Prevention of Invasive Fungal Infections (IFIs) in Subjects Receiving Chemotherapy for Acute Lymphoblastic Leukemia

PHASE3CompletedINTERVENTIONAL
Enrollment

355

Participants

Timeline

Start Date

April 30, 2011

Primary Completion Date

December 31, 2013

Study Completion Date

January 31, 2014

Conditions
Invasive Fungal Disease
Interventions
DRUG

Liposomal amphotericin B

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

DRUG

Placebo

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

Trial Locations (1)

CB21 6GT

Gilead Sciences, Cambridge

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY