deltatrials
Terminated PHASE4 INTERVENTIONAL 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

Sponsor: Gilead Sciences

Updated 6 times since 2017 Last updated: Aug 20, 2007 Started: Nov 30, 2006 Completion: Sep 30, 2007
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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This PHASE4 trial investigates Fungal Infection and is currently terminated or withdrawn.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

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotTerminated~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotTerminated~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 19 months · monthly snapshotTerminated~Jan 2026 – present · 3 months · monthly snapshotTerminated

Change History

6 versions recorded
  1. Jan 2026 — Present [monthly]

    Terminated PHASE4

  2. Sep 2024 — Present [monthly]

    Terminated PHASE4

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE4

  4. Jan 2021 — Jul 2024 [monthly]

    Terminated PHASE4

  5. Jun 2018 — Jan 2021 [monthly]

    Terminated PHASE4

Show 1 earlier version
  1. 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

Sponsor contact:
  • Gilead Sciences
Data source: Gilead Sciences

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations