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

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ClinicalTrials.gov Identifier: NCT00075803
Recruitment Status : Completed
First Posted : January 13, 2004
Results First Posted : September 4, 2015
Last Update Posted : September 12, 2016
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Blood and Marrow Transplant Clinical Trials Network
National Cancer Institute (NCI)
National Marrow Donor Program
Information provided by (Responsible Party):
Medical College of Wisconsin

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Lymphoma
Infection
Leukemia
Interventions: Drug: Fluconazole
Drug: Voriconazole

  Participant Flow

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

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 
Overall Participants Analyzed 
[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 
[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.
Karnofsky/Lansky Performance Status [1] 
[Units: Participants]
 		     
90% - 100%   249   268   517 
< 90%   46   37   83 
[1] 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

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 ]
  Show Outcome Measure 1

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

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

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

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

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

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

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

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

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

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 ]
  Show Outcome Measure 11

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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 ( U.S. NIH Grant/Contract )
5U24CA076518 ( U.S. NIH Grant/Contract )
First Submitted: January 9, 2004
First Posted: January 13, 2004
Results First Submitted: February 22, 2013
Results First Posted: September 4, 2015
Last Update Posted: September 12, 2016