NCT01371656 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2020-12-07

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Comparison of the Percentage of Patients Having Bacteremia Incidence Between Levofloxacin vs. No Prophylaxis Arms

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outcome · POSTED

Comparison of the Percentage of Patients Having Antibiotic Exposures Between Arms

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outcome · POSTED

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

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outcome · POSTED

Comparison of the Percentage of Patients Having Severe Infection Between Arms

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

Comparison of the Percentage of Patients Having Incidence of CDAD Between Arms

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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 * 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
healthy Volunteers: false
maximum Age: 21 Years
minimum Age: 6 Months
sex: ALL
std Ages: CHILD
ADULT

Treatment arms and interventions

arm Groups

description
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.
intervention Names
Drug: levofloxacin
label
Arm I (levofloxacin)
type
EXPERIMENTAL
description
Patients receive established standard of care and receive chemotherapy or HSCT as patients in Arm I.
label
Arm II (standard of care)
type
NO_INTERVENTION

interventions

arm Group Labels
Arm I (levofloxacin)
description
Given PO or IV
name
levofloxacin
other Names
Levaquin
Quixin
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: SINGLE

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 624
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Comparison of the Percentage of Patients Having Bacteremia Incidence Between Levofloxacin vs. No Prophylaxis Arms
time Frame
Up to 60 days after enrollment or receiving levofloxacin

secondary Outcomes

description
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
measure
Comparison of the Percentage of Patients Having Antibiotic Exposures Between Arms
time Frame
Up to 60 days after enrollment or receiving levofloxacin
description
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.
measure
Comparison of the Percentage of Patients Having Incidence of Fever and Febrile Neutropenia Between Arms
time Frame
Up to 60 days after enrollment or receiving levofloxacin
description
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
measure
Comparison of the Percentage of Patients Having Severe Infection Between Arms
time Frame
Up to 60 days after enrollment or receiving levofloxacin
measure
Comparison of the Percentage of Patients That Died Due to Bacterial Infection Between Arms
time Frame
Up to 60 days after enrollment or receiving levofloxacin
description
Musculoskeletal conditions included at least one occurrence of arthralgia, arthritis, gait abnormality or tendinopathy.
measure
Comparison of the Percentage of Patients Having Incidence of Musculoskeletal Adverse Events Including Tendinopathy (Tendonitis and Tendon Rupture) Between Arms
time Frame
Enrollment, 2 months and 12 months post infection observation period
description
Clostridium Difficile Associated Disease (CDAD) is defined as a positive C. difficile toxin assay result and diarrhea, CTCAE version 4, grade 2 and higher.
measure
Comparison of the Percentage of Patients Having Incidence of CDAD Between Arms
time Frame
Up to 60 days after enrollment or receiving levofloxacin

Full study description

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.
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.

Source references