ProphyALL - Pilot Study on Safety of Four Weekly Administrations of 7 mg/kg of Liposomal Amphotericin B (AmBisome®) in Antifungal Primary Prophylaxis Treatment of Elderly Patients With Acute Lymphoblastic Leukemia Undergoing Induction Chemotherapy Within the GMALL-Elderly Protocol
This is a multi-center, pilot, prospective, open label study. Approximately 20 patients will
be recruited in 10 to 15 centers.
The patient group will be the following:
Elderly patients (≥ 55 years) with acute lymphoblastic leukemia undergoing chemotherapy with
GMALL-Elderly 1/2003 protocol.
They will be treated with LAMB for four weeks after induction phase I. Patients will attend
for full assessment until trial completion or withdrawal: there will be 3 assessment visits
during the first week, 2 assessment visits during the second week, and 1 weekly assessment
visit during the third and fourth week of the prophylaxis treatment (the first visit of each
week being the infusion visit as well).
After the end of the prophylaxis period, patients will have 3 follow-up visits which will be
scheduled at Weeks 6, 9, and 12.
Please note that no other systemic antifungal prophylaxis is allowed to be used
concomitantly with AmBisome®.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
To characterize the safety profile of a prophylactic antifungal LAMB treatment of
Gilead Sciences GmbH
Germany: Federal Institute for Drugs and Medical Devices