Comparison of Fluconazole vs Voriconazole to Treat Fungal Infections for Blood and Marrow Transplants (BMT CTN 0101)

This study has been completed.
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Blood and Marrow Transplant Clinical Trials Network
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00075803
First received: January 9, 2004
Last updated: August 5, 2015
Last verified: August 2015
Results First Received: February 22, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Lymphoma
Infection
Leukemia
Interventions: Drug: Fluconazole
Drug: Voriconazole

  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
Participants were enrolled from November 2003 through September 2006

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Fluconazole fluconazole prophylaxis
Voriconazole voriconazole prophylaxis

Participant Flow:   Overall Study
    Fluconazole     Voriconazole  
STARTED     295     305  
COMPLETED     295     305  
NOT COMPLETED     0     0  



  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.
No text entered.

Reporting Groups
  Description
Fluconazole fluconazole prophylaxis
Voriconazole voriconazole prophylaxis
Total Total of all reporting groups

Baseline Measures
    Fluconazole     Voriconazole     Total  
Number of Participants  
[units: participants]
  295     305     600  
Age, Customized  
[units: years]
Median (Full Range)
  43  
  (9 to 65)  
  43  
  (3 to 66)  
  43  
  (3 to 66)  
Age, Customized  
[units: participants]
     
<18 years     24     27     51  
≥18 years     271     278     549  
Gender  
[units: participants]
     
Female     134     135     269  
Male     161     170     331  
Race/Ethnicity, Customized  
[units: participants]
     
White     265     276     541  
Other     30     29     59  
Graft Source  
[units: participants]
     
Bone marrow     109     106     215  
Peripheral blood     186     197     383  
Cord blood     0     2     2  
Primary Disease  
[units: participants]
     
Acute myeloid leukemia     101     133     234  
Acute lymphoblastic leukemia     64     58     122  
Chronic myelogenous leukemia     60     43     103  
Myelodysplastic syndrome     49     49     98  
Non-Hodgkin lymphoma     21     22     43  
Human Leukocyte Antigen (HLA) Match [1]
[units: participants]
     
6 of 6     282     293     575  
5 of 6     13     12     25  
Karnofsky/Lansky Performance Status [2]
[units: participants]
     
90% - 100%     249     268     517  
< 90%     46     37     83  
[1] Patients must have a 5 or 6 of 6 HLA-matched donor. The match may be determined at serologic level for HLA-A and HLA-B loci.
[2] Assesses patient self-perceived global quality of life and functioning (excellent, very good, good, fair, poor), where 100 equals perfect quality of life.



  Outcome Measures
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1.  Primary:   Fungal-free Survival (Percentage of Participants Alive and Free From Proven, Probable, or Presumptive Invasive Fungal Infection) at 180 Days Post-transplant   [ Time Frame: 180 days ]

2.  Secondary:   Frequency of Invasive Fungal Infections (IFI)   [ Time Frame: 1 year ]

3.  Secondary:   Percentage of Patients With Invasive Fungal Infection at 100, 180, and 365 Days   [ Time Frame: 100, 180, and 365 days ]

4.  Secondary:   Overall Survival   [ Time Frame: 100, 180, and 365 days ]

5.  Secondary:   Relapse Free Survival   [ Time Frame: 100, 180, and 365 days ]

6.  Secondary:   Frequency of Use of Amphotericin B or Caspofungin   [ Time Frame: 1 year ]

7.  Secondary:   Duration of Use of Amphotericin B or Caspofungin   [ Time Frame: 180 days ]

8.  Secondary:   Time to and Severity of Acute and Chronic Graft vs Host Disease (GVHD)   [ Time Frame: 100 and 365 days ]

9.  Secondary:   Utility of Galactomannan Assay in Diagnosis of Aspergillus and Response to Therapy   [ Time Frame: 1 year ]

10.  Secondary:   Failure to Engraft   [ Time Frame: day 42 ]

11.  Secondary:   Freedom From Possible, Presumptive, Probable, or Proven Invasive Fungal Infection, Death, or Withdrawal of Study Drug Due to Toxicity, Intolerance, or an Empirical Trial of Amphotericin B or Caspofungin Greater Than 14 Consecutive Days   [ Time Frame: 1 year ]

12.  Secondary:   Time to Neutrophil Engraftment   [ Time Frame: 28 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

13.  Secondary:   Time to Platelet Engraftment   [ Time Frame: 180 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Nancy DiFronzo, PhD
Organization: NHLBI
phone: 301-435-0065
e-mail: difronozon@nhlbi.nih.gov


Publications of Results:

Responsible Party: Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00075803     History of Changes
Obsolete Identifiers: NCT00322088
Other Study ID Numbers: BMTCTN0101
BMT CTN 0101 ( Other Identifier: Blood and Marrow Transplant Clinical Trial Network )
U01HL069294 ( US NIH Grant/Contract Award Number )
Study First Received: January 9, 2004
Results First Received: February 22, 2013
Last Updated: August 5, 2015
Health Authority: United States: Federal Government
United States: Food and Drug Administration