Effect of Cyclosporine Therapy on Gene Expression in Patients With Large Granular Lymphocyte Leukemia

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00363779
First received: August 10, 2006
Last updated: July 6, 2012
Last verified: July 2012
Results First Received: March 30, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Large Granular Lymphocytic Leukemia
LGL Leukemia
Interventions: Drug: Cyclosporine
Genetic: Gene expression analysis
Genetic: Microarray analysis
Other: Laboratory biomarker analysis

  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
LGL Patients Administered Cyclosporine Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.

Participant Flow:   Overall Study
    LGL Patients Administered Cyclosporine  
STARTED     5  
COMPLETED     5  
NOT COMPLETED     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.
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Reporting Groups
  Description
LGL Patients Administered Cyclosporine Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.

Baseline Measures
    LGL Patients Administered Cyclosporine  
Number of Participants  
[units: participants]
  5  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     2  
>=65 years     3  
Age  
[units: years]
Mean ± Standard Deviation
  67.7  ± 6.09  
Gender  
[units: participants]
 
Female     0  
Male     5  
Ethnicity (NIH/OMB)  
[units: Participants]
 
Hispanic or Latino     0  
Not Hispanic or Latino     5  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: Participants]
 
American Indian or Alaska Native     0  
Asian     1  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     4  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     5  



  Outcome Measures
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1.  Primary:   Changes in Gene Expression Patterns   [ Time Frame: Baseline and 12 weeks ]

2.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 3 months ]


  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: Kevin Conlon, M.D.
Organization: National Cancer Institute (NCI), National Institutes of Health (NIH)
phone: 301-496-7417
e-mail: conlonkc@mail.nih.gov


Publications:

Responsible Party: John E. Janik, M.D./National Cancer Institute, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00363779     History of Changes
Other Study ID Numbers: 060177, 06-C-0177
Study First Received: August 10, 2006
Results First Received: March 30, 2012
Last Updated: July 6, 2012
Health Authority: United States: Federal Government