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PROPHESSOR: AmBisome in Antifungal Primary Prophylaxis Treatment of High Risk Patients Undergoing Allogeneic Stem Cell Transplantation
This study has been completed.
Study NCT00326157   Information provided by Gilead Sciences
First Received: May 10, 2006   Last Updated: February 11, 2010   History of Changes

May 10, 2006
February 11, 2010
June 2006
January 2009   (final data collection date for primary outcome measure)
  • Safety and tolerability profile will be obtained by considering: Number (%) of patients with adverse events (AEs) [ Time Frame: Through 16 weeks ] [ Designated as safety issue: No ]
  • Number (%) of patients with infusion related AE [ Time Frame: Through 16 weeks ] [ Designated as safety issue: No ]
  • Laboratory parameters (in particular renal toxicity, hepatotoxicity, hypokalaemia, hypomagnesaemia) [ Time Frame: Through 16 weeks ] [ Designated as safety issue: No ]
  • Overall adverse events [ Time Frame: Through 16 weeks ] [ Designated as safety issue: No ]
  • Safety and tolerability profile will be obtained by considering:
  • Number (%) of patients with Infusion related AEs,
  • Laboratory Parameters (in particular Renal toxicity, hepatotoxicity, hypokalaemia, hypomagnesaemia),
  • Overall Adverse Events.
  • Number (%) of patients with adverse events (AEs)
Complete list of historical versions of study NCT00326157 on ClinicalTrials.gov Archive Site
  • 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 [ Time Frame: Within previous 6 months ] [ Designated as safety issue: No ]
  • Number (%) of patients with fever of unknown origin requiring empirical antifungal treatment within the 6 months following the initiation of prophylaxis treatment [ Time Frame: Within previous 6 months ] [ Designated as safety issue: No ]
  • Number (%) of patients with superficial fungal infections within the 6 months following the initiation of prophylaxis treatment [ Time Frame: Within previous 6 months ] [ Designated as safety issue: No ]
  • Number (%) of patients with evidence of colonization by fungal organisms observed within the 6 months following the initiation of prophylaxis treatment [ Time Frame: Within previous 6 months ] [ Designated as safety issue: No ]
  • Reasons for early study discontinuation [ Time Frame: Through 16 weeks ] [ Designated as safety issue: No ]
  • Survival rate and incidence of mortality related to fungal infection at the end of treatment and within 3, 6, and 12 months after the initiation of prophylaxis treatment [ Time Frame: Within 12 months ] [ Designated as safety issue: No ]
  • Time to probable or proven invasive fungal infection; fever of unknown origin requiring empirical antifungal treatment [ Time Frame: Through 16 weeks ] [ Designated as safety issue: No ]
  • Time to superficial fungal infections [ Time Frame: Through 16 weeks ] [ Designated as safety issue: No ]
  • Time to initiation of empirical antifungal treatment [ Time Frame: Through 16 weeks ] [ Designated as safety issue: No ]
  • Time to study discontinuation [ Time Frame: Through 16 weeks ] [ Designated as safety issue: No ]
  • Number of patients enrolled [ Time Frame: Through 16 weeks ] [ Designated as safety issue: No ]
  • Number of patients completing the study [ Time Frame: Through 16 weeks ] [ Designated as safety issue: No ]
  • Number of patients with early discontinuation [ Time Frame: Through 16 weeks ] [ Designated as safety issue: No ]
  • Number of patients classified by reason for discontinuing study drug (including the study completion) [ Time Frame: Through 16 weeks ] [ Designated as safety issue: No ]
  • Other objectives of the trial will be be met by:
  • 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.
  • Number (%) of patients with fever of unknown origin requiring empirical antifungal treatment within the 6 months following the initiation of prophylaxis treatment.
  • Number (%) of patients with superficial fungal infections within the 6 months following the initiation of prophylaxis treatment.
  • Number (%) of patients with evidence of colonization by fungal organisms observed within the 6 months following the initiation of prophylaxis treatment. .
  • Reasons for early study discontinuation
  • Survival rate and incidence of mortality related to fungal infection at the end of treatment and within 3, 6 and 12 months after the initiation of prophylaxis treatment
  • Time to the following events may also be considered: probable or proven invasive fungal infection; fever of unknown origin requiring empirical antifungal treatment superficial fungal infections initiation of empirical antifungal treatment
  • study discontinuation.
  • Patients disposition
  • Number of patients enrolled
  • Number of patients completing the study
  • Number of patients with early discontinuation
  • Number of patients classified by reason for discontinuing study drug (including the study completion).
 
PROPHESSOR: AmBisome in Antifungal Primary Prophylaxis Treatment of High Risk Patients Undergoing Allogeneic Stem Cell Transplantation
Phase II Pilot Study on Safety of Administration of 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® in Antifungal Primary Prophylaxis Treatment of High Risk Patients Undergoing Allogeneic Stem-cell Transplantation

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.

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.

Phase II
Interventional
Allocation:  Non-Randomized
Control:  Uncontrolled
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Single Group Assignment
Masking:  Open Label
Primary Purpose:  Prevention
Fungus Diseases
Drug: 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
1: Experimental
AmBisome® will be administered for a duration of 8 weeks
Intervention: Drug: AmBisome
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
34
November 2009
January 2009   (final data collection date for primary outcome measure)

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.

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
  • Any severe disease other than the hematological diseases described at the second point of inclusion criteria, which in the investigator's judgement may interfere with study evaluations or affect the patient's safety
  • 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00326157
Luigi Antonio Picaro, Gilead Sciences
GS-IT-131-0151
Gilead Sciences
 
Study Director: Luigi Picaro, MD Gilead Sciences
Gilead Sciences
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP