NCT00386997

ProphyALL - Study on the Safety of Liposomal Amphotericin B to Prevent Antifungal Infections in Elderly Patients With Acute Lymphoblastic Leukemia

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

Due to the poor outcome of patients with invasive fungal infections (IFI), a more effective prevention of these infections in such patients is wanted. These experiences in intensively treated elderly patients with acute leukemia are especially worrying. This pilot study is designed to collect information on the safety (and efficacy) of an antifungal preventative therapy with an AmBisome® loading dose regimen of 7 mg/kg/week, in four weekly administrations, during the aplastic phase following the start of chemotherapy for acute lymphoblastic leukemia in elderly patients, which is a high risk period for severe fungal infections.

Detailed description

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®.

Conditions

• Fungal Infection

Interventions

Type	Name	Description
DRUG	liposomal amphotericin B (AmBisome®)

Timeline

• Start date: 2006-11-01
• Completion: 2007-09-01
• First posted: 2006-10-12
• Last updated: 2007-08-21

Locations

1 site across 1 country: Germany