The study aims to investigate whether prophylaxis with liposomal amphotericin B (AmBisome®) can reduce the incidence of invasive fungal infections (IFIs) in patients with Acute Lymphoblastic Leukemia (ALL) who are undergoing their first remission induction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
355
Ambisome 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week during induction chemotherapy
Placebo to match liposomal amphotericin B administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
Gilead Sciences
Cambridge, United Kingdom
Percentage of Participants With Proven or Probable IFIs During Remission-induction Chemotherapy for Acute Lymphoblastic Leukemia (ALL)
Diagnoses of proven or probable invasive fungal infections (IFI) were assessed according to European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) criteria by the independent data review board (IDRB) who were blinded to treatment assignment. The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy.
Time frame: During remission-induction chemotherapy (average 7 weeks)
Percentage of Participants With Pulmonary Infiltrates According to the Central Image Reader
Time frame: During remission-induction chemotherapy (average 7 weeks)
Percentage of Participants Diagnosed With Proven or Probable IFIs According to the EORTC/MSG Criteria, as Assessed by the Investigator
Time frame: During remission-induction chemotherapy (average 7 weeks)
Time to Diagnosis of Proven or Probable IFIs According to the EORTC/MSG Criteria, as Assessed by the IDRB.
Time to diagnosis of proven or probable IFIs is presented as the median (Q1,Q3) days to diagnosis of those participants who experienced a proven or probable IFI. Median was not reached if \< 50% of participants had an event; Q1 was not reached if \< 25% of participants had an event; Q3 was not reached if \< 75% of participants had an event.
Time frame: During remission-induction chemotherapy (average 7 weeks)
Percentage of Participants Requiring Antifungal Treatment During Remission-Induction Chemotherapy
Time frame: During remission-induction chemotherapy (average 7 weeks)
Percentage of Participants Who Died Due to Fungal Infection; Causality as Assessed by the IDRB.
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Time frame: During remission-induction chemotherapy (average 7 weeks)
Percentage of Participants Who Died Due to Fungal Infection; Causality as Assessed by the Investigator.
Time frame: During remission-induction chemotherapy (average 7 weeks)
Time From Beginning of Remission-induction Chemotherapy Until the Beginning of Consolidation Therapy
This endpoint was to evaluate the potential impact of IFI prevention on the efficacy of remission-induction chemotherapy for ALL.
Time frame: During remission-induction chemotherapy (average 7 weeks)
Percentage of Participants With Complete Remission at the End of Remission Induction
This endpoint was to evaluate the potential impact of IFI prevention on the efficacy of remission-induction chemotherapy for ALL.
Time frame: During remission-induction chemotherapy (average 7 weeks)