PROPHESSOR: AmBisome in Antifungal Primary Prophylaxis Treatment of High Risk Patients Undergoing Allogeneic Stem Cell Transplantation

NCT00326157 | Completed Phase 2

• 1 other identifier: GS-IT-131-0151
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study was designed in order to evaluate the safety and efficacy of an AmBisome® loading dose regimen, in a weekly administration schedule during the initial phase of allogeneic stem-cell transplant and in case of occurrence of graft versus host disease (GvHD), which are both high risk periods as far as severe fungal infection development is concerned.

Conditions

Fungus Diseases

Keywords

antifungal primary prophylaxis treatment; allogeneic stem-cell transplantation; antifungal primary prophylaxis treatment of high risk patients undergoing allogeneic stem-cell transplantation

Outcome Measures

Primary Outcomes (4)

• Safety and tolerability profile will be obtained by considering: Number (%) of patients with adverse events (AEs)

  Through 16 weeks

• Number (%) of patients with infusion related AE

  Through 16 weeks

• Laboratory parameters (in particular renal toxicity, hepatotoxicity, hypokalaemia, hypomagnesaemia)

  Through 16 weeks

• Overall adverse events

  Through 16 weeks

Secondary Outcomes (14)

• Number (%) of patients with probable or proven invasive fungal infection according to EORTC-MSG criteria within the 6 months following the initiation of prophylaxis treatment

  Within previous 6 months

• Number (%) of patients with fever of unknown origin requiring empirical antifungal treatment within the 6 months following the initiation of prophylaxis treatment

  Within previous 6 months

• Number (%) of patients with superficial fungal infections within the 6 months following the initiation of prophylaxis treatment

  Within previous 6 months

• Number (%) of patients with evidence of colonization by fungal organisms observed within the 6 months following the initiation of prophylaxis treatment

  Within previous 6 months

• Reasons for early study discontinuation

  Through 16 weeks

Study Arms (1)

1

EXPERIMENTAL

AmBisome® will be administered for a duration of 8 weeks

Drug: AmBisome

Interventions

AmBisome DRUG

3mg/kg/day three times a week until day 22 (21 days after transplantation day) and 7 mg/kg weekly from day 29 to the end of treatment (day 50-8th Week) of AmBisome®, IV administration

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged more than 18 years
• Patients with hematological malignancies undergoing allogeneic stem cell transplantation from donors other than human leukocyte antigen (HLA) identical sibling; source of stem cell includes either peripheral blood or bone marrow
• No evidence of fungal infection at chest computed tomography (CT) scan and at sinus X-ray at baseline
• Patients with no sign or symptoms of fungal infection and no previous proven or probable invasive fungal infection (IFI)
• Females of childbearing potential must be surgically incapable of pregnancy, or practising a method of birth control, or agree to abstain from heterosexual intercourse while participating in the study, and with a negative pregnancy test (blood or urine) at baseline
• An understanding of the study and agreement of the patient to give written informed consent
• Ability and agreement to comply with all study requirements
• Patient willing to attend hospital appointments for each injection (infusions will be performed in the hospital, under strict medical supervision). All patients will be hospitalised prior to, and remain in the hospital for at least one day, after the first infusion.

You may not qualify if:

• Known hypersensitivity to amphotericin B, in particular known history of anaphylactic reaction to amphotericin B
• Patients undergoing cord transplantation
• Creatinine \> 2.0 mg/dL
• Patient with moderate or severe liver disease as defined by AST or ALT \> 5 times the upper limit of normal (ULN)
• Patients who are unlikely to survive more than 1 month
• Any severe cardiovascular disease (such as arrhythmias, in particular) which may constitute a contra-indication to AmBisome® administration
• Pregnant or nursing females
• Patients previously included in this study

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (1)

Gilead Sciences

Milan, 20146, Italy

Location

MeSH Terms

Conditions

Mycoses

Interventions

liposomal amphotericin B

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Luigi Picaro, MD

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 10, 2006
• First Posted: May 16, 2006
• Study Start: June 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: November 1, 2009
• Last Updated: February 12, 2010

Record last verified: 2010-02

Locations

IT (1)