Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01371656 · ClinicalTrials.gov registry record · Phase 3

Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation

A Phase 3 study, sponsored by Children's Oncology Group.

Completed
Registry status
Phase 3
Development phase
624
Enrollment target

NCT01371656: Completed Phase 3 study, sponsored by Children's Oncology Group.

NCT01371656 is a Phase 3 study that has completed, run by Children's Oncology Group. The registered enrollment target is 624 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01371656, a Phase 3 study, has completed, sponsored by Children's Oncology Group.

COMPLETED
Registry status
Phase 3
Development phase
624 participants
Enrollment target

Study 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.

Primary Outcome

A bacteremia incidence is defined as an occurrence of at least 1 episode of true (centrally reviewed) bacteremia among Acute Leukemia (AL) and Hematopoietic stem cell transplantation (HSCT) patients.

Interventions

  • DRUG levofloxacin

Trial Details

FieldValue
Enrollment Target 624 participants
Start Date 2011-09
Est. Completion 2017-06
Phase Phase 3
Children's Oncology Group

342 total trials

What the finished NCT01371656 record still lists

NCT01371656 is an interventional study that assigns participants to a tested intervention. The registered 624 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% lower).

The record links to 0 conditions, and to 1 intervention - of which levofloxacin is the first listed.

NCT01371656 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01371656 about?

NCT01371656 is a clinical study titled "Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation". 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 chemothe...

What is the current status of trial NCT01371656?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 624 participants. The study started on 2011-09. Estimated completion is 2017-06.

What interventions are being tested in trial NCT01371656?

The interventions under investigation include: levofloxacin (DRUG).

Who is sponsoring clinical trial NCT01371656?

This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01371656's enrollment target sits among peer trials

624 587th of 2000 higher than 1,413 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT06406049 · 624 participants · NA

    Finishing HIV Project

  • NCT05349227 · 625 participants · NA

    Comprehensive Outcomes for After Cancer Health

  • NCT06103864 · 625 participants · Phase 3

    A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer

  • NCT06230510 · 625 participants · NA

    Milk-Tot Study: Impact of Whole Versus Low-fat Milk on Child Health

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT01371656, the US trial registry maintained by the National Library of Medicine. NCT01371656 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.