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

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.
ClinicalTrials.gov Identifier: NCT00529035
Recruitment Status : Active, not recruiting
First Posted : September 14, 2007
Results First Posted : January 29, 2014
Last Update Posted : November 6, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Graft Versus Host Disease
Intervention: Drug: Interleukin-2

  Participant Flow

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
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

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
Group 1 No text entered.

Baseline Measures
   Group 1 
Overall Participants Analyzed 
[Units: Participants]
 29 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      29 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 46.5  (12.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      8  27.6% 
Male      21  72.4% 
Region of Enrollment 
[Units: Participants]
 
United States   29 


  Outcome Measures

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

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

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
First Submitted: September 11, 2007
First Posted: September 14, 2007
Results First Submitted: August 9, 2012
Results First Posted: January 29, 2014
Last Update Posted: November 6, 2017