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Posaconazole Versus Micafungin for Prophylaxis Against Invasive Fungal Infections During Neutropenia in Patients Undergoing Chemotherapy for Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia or Myelodysplastic Syndrome

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01200355
First Posted: September 13, 2010
Last Update Posted: September 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
Results First Submitted: May 5, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Acute Myelogenous Leukemia
Myelodysplastic Syndrome
Interventions: Drug: micafungin
Drug: posaconazole

  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
Protocol Open to Accrual 09/09/2010 Protocol Closed to Accrual 04/20/2016 Primary Completion Date 04/20/2016 Recruitment Location is the medical clinic

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
Micafungin

This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).

micafungin: Micafungin 100 mg intravenously once daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy.

Posaconazole

This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).

posaconazole: Posaconazole 400 mg orally twice daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy.


Participant Flow:   Overall Study
    Micafungin   Posaconazole
STARTED   58   55 
COMPLETED   51   53 
NOT COMPLETED   7   2 
Death                7                2 



  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
Micafungin

This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).

micafungin: Micafungin 100 mg intravenously once daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy.

Posaconazole

This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).

posaconazole: Posaconazole 400 mg orally twice daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy.

Total Total of all reporting groups

Baseline Measures
   Micafungin   Posaconazole   Total 
Overall Participants Analyzed 
[Units: Participants]
 58   55   113 
Age 
[Units: Years]
Median (Full Range)
 61 
 (32 to 75) 
 59 
 (26 to 74) 
 61 
 (32 to 75) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      25  43.1%      26  47.3%      51  45.1% 
Male      33  56.9%      29  52.7%      62  54.9% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      1   1.7%      5   9.1%      6   5.3% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      6  10.3%      3   5.5%      9   8.0% 
White      50  86.2%      43  78.2%      93  82.3% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      1   1.7%      4   7.3%      5   4.4% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   58   55   113 


  Outcome Measures
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1.  Primary:   Time to Failure   [ Time Frame: 2 years ]

2.  Secondary:   To Compare the Number of Days on Study Drug Between Patients Who Receive Posaconazole and Patients Who Receive Micafungin.   [ Time Frame: 2 years ]

3.  Secondary:   To Compare the Incidence of Possible, Probable or Proven Invasive Fungal Infections Between Patients Who Receive Posaconazole and Those Who Receive Micafungin During Treatment Phase   [ Time Frame: 2 years ]

4.  Secondary:   Prophylaxis Failure of Study Medication for Any Reason Between Patients Who Receive Posaconazole and Those Who Receive Micafungin.   [ Time Frame: 2 years ]

5.  Secondary:   To Compare Overall Survival Rates at 6 Weeks   [ Time Frame: 6 weeks from randomization between the two treatment arms. ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Genovefa Papanicolaou MD
Organization: Memorial Sloan Kettering Cancer Center
phone: 212-639-8361
e-mail: papanicg@mskcc.org



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01200355     History of Changes
Other Study ID Numbers: 10-038
First Submitted: September 9, 2010
First Posted: September 13, 2010
Results First Submitted: May 5, 2017
Results First Posted: July 24, 2017
Last Update Posted: September 27, 2017