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

NCT ID: NCT00326157

Last Updated: 2010-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2009-11-30

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.

Detailed Description

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 GvHD, which are both high risk periods as far as severe fungal infection development is concerned.

Conditions

Fungus Diseases

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

AmBisome® will be administered for a duration of 8 weeks

Group Type: EXPERIMENTAL

AmBisome

Intervention Type: 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

Interventions

AmBisome

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

• Pregnant or nursing females
• Patients previously included in this study
• Patients who have taken any investigational drug in the last 30 days prior to the inclusion.

Exclusion Criteria

• 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
• Patients who have received systemic antifungal therapy within 15 days prior to the inclusion
• Any severe cardiovascular disease (such as arrhythmias, in particular) which may constitute a contra-indication to AmBisome® administration

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Gilead Sciences

Principal Investigators

Luigi Picaro, MD

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

Gilead Sciences

Milan, , Italy

Countries

Italy

Other Identifiers

GS-IT-131-0151

Identifier Type: -

Identifier Source: org_study_id