The Deferasirox-AmBisome Therapy for Mucormycosis (DEFEAT Mucor) Study

This study has been completed.
Sponsor:
Collaborators:
Gilead Sciences
Astellas Pharma Inc
Novartis
Information provided by (Responsible Party):
Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier:
NCT00419770
First received: January 5, 2007
Last updated: September 2, 2011
Last verified: August 2011
Results First Received: June 29, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Mucormycosis
Interventions: Drug: deferasirox
Drug: Placebo
Drug: Liposomal amphotericin B

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Deferasirox Deferasirox plus liposomal amphotericin
Placebo Placebo control plus background liposomal amphotericin

Participant Flow:   Overall Study
    Deferasirox     Placebo  
STARTED     11     9  
COMPLETED     6     8  
NOT COMPLETED     5     1  
Withdrawal by Subject                 5                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Deferasirox Deferasirox plus liposomal amphotericin
Placebo Placebo control plus background liposomal amphotericin
Total Total of all reporting groups

Baseline Measures
    Deferasirox     Placebo     Total  
Number of Participants  
[units: participants]
  11     9     20  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     8     7     15  
>=65 years     3     2     5  
Age  
[units: years]
Median ( Full Range )
  59  
  ( 30 to 71 )  
  47  
  ( 40 to 75 )  
  52  
  ( 30 to 75 )  
Gender  
[units: participants]
     
Female     2     3     5  
Male     9     6     15  
Region of Enrollment  
[units: participants]
     
United States     11     9     20  



  Outcome Measures

1.  Primary:   Total Adverse Events   [ Time Frame: 30 Days After End of Therapy ]

2.  Primary:   Safety and Tolerability of Adjunctive Deferasirox Therapy in Patients Being Treated With LAmB for Mucormycosis   [ Time Frame: 14 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

3.  Primary:   Global Response Rate (Composite of Clinical and Radiographic Response) at End of Study Drug Administration, as Determined by a Blinded Adjudication Committee   [ Time Frame: 14 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Deferasirox Pharmacokinetic and Pharmacodynamic Parameters   [ Time Frame: 7 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Survival, Radiographic Improvement, Clinical Response, Time to Survival, Deferasirox vs. Free Iron Level Correlation   [ Time Frame: Up to 90 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information