955-3949      
Principal Investigator: Minnie Abromowitch         
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Minnie Abromowitch    402-955-3949      
Principal Investigator: Minnie Abromowitch         
United States, Nevada
Nevada Cancer Research Foundation CCOP Recruiting
Las Vegas, Nevada, United States, 89106
Contact: Jonathan Bernstein    702-384-0013      
Principal Investigator: Jonathan Bernstein         
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Steven H. Diamond    201-996-2879      
Principal Investigator: Steven H. Diamond         
Saint Peter's University Hospital Active, not recruiting
New Brunswick, New Jersey, United States, 08901
UMDNJ - Robert Wood Johnson University Hospital Active, not recruiting
New Brunswick, New Jersey, United States, 08903
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Koh B. Boayue    505-272-6972      
Principal Investigator: Koh B. Boayue         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467-2490
Contact: Rosanna J. Ricafort    718-904-2730   
Principal Investigator: Rosanna J. Ricafort         
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Martin L. Brecher    877-275-7724      
Principal Investigator: Martin L. Brecher         
New York University Langone Medical Center Active, not recruiting
New York, New York, United States, 10016
Columbia University Medical Center Active, not recruiting
New York, New York, United States, 10032
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Jeffrey R. Andolina    585-275-5830      
Principal Investigator: Jeffrey R. Andolina         
Ny Cancer% Recruiting
Valhalla, New York, United States, 10595
Contact: Mehmet F. Ozkaynak    914-594-3794      
Principal Investigator: Mehmet F. Ozkaynak         
United States, North Carolina
Mission Hospital-Memorial Campus Recruiting
Asheville, North Carolina, United States, 28801
Contact: Krystal S. Bottom    828-213-4150      
Principal Investigator: Krystal S. Bottom         
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Thomas W. McLean    336-713-6771      
Principal Investigator: Thomas W. McLean         
United States, Ohio
Children's Hospital Medical Center of Akron Recruiting
Akron, Ohio, United States, 44308
Contact: Steven J. Kuerbitz    330-543-3193      
Principal Investigator: Steven J. Kuerbitz         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Margaret C. Thompson    866-223-8100      
Principal Investigator: Margaret C. Thompson         
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Mark A. Ranalli    614-722-2708      
Principal Investigator: Mark A. Ranalli         
The Children's Medical Center of Dayton Recruiting
Dayton, Ohio, United States, 45404
Contact: Emmett H. Broxson    800-228-4055      
Principal Investigator: Emmett H. Broxson         
The Toledo Hospital/Toledo Children's Hospital Recruiting
Toledo, Ohio, United States, 43606
Contact: Jamie L. Dargart    419-824-1842      
Principal Investigator: Jamie L. Dargart         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Rene Y. McNall-Knapp    405-271-4272   
Principal Investigator: Rene Y. McNall-Knapp         
United States, Pennsylvania
Lehigh Valley Hospital - Muhlenberg Recruiting
Bethlehem, Pennsylvania, United States, 18017
Contact: Philip M. Monteleone    484-884-2201      
Principal Investigator: Philip M. Monteleone         
Geisinger Medical Center Active, not recruiting
Danville, Pennsylvania, United States, 17822-2001
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: L. C. Bailey    215-590-2810      
Principal Investigator: L. C. Bailey         
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Arthur K. Ritchey    412-692-5573      
Principal Investigator: Arthur K. Ritchey         
United States, South Carolina
Palmetto Health Richland Recruiting
Columbia, South Carolina, United States, 29203
Contact: Ronnie W. Neuberg    803-434-3680      
Principal Investigator: Ronnie W. Neuberg         
United States, South Dakota
Sanford USD Medical Center - Sioux Falls Recruiting
Sioux Falls, South Dakota, United States, 57117-5134
Contact: Kayelyn J. Wagner    605-328-1367      
Principal Investigator: Kayelyn J. Wagner         
United States, Texas
Driscoll Children's Hospital Recruiting
Corpus Christi, Texas, United States, 78411
Contact: M. C. Johnson    361-694-5311      
Principal Investigator: M. C. Johnson         
University of Texas Southwestern Medical Center Active, not recruiting
Dallas, Texas, United States, 75390
Brooke Army Medical Center Active, not recruiting
Fort Sam Houston, Texas, United States, 78234
Cook Children's Medical Center Active, not recruiting
Fort Worth, Texas, United States, 76104
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Julienne Brackett    713-798-1354   
Principal Investigator: Julienne Brackett         
University of Texas Health Science Center at San Antonio Terminated
San Antonio, Texas, United States, 78229-3900
Methodist Children's Hospital of South Texas Active, not recruiting
San Antonio, Texas, United States, 78229
United States, Virginia
Childrens Hospital-King's Daughters Recruiting
Norfolk, Virginia, United States, 23507
Contact: Eric J. Lowe    757-668-7243      
Principal Investigator: Eric J. Lowe         
United States, Washington
Providence Sacred Heart Medical Center and Children's Hospital Active, not recruiting
Spokane, Washington, United States, 99204
Madigan Army Medical Center Recruiting
Tacoma, Washington, United States, 98431
Contact: Melissa A. Forouhar    253-968-0129   
Principal Investigator: Melissa A. Forouhar         
United States, Wisconsin
Marshfield Clinic Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Michael J. McManus    715-389-4457      
Principal Investigator: Michael J. McManus         
Canada, British Columbia
British Columbia Children's Hospital Withdrawn
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Rochelle A. Yanofsky    866-561-1026   
Principal Investigator: Rochelle A. Yanofsky         
Canada, Newfoundland and Labrador
Janeway Child Health Centre Recruiting
Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
Contact: Lisa Anne B. Goodyear    866-722-1126      
Principal Investigator: Lisa Anne B. Goodyear         
Canada, Ontario
McMaster Children's Hospital at Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Carol Portwine    905-521-2100ext74595      
Principal Investigator: Carol Portwine         
Cancer Centre of Southeastern Ontario at Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L 5P9
Contact: Mariana P. Silva    613-544-2630      
Principal Investigator: Mariana P. Silva         
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Ronald M. Grant    416-813-7654ext2027   
Principal Investigator: Ronald M. Grant         
Canada, Quebec
The Montreal Children's Hospital of the MUHC Recruiting
Montreal, Quebec, Canada, H3H 1P3
Contact: Sharon B. Abish    514-412-4445   
Principal Investigator: Sharon B. Abish         
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Sarah Alexander, MD Children's Oncology Group
  More Information

Responsible Party: Children's Oncology Group Identifier: NCT01371656     History of Changes
Other Study ID Numbers: ACCL0934  NCI-2011-02636  CDR0000695661  ACCL0934  COG-ACCL0934  ACCL0934  U10CA095861 
Study First Received: June 4, 2011
Last Updated: January 4, 2017
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Communicable Diseases
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Acute Disease
Bacterial Infections
Neoplasms by Histologic Type
Signs and Symptoms, Digestive
Signs and Symptoms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease Attributes
Pathologic Processes
Leukocyte Disorders
Hematologic Diseases
Anti-Infective Agents, Urinary
Anti-Infective Agents processed this record on January 14, 2017