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
Sponsor: Gilead Sciences
Terminated
Study closed due to recruitment challenges.
This PHASE4 trial investigates Fungal Infection and is currently terminated or withdrawn. Gilead Sciences leads this study, which shows 6 recorded versions since 2006 — indicating limited longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.
Study Description(click to expand)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®.
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®.
Status Flow
Change History
6 versions recorded-
Jan 2026 — Present [monthly]
Terminated PHASE4
-
Sep 2024 — Present [monthly]
Terminated PHASE4
-
Jul 2024 — Sep 2024 [monthly]
Terminated PHASE4
-
Jan 2021 — Jul 2024 [monthly]
Terminated PHASE4
-
Jun 2018 — Jan 2021 [monthly]
Terminated PHASE4
▶ Show 1 earlier version
-
Jan 2017 — Jun 2018 [monthly]
Terminated PHASE4
First recorded
Nov 2006
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Gilead Sciences
For direct contact, visit the study record on ClinicalTrials.gov .