At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 624 enrolled
Drug / intervention
levofloxacindrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Trial of Levofloxacin to Prevent Bacteremia in Children Being Treated for Acute Leukemia (AL) or Undergoing Hematopoietic Stem Cell Transplantation (HSCT)
In Brief
A Phase 3 clinical trial evaluating levofloxacin for Acute Leukemias of Ambiguous Lineage and 9 related conditions. Completed, enrolled 624 participants across 84 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
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
CountriesCanada, United States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 2011
Enrollment StartSep 2011
Primary CompletionJun 2017
TodayJul 2026
First PostedJun 13, 2011
Enrollment StartSep 1, 2011
Primary CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 15.1 years ago
Interventions
levofloxacindrug
Given PO or IV