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A Randomized Trial of Levofloxacin to Prevent Bacteremia in Children Being Treated for Acute Leukemia (AL) or Undergoing Hematopoietic Stem Cell Transplantation (HSCT)

Phase 3
21 Years
Open (Enrolling)
Bacterial Infection, Leukemia, Musculoskeletal Complications, Neutropenia

Thank you

Trial Information

A Randomized Trial of Levofloxacin to Prevent Bacteremia in Children Being Treated for Acute Leukemia (AL) or Undergoing Hematopoietic Stem Cell Transplantation (HSCT)



- 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


- 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 Escherichia coli, Klebsiella pneumoniae,
Pseudomonas aeruginosa, and Streptococcus mitis.

- 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.

- To determine whether levofloxacin prophylaxis reduces the incidence of fever with
neutropenia, severe infection, and death from bacterial infection.

- To assess the safety of levofloxacin prophylaxis, with specific attention to
musculoskeletal disorders including tendinopathy and tendon rupture.

- 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: This is a multicenter study. Patients are stratified according to diagnosis (de
novo acute myeloid leukemia [AML] vs secondary AML vs relapsed AML vs relapsed acute
lymphoblastic leukemia [ALL]), and therapy (undergoing autologous HSCT vs undergoing
allogeneic HSCT). Patients are randomized to 1 of 2 treatment groups.

- Arm I: Patients receive levofloxacin orally (PO) or IV over 60-90 minutes once or twice
daily beginning on day 1 during 2 consecutive courses of chemotherapy or beginning on
day -2 during hematopoietic stem cell transplantation (HSCT) and continuing until blood
counts recover.

- Arm II: Patients receive established standard of care and receive chemotherapy or HSCT
as patients in arm 1.

Musculoskeletal assessment is conducted at baseline and at 2 and 12 months.

Patients may undergo perirectal or stool swab collection for ancillary studies.

After completion of study therapy, patients are followed up for 1 year.

Inclusion Criteria


- Patients must fit 1 of the following categories:

- Chemotherapy patients

- Scheduled to receive at least 2 consecutive courses (not required to be the
first 2 courses) of intensive chemotherapy for de novo, relapsed, or
secondary acute myeloid leukemia (AML), or 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 including, but not limited to:

- Treatment with "4-drug induction" (anthracycline, vincristine,
asparaginase, and steroid)

- High-dose cytarabine, anthracycline/cytarabine, or

- Clofarabine-containing regimens

- Stem cell transplantation patients*

- Scheduled to receive at least 1 myeloablative autologous or allogeneic
hematopoietic stem cell transplantation (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 NOTE: *Patients with AML or
ALL who were enrolled on this study during intensive chemotherapy are not
eligible to be enrolled during HSCT.


- ECOG performance status 0-2

- Creatinine clearance or radioisotope GFR > 70 mL/min OR serum creatinine based on age
and/or 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) or 1.4 mg/dL (female) (13 to < 16 years of age)

- 1.7 mg/dL (male) or 1.4 mg/dL (female) (≥ 16 years of age)

- No patients with an allergy to quinolones

- No patients with chronic active arthritis

- No patients with a known pathologic prolongation of the QTc

- No females who are pregnant or breast feeding


- See Disease Characteristics

- No patients scheduled to receive non-intensive or palliative chemotherapy

- No patients undergoing non-myeloablative hematopoietic stem cell transplantation

- No patients being treated with antibacterial agents, other than cotrimoxazole for
Pneumocystitis jiroveci (PCP) prophylaxis

Type of Study:


Study Design:

Allocation: Randomized, Masking: Single Blind, Primary Purpose: Supportive Care

Outcome Measure:

Occurrence of at least 1 episode of true bacteremia during the study timeframe of 2 courses of chemotherapy or 1 transplant procedure among AL and HSCT subjects, respectively

Safety Issue:


Principal Investigator

Sarah Alexander, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Hospital for Sick Children



Study ID:




Start Date:

June 2011

Completion Date:

Related Keywords:

  • Bacterial Infection
  • Leukemia
  • Musculoskeletal Complications
  • Neutropenia
  • bacterial infection
  • musculoskeletal complications
  • neutropenia
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with del(5q)
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • secondary acute myeloid leukemia
  • recurrent adult acute myeloid leukemia
  • untreated adult acute myeloid leukemia
  • untreated childhood acute myeloid leukemia and other myeloid malignancies
  • recurrent childhood acute myeloid leukemia
  • recurrent adult acute lymphoblastic leukemia
  • recurrent childhood acute lymphoblastic leukemia
  • Bacterial Infections
  • Leukemia
  • Neutropenia



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