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Type(s) of Cancer
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
Study Phase
Phase 3
Study Completion Date
June 2017
NCT01371656Uploaded 11-24-2020
Access via NCI by Request
PDS UID: nci-data-437
A Randomized Trial of Levofloxacin to Prevent Bacteremia in Children Being Treated for Acute Leukemia (AL) or Undergoing Hematopoietic Stem Cell Transplantation (HSCT)
Provider Information
Provider Data DescriptionThere are six datasets associated with PubMed ID 30208456 (NCT01371656-D1 through -D6). NCT01371656-D1 provides the information for the consort diagram (Figure 1). Data provided on all enrolled patients (N=624). There is one row per patient.
SponsorN/A
Data ProviderN/A
Partial set or SubsetN/A
Patients in dataset0
# of Patients Control0
# of Patients ExperimentalNA
DOIN/A
CDISC StandardNA
Study ArmsUndefined
Clinical Trials.gov Information
Brief SummaryThis 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.
ConditionsAcute 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
Intervention TypeDrug: levofloxacin
Drug(s)Drug: levofloxacin
Total Enrolled624
RandomizationRandomized
Blinding MethodSingle
Arms InterventionArm I (levofloxacin) - Experimental
Arm II (standard of care) - No Intervention
Secondary IDNCI-2011-02636
PubMed (PMID)NA
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Canada
Age RangeMinimum Age: 6 Months
Maximum Age: 21 Years
Files: NCT01371656-D1
Data DictionaryNCT01371656-D1-Data-Dictionary_5.pdf
DATANCT01371656-D1-Dataset_3.CSV
OTHERREADME.pdf
Files: NCT01371656-D2
Data DictionaryNCT01371656-D2-Data-Dictionary_5.pdf
DATANCT01371656-D2-Dataset_3.CSV
OTHERREADME.pdf
Files: NCT01371656-D3
Data DictionaryNCT01371656-D3-Data-Dictionary_3.pdf
DATANCT01371656-D3-Dataset_2.CSV
OTHERREADME.pdf
Files: NCT01371656-D4
Data DictionaryNCT01371656-D4-Data-Dictionary_3.pdf
DATANCT01371656-D4-Dataset_2.CSV
OTHERREADME.pdf
Files: NCT01371656-D5
Data DictionaryNCT01371656-D5-Data-Dictionary_2.pdf
DATANCT01371656-D5-Dataset_1.CSV
OTHERREADME.pdf
Files: NCT01371656-D6
Data DictionaryNCT01371656-D6-Data-Dictionary_1.pdf
DATANCT01371656-D6-Dataset_1.CSV
OTHERREADME.pdf
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