View Clinical Trial (Medical Research Study)
A Randomized Trial of Levofloxacin to Prevent Bacteremia in Children Being Treated for Acute Leukemia (AL) or Undergoing Hematopoietic Stem Cell Transplantation (HSCT)
| City: |
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Sioux Falls |
| State: |
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South Dakota |
| Zip Code: |
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57117 |
| Conditions: |
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Bacterial Infection - Leukemia - Musculoskeletal Complications - Neutropenia |
| Purpose: |
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RATIONALE: 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.
PURPOSE: This randomized phase III trial studies how well levofloxacin works in preventing
infection in young patients receiving chemotherapy for acute leukemia or undergoing stem
cell transplant.
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| Study Summary: |
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OBJECTIVES:
Primary
- 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
- 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.
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| Criteria: |
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DISEASE CHARACTERISTICS:
- 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
ifosfamide/etoposide
- 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.
PATIENT CHARACTERISTICS:
- 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
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No patients scheduled to receive non-intensive or palliative chemotherapy
- No patients undergoing non-myeloablative hematopoietic stem cell transplantation
(HSCT)
- No patients being treated with antibacterial agents, other than cotrimoxazole for
Pneumocystitis jiroveci (PCP) prophylaxis
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| NCT ID: |
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NCT01371656 |
| Primary Contact: |
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Study Chair
Sarah Alexander, MD
The Hospital for Sick Children
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| Backup Contact: |
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N/A |
| Location Contact: |
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Sioux Falls, South Dakota 57117
United States
Clinical Trials Office - Sanford Cancer Center
Phone: 605-328-1367
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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