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Interleukin-7 (CYT107) Treatment of Idiopathic CD4 Lymphocytopenia: Expansion of CD4 T Cells (ICICLE)

This study has been terminated.
(Bankruptcy of Drug manufacturer: Drug not available)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier:
NCT00839436
First received: February 6, 2009
Last updated: October 14, 2015
Last verified: October 2015
Results First Received: October 14, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Idiopathic CD4+ T-Lymphocytopenia
Intervention: Drug: CYT107

  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
No text entered.

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
3 mcg/kg Cohort No text entered.
10 mcg/kg Cohort No text entered.
20 mcg/kg Cohort No text entered.

Participant Flow:   Overall Study
    3 mcg/kg Cohort     10 mcg/kg Cohort     20 mcg/kg Cohort  
STARTED     3     5     1  
COMPLETED     2     4     0  
NOT COMPLETED     1     1     1  
Developed exclusionary condition                 1                 0                 0  
Withdrawal by Subject                 0                 1                 0  
Study drug no longer available                 0                 0                 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.
No text entered.

Reporting Groups
  Description
3 mcg/kg Cohort No text entered.
10 mcg/kg Cohort No text entered.
20 mcg/kg Cohort No text entered.
Total Total of all reporting groups

Baseline Measures
    3 mcg/kg Cohort     10 mcg/kg Cohort     20 mcg/kg Cohort     Total  
Number of Participants  
[units: participants]
  3     5     1     9  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     3     4     1     8  
>=65 years     0     1     0     1  
Age  
[units: years]
Median (Inter-Quartile Range)
  49  
  (23 to 51)  
  56  
  (44.5 to 63.5)  
  33  
  (33 to 33)  
  51  
  (33.5 to 56.5)  
Gender  
[units: participants]
       
Female     3     3     1     7  
Male     0     2     0     2  
Region of Enrollment  
[units: participants]
       
United States     3     5     1     9  
CD4 T cell count  
[units: cells/microliter]
Median (Inter-Quartile Range)
  13  
  (10 to 18)  
  52  
  (20 to 183.5)  
  15  
  (15 to 15)  
  18  
  (14 to 116)  



  Outcome Measures

1.  Primary:   Adverse Events and Toxicities Associated With CYT107.   [ Time Frame: 48 weeks per patient with a 3-4 year enrollment period ]

2.  Other Pre-specified:   Change: CD4/CD8 T Cell Cts After CYT107; in Immunophenotype (Naive, Memory, Regulatory T Cell Subsets) & Amp; Antigen-specific T Cell Function After CYT107; in T Cell Activation/Proliferation Status & Amp; TCR Repertoire After CYT107; ...   [ Time Frame: 48 weeks per patient with a 3-4 year enrollment period ]
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
No text entered.


  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. Virginia Sheikh
Organization: NIAID
phone: 3014357939
e-mail: sheikhv@niaid.nih.gov


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT00839436     History of Changes
Other Study ID Numbers: 090069
09-I-0069
Study First Received: February 6, 2009
Results First Received: October 14, 2015
Last Updated: October 14, 2015
Health Authority: United States: Food and Drug Administration