Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
AmBiGuard: AmBisome Prophylaxis in ALL
NCT01259713Phase 3
Key facts
- Status
- Completed
- Start
- Apr 2011
- Primary completion
- Dec 2013
- Countries
- 1
- Sponsor
- Gilead Sciences
- Modality
- Lipid-based Nanoparticles, Small Molecules
- Conditions
- invasive fungal infection (IFI)
01
Overview
Phase 3, randomised, double-blind trial in invasive fungal infection (IFI) comparing Liposomal amphotericin B with Placebo (2 arms). Primary endpoint: Percentage of Participants With Proven or Probable Invasive Fungal Infections. Started Apr 2011; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Liposomal amphotericin B
AmBisome 5 mg/kg IV twice weekly
Placebo
Placebo IV twice weekly
03
Who it enrols
Adult patients with newly diagnosed ALL receiving induction chemotherapy expected to cause neutropenia for at least 10 days. Patients with prior fungal infections or severe liver/kidney dysfunction are excluded.
04
Endpoints
Primary
Percentage of Participants With Proven or Probable Invasive Fungal Infections
Secondary
Percentage of Participants With Pulmonary Infiltrates
Percentage of Participants Diagnosed With Proven or Probable IFIs According to the EORTC/MSG Criteria, as Assessed by the Investigator
Time to Diagnosis of Proven or Probable IFIs
Percentage of Participants Requiring Antifungal Treatment
Percentage of Participants Who Died Due to Fungal Infection
Time From Beginning of Remission-induction Chemotherapy Until the Beginning of Consolidation Therapy
Percentage of Participants With Complete Remission at the End of Remission Induction
05
Results
Not all primary endpoints met
Beyond the preview
Go deeper on NCT01259713.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT01259713.