Ultra-Low Dose Interleukin-2 for Refractory Chronic Graft Versus Host Disease

This study has been completed.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Novartis
Information provided by (Responsible Party):
John Koreth, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00529035
First received: September 11, 2007
Last updated: February 10, 2014
Last verified: February 2014
Results First Received: August 9, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: 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
Ultra-low Dose Interleukin-2

Daily subcutaneous administration of Interleukin-2 evaluated at three dose levels:

Dose level A: 0.3 x 10^6 IU/m^2/day Dose level B: 1.0 x 10^6 IU/m^2/day Dose level C: 3.0 x 10^6 IU/M^2/day


Participant Flow:   Overall Study
    Ultra-low Dose Interleukin-2  
STARTED     29 [1]
COMPLETED     28 [2]
NOT COMPLETED     1  
Withdrawal by Subject                 1  
[1] 29 enrolled
[2] 28 evaluable, 1 patient withdrew participation and was not evaluable



  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
Group 1 No text entered.

Baseline Measures
    Group 1  
Number of Participants  
[units: participants]
  29  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     29  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  46.5  ± 12.7  
Gender  
[units: participants]
 
Female     8  
Male     21  
Region of Enrollment  
[units: participants]
 
United States     29  



  Outcome Measures
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1.  Primary:   The Maximum Tolerated Dose and Toxicity Profile of an 8 Week Course of IL-2 in Patients With cGVHD and an Inadequate Response to Steroids.   [ Time Frame: Participants were assessed for toxicities at mandatory study follow-up visits during the 8 week course of study therapy and four weeks post therapy ]

2.  Secondary:   The Number of Participants Who Tolerated at Least 6 Weeks of Subcutaneous Low Dose IL-2.   [ Time Frame: Participants were assessed for toxicities at mandatory study follow-up visits during the 8 week course of study therapy and four weeks post therapy. cGVHD was assessed at Weeks 8 and 12 ]

3.  Secondary:   CD3+T, CD4+T (Including Regulatory CD4+T Cells (Treg) and Conventional CD4+T Cells (Tcon)), CD8+T, NK, NKT and B Cell Counts.   [ Time Frame: Immunological samples taken at study appointments during the 12 week protocol schedule ]

4.  Secondary:   Treg Cell:Tcon Cell Ratio   [ Time Frame: Immunological samples taken at study appointments during the 12 week protocol schedule ]


  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: John Koreth, MBBS, D.Phil
Organization: Dana-Farber Cancer Institute
phone: (617) 632-2949
e-mail: jkoreth@partners.org


Publications of Results:

Responsible Party: John Koreth, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00529035     History of Changes
Other Study ID Numbers: 07-083
Study First Received: September 11, 2007
Results First Received: August 9, 2012
Last Updated: February 10, 2014
Health Authority: United States: Institutional Review Board