Diarrhea Clinical Trial
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)
Verified date | June 2018 |
Source | Children's Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 624 |
Est. completion date | June 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 21 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | McMaster Children's Hospital at Hamilton Health Sciences | Hamilton | Ontario |
Canada | Cancer Centre of Southeastern Ontario at Kingston General Hospital | Kingston | Ontario |
Canada | The Montreal Children's Hospital of the MUHC | Montreal | Quebec |
Canada | Janeway Child Health Centre | Saint John's | Newfoundland and Labrador |
Canada | Hospital for Sick Children | Toronto | Ontario |
Canada | CancerCare Manitoba | Winnipeg | Manitoba |
United States | Children's Hospital Medical Center of Akron | Akron | Ohio |
United States | University of New Mexico Cancer Center | Albuquerque | New Mexico |
United States | C S Mott Children's Hospital | Ann Arbor | Michigan |
United States | Mission Hospital-Memorial Campus | Asheville | North Carolina |
United States | Children's Healthcare of Atlanta - Egleston | Atlanta | Georgia |
United States | Georgia Regents University | Augusta | Georgia |
United States | Sinai Hospital of Baltimore | Baltimore | Maryland |
United States | Lehigh Valley Hospital - Muhlenberg | Bethlehem | Pennsylvania |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Floating Hospital for Children at Tufts Medical Center | Boston | Massachusetts |
United States | Montefiore Medical Center | Bronx | New York |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | University of Illinois | Chicago | Illinois |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | Palmetto Health Richland | Columbia | South Carolina |
United States | Nationwide Children's Hospital | Columbus | Ohio |
United States | Driscoll Children's Hospital | Corpus Christi | Texas |
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
United States | Geisinger Medical Center | Danville | Pennsylvania |
United States | The Children's Medical Center of Dayton | Dayton | Ohio |
United States | Blank Children's Hospital | Des Moines | Iowa |
United States | Southern California Permanente Medical Group | Downey | California |
United States | City of Hope Medical Center | Duarte | California |
United States | Golisano Children's Hospital of Southwest Florida | Fort Myers | Florida |
United States | Brooke Army Medical Center | Fort Sam Houston | Texas |
United States | Cook Children's Medical Center | Fort Worth | Texas |
United States | Helen DeVos Children's Hospital at Spectrum Health | Grand Rapids | Michigan |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | Connecticut Children's Medical Center | Hartford | Connecticut |
United States | Baylor College of Medicine | Houston | Texas |
United States | Riley Hospital for Children | Indianapolis | Indiana |
United States | Saint Vincent Hospital and Health Services | Indianapolis | Indiana |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | Nemours Children's Clinic - Jacksonville | Jacksonville | Florida |
United States | Michigan State University - Breslin Cancer Center | Lansing | Michigan |
United States | Nevada Cancer Research Foundation CCOP | Las Vegas | Nevada |
United States | University of Kentucky | Lexington | Kentucky |
United States | Arkansas Children's Hospital | Little Rock | Arkansas |
United States | Loma Linda University Medical Center | Loma Linda | California |
United States | Miller Children's Hospital | Long Beach | California |
United States | Cedars-Sinai Medical Center | Los Angeles | California |
United States | Children's Hospital Los Angeles | Los Angeles | California |
United States | Kosair Children's Hospital | Louisville | Kentucky |
United States | Marshfield Clinic | Marshfield | Wisconsin |
United States | Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota |
United States | Saint Peter's University Hospital | New Brunswick | New Jersey |
United States | UMDNJ - Robert Wood Johnson University Hospital | New Brunswick | New Jersey |
United States | Children's Hospital-Main Campus | New Orleans | Louisiana |
United States | Ochsner Medical Center | New Orleans | Louisiana |
United States | Tulane University Health Sciences Center | New Orleans | Louisiana |
United States | Columbia University Medical Center | New York | New York |
United States | New York University Langone Medical Center | New York | New York |
United States | Childrens Hospital-King's Daughters | Norfolk | Virginia |
United States | Advocate Children's Hospital-Oak Lawn | Oak Lawn | Illinois |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | Children's Hospital and Medical Center of Omaha | Omaha | Nebraska |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | Nemours Children's Hospital | Orlando | Florida |
United States | Nemours Children's Clinic - Pensacola | Pensacola | Florida |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania |
United States | University of Rochester | Rochester | New York |
United States | Saint John's Mercy Medical Center | Saint Louis | Missouri |
United States | All Children's Hospital | Saint Petersburg | Florida |
United States | Methodist Children's Hospital of South Texas | San Antonio | Texas |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
United States | Rady Children's Hospital - San Diego | San Diego | California |
United States | University of California San Francisco Medical Center-Parnassus | San Francisco | California |
United States | Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota |
United States | Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington |
United States | Madigan Army Medical Center | Tacoma | Washington |
United States | The Toledo Hospital/Toledo Children's Hospital | Toledo | Ohio |
United States | Ny Cancer% | Valhalla | New York |
United States | Children's National Medical Center | Washington | District of Columbia |
United States | Lombardi Comprehensive Cancer Center at Georgetown University | Washington | District of Columbia |
United States | Saint Mary's Hospital | West Palm Beach | Florida |
United States | Alfred I duPont Hospital for Children | Wilmington | Delaware |
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Children's Oncology Group | National Cancer Institute (NCI) |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of the Percentage of Patients Having Bacteremia Incidence Between Levofloxacin vs. No Prophylaxis Arms | A bacteremia incidence is defined as an occurrence of at least 1 episode of true (centrally reviewed) bacteremia among Acute Leukemia (AL) and Hematopoietic stem cell transplantation (HSCT) patients. | Up to 60 days after enrollment or receiving levofloxacin | |
Secondary | Comparison of the Percentage of Patients Having Antibiotic Exposures Between Arms | Exposure to antibiotics was considered during the infection observation period(s) was defined a priori as follows: Gram positive agents = vancomycin, linezolid, daptomycin or quinupristin/dalfopristin; Aminoglycosides = amikacin, gentamicin or tobramycin; Third or fourth generation cephalosporins = cefepime, ceftazidime, ceftriaxone or cefotaxime; Empiric antibiotics for fever and neutropenia = imipenem, meropenem, cefepime, ceftazidime or piperacillin/tazobactam | Up to 60 days after enrollment or receiving levofloxacin | |
Secondary | Comparison of the Percentage of Patients Having Incidence of Fever and Febrile Neutropenia Between Arms | Fever and febrile neutropenia defined as Absolute Neutrophil Count (ANC) < 1000/mm3 with a single temperature of >38.3 degrees C (101 degrees F) or a sustained temperature of >= 38 degrees C (100.4 degrees F) for more than one hour. | Up to 60 days after enrollment or receiving levofloxacin | |
Secondary | Comparison of the Percentage of Patients Having Severe Infection Between Arms | Severe infection defined as any grade 4 or 5 CTCAE catheter-related infection, enterocolitis, lung infection, sepsis, small intestine infection and other infections or infestations | Up to 60 days after enrollment or receiving levofloxacin | |
Secondary | Comparison of the Percentage of Patients That Died Due to Bacterial Infection Between Arms | Up to 60 days after enrollment or receiving levofloxacin | ||
Secondary | Comparison of the Percentage of Patients Having Incidence of Musculoskeletal Adverse Events Including Tendinopathy (Tendonitis and Tendon Rupture) Between Arms | Musculoskeletal conditions included at least one occurrence of arthralgia, arthritis, gait abnormality or tendinopathy. | Enrollment, 2 months and 12 months post infection observation period | |
Secondary | Comparison of the Percentage of Patients Having Incidence of CDAD Between Arms | Clostridium Difficile Associated Disease (CDAD) is defined as a positive C. difficile toxin assay result and diarrhea, CTCAE version 4, grade 2 and higher. | Up to 60 days after enrollment or receiving levofloxacin |
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