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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
N/A
21 Years
Open (Enrolling)
Both
Bacterial Infection, Leukemia, Musculoskeletal Complications, Neutropenia

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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)


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.

Inclusion Criteria


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

Type of Study:

Interventional

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:

No

Principal Investigator

Sarah Alexander, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Hospital for Sick Children

Authority:

Unspecified

Study ID:

CDR0000695661

NCT ID:

NCT01371656

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

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Children's National Medical CenterWashington, District of Columbia  20010-2970
Nemours Children's ClinicJacksonville, Florida  32207
All Children's HospitalSt. Petersburg, Florida  33701
Children's Hospital of New OrleansNew Orleans, Louisiana  70118
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Southern California Permanente Medical GroupDowney, California  90242
Kosair Children's HospitalLouisville, Kentucky  40202-3830
Children's Hospital of the King's DaughtersNorfolk, Virginia  23507
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Loma Linda University Cancer Institute at Loma Linda University Medical CenterLoma Linda, California  92354
Lee Cancer Care of Lee Memorial Health SystemFort Myers, Florida  33901
Nemours Children's Clinic - OrlandoOrlando, Florida  32806
St. Vincent Indianapolis HospitalIndianapolis, Indiana  46260
Blank Children's HospitalDes Moines, Iowa  50309
Alvin and Lois Lapidus Cancer Institute at Sinai HospitalBaltimore, Maryland  21215
Breslin Cancer Center at Ingham Regional Medical CenterLansing, Michigan  48910
Hackensack University Medical Center Cancer CenterHackensack, New Jersey  07601
Albert Einstein Cancer Center at Albert Einstein College of MedicineBronx, New York  10461
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Methodist Children's Hospital of South TexasSan Antonio, Texas  78229-3993
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical CenterLos Angeles, California  90048-1865
Rady Children's Hospital - San DiegoSan Diego, California  92123-4282
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Alfred I. duPont Hospital for ChildrenWilmington, Delaware  19803
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston CampusAtlanta, Georgia  30322
MBCCOP - Medical College of Georgia Cancer CenterAugusta, Georgia  30912-3730
University of Illinois Cancer CenterChicago, Illinois  60612-7243
Keyser Family Cancer Center at Advocate Hope Children's HospitalOak Lawn, Illinois  60453
Lucille P. Markey Cancer Center at University of KentuckyLexington, Kentucky  40536-0093
Tulane Cancer Center Office of Clinical ResearchAlexandria, Louisiana  71315-3198
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer InstituteBoston, Massachusetts  02115
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Herbert Irving Comprehensive Cancer Center at Columbia University Medical CenterNew York, New York  10032
Akron Children's HospitalAkron, Ohio  44308-1062
Dayton Children's - DaytonDayton, Ohio  45404-1815
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Children's Hospital of Pittsburgh of UPMCPittsburgh, Pennsylvania  15213
Madigan Army Medical Center - TacomaTacoma, Washington  98431
Riley's Children Cancer Center at Riley Hospital for ChildrenIndianapolis, Indiana  46202-5225
Connecticut Children's Medical CenterHartford, Connecticut  06106
Nemours Children's Clinic - PensacolaPensacola, Florida  32504