Daily IL-2 for Steroid-Refractory Chronic Graft-versus-Host-Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Prometheus Laboratories
Information provided by (Responsible Party):
John Koreth, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01366092
First received: June 2, 2011
Last updated: June 29, 2015
Last verified: June 2015
Results First Received: December 18, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Graft-versus-host Disease
Intervention: Drug: Interleukin-2

  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
Interleukin-2 Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus

Participant Flow:   Overall Study
    Interleukin-2  
STARTED     35  
COMPLETED     31  
NOT COMPLETED     4  
Progressive cGVHD                 2  
Physician Decision                 1  
Withdrawal by Subject                 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.
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Reporting Groups
  Description
Interleukin-2 Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus

Baseline Measures
    Interleukin-2  
Number of Participants  
[units: participants]
  35  
Age  
[units: years]
Median (Full Range)
  51   (22 to 72)  
Gender  
[units: participants]
 
Female     17  
Male     18  
Region of Enrollment  
[units: participants]
 
United States     35  
Time from Allogeneic Stem Cell Transplant  
[units: days]
Median (Full Range)
  616   (270 to 2145)  
Time from chronic GVHD onsent  
[units: days]
Median (Full Range)
  252   (28 to 1880)  
Number of cGVHD organ sites  
[units: organs affected by cGVHD]
Median (Full Range)
  4   (1 to 7)  
Number of concurrent cGVHD therapies  
[units: therapies]
Median (Full Range)
  2   (1 to 3)  
Baseline Corticosteroid (Prednisone) dose  
[units: milligrams per day]
Median (Full Range)
  20   (2.5 to 50)  



  Outcome Measures
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1.  Primary:   Overall Response Rate of Low-dose Daily SC IL-2 in Steroid-refractory cGVHD   [ Time Frame: Baseline, 6 weeks, and 12 weeks ]

2.  Secondary:   Toxicity of 12-week Course of Low-dose SC IL-2 Therapy   [ Time Frame: 12 weeks ]

3.  Secondary:   Prednisone Taper With IL-2 Therapy   [ Time Frame: End of treatment after 16 weeks or most recent follow-up date for patients on extended ]

4.  Secondary:   Overall Survival and Progression-free Survival   [ Time Frame: 2 years from start of IL-2 ]

5.  Secondary:   Immunologic Effects of Low-dose Daily SC IL-2: Treg Cell Counts   [ Time Frame: 16 weeks of study follow-up ]

6.  Secondary:   Immunologic Effects of Low-dose Daily SC IL-2: Treg/Tcon Ratio   [ Time Frame: 16 weeks of study follow-up ]


  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: John Koreth, MBBS, DPhil
Organization: Dana-Farber Cancer Institute
phone: 617-632-2949
e-mail: JKoreth@partners.org


No publications provided


Responsible Party: John Koreth, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01366092     History of Changes
Other Study ID Numbers: 11-149, P01CA142106
Study First Received: June 2, 2011
Results First Received: December 18, 2014
Last Updated: June 29, 2015
Health Authority: United States: Food and Drug Administration