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

NCT01371656 | Completed Phase 3 Results DMC

• 5 other identifiers: ACCL0934NCI-2011-02636CDR0000695661COG-ACCL0934U10CA095861
• Study Type: interventional
• Target: 624
• Locations: 2 countries
• Sites: 84

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Comparison of the Percentage of Patients Having Antibiotic Exposures Between Arms

  Up to 60 days after enrollment or receiving levofloxacin

• Comparison of the Percentage of Patients Having Incidence of Fever and Febrile Neutropenia Between Arms

  Up to 60 days after enrollment or receiving levofloxacin

• Comparison of the Percentage of Patients Having Severe Infection Between Arms

  Up to 60 days after enrollment or receiving levofloxacin

• Comparison of the Percentage of Patients That Died Due to Bacterial Infection Between Arms

  Up to 60 days after enrollment or receiving levofloxacin

• Comparison of the Percentage of Patients Having Incidence of Musculoskeletal Adverse Events Including Tendinopathy (Tendonitis and Tendon Rupture) Between Arms

  Enrollment, 2 months and 12 months post infection observation period

Study Arms (2)

Arm I (levofloxacin)

EXPERIMENTAL

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

Arm II (standard of care)

NO INTERVENTION

Patients receive established standard of care and receive chemotherapy or HSCT as patients in Arm I.

Interventions

levofloxacin DRUG

Given PO or IV

Also known as: Levaquin, Quixin

Arm I (levofloxacin)

Eligibility Criteria

• Age: 6 Months - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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:
• mg/dL (6 months to \< 1 year of age)
• mg/dL (1 to \< 2 years of age)
• mg/dL (2 to \< 6 years of age)
• mg/dL (6 to \< 10 years of age)
• mg/dL (10 to \< 13 years of age)

You may not qualify if:

• 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
• Patients currently enrolled on the ACCL1034 study are not eligible until they have completed the 90 day observation period of that study

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (84)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202-3591, United States

Location

Southern California Permanente Medical Group

Downey, California, 90242, United States

Location

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Miller Children's Hospital

Long Beach, California, 90806, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Rady Children's Hospital - San Diego

San Diego, California, 92123, United States

Location

University of California San Francisco Medical Center-Parnassus

San Francisco, California, 94143, United States

Location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Alfred I duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Lombardi Comprehensive Cancer Center at Georgetown University

Washington D.C., District of Columbia, 20057, United States

Location

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, 33908, United States

Location

Nemours Children's Clinic - Jacksonville

Jacksonville, Florida, 32207-8426, United States

Location

Nemours Children's Hospital

Orlando, Florida, 32827, United States

Location

Nemours Children's Clinic - Pensacola

Pensacola, Florida, 32504, United States

Location

All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

Saint Mary's Hospital

West Palm Beach, Florida, 33407, United States

Location

Children's Healthcare of Atlanta - Egleston

Atlanta, Georgia, 30322, United States

Location

Georgia Regents University

Augusta, Georgia, 30912, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

Advocate Children's Hospital-Oak Lawn

Oak Lawn, Illinois, 60453, United States

Location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Saint Vincent Hospital and Health Services

Indianapolis, Indiana, 46260, United States

Location

Blank Children's Hospital

Des Moines, Iowa, 50309, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Kosair Children's Hospital

Louisville, Kentucky, 40202, United States

Location

Tulane University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Children's Hospital-Main Campus

New Orleans, Louisiana, 70118, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

Floating Hospital for Children at Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

C S Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

Location

Helen DeVos Children's Hospital at Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

Michigan State University - Breslin Cancer Center

Lansing, Michigan, 48910, United States

Location

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, 55404, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Saint John's Mercy Medical Center

St Louis, Missouri, 63141, United States

Location

Children's Hospital and Medical Center of Omaha

Omaha, Nebraska, 68114, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Nevada Cancer Research Foundation CCOP

Las Vegas, Nevada, 89106, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Saint Peter's University Hospital

New Brunswick, New Jersey, 08901, United States

Location

UMDNJ - Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08903, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

New York University Langone Medical Center

New York, New York, 10016, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467-2490, United States

Location

Ny Cancer%

Valhalla, New York, 10595, United States

Location

Mission Hospital-Memorial Campus

Asheville, North Carolina, 28801, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

The Children's Medical Center of Dayton

Dayton, Ohio, 45404, United States

Location

The Toledo Hospital/Toledo Children's Hospital

Toledo, Ohio, 43606, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, 18017, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

Palmetto Health Richland

Columbia, South Carolina, 29203, United States

Location

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134, United States

Location

Driscoll Children's Hospital

Corpus Christi, Texas, 78411, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Cook Children's Medical Center

Fort Worth, Texas, 76104, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States

Location

Methodist Children's Hospital of South Texas

San Antonio, Texas, 78229, United States

Location

Childrens Hospital-King's Daughters

Norfolk, Virginia, 23507, United States

Location

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, 99204, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

Marshfield Clinic

Marshfield, Wisconsin, 54449, United States

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Janeway Child Health Centre

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

McMaster Children's Hospital at Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada

Location

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Kingston, Ontario, K7L 5P9, Canada

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

The Montreal Children's Hospital of the MUHC

Montreal, Quebec, H3H 1P3, Canada

Location

Related Links

• Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive

MeSH Terms

Conditions

Leukemia, Biphenotypic, Acute; Bacterial Infections; Diarrhea; Mycoses; Neutropenia; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Levofloxacin

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Bacterial Infections and Mycoses; Infections; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Agranulocytosis; Leukopenia; Cytopenia; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Results Reporting Coordinator
• Organization: Children's Oncology Group

resultsreportingcoordinator@childrensoncologygroup.org

352-273-0567

Study Officials

• Sarah Alexander, MD

  Children's Oncology Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2011
• First Posted: June 13, 2011
• Study Start: September 1, 2011
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: December 7, 2020
• Results First Posted: June 26, 2018

Record last verified: 2018-06

Locations

US (78); CA (6)