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Sirolimus as Treatment of Steroid-Refractory or Steroid-Dependent Chronic Graft-Versus-Host Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00388362
First Posted: October 16, 2006
Last Update Posted: April 21, 2017
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.
Information provided by (Responsible Party):
Laura Johnston, Stanford University
Results First Submitted: December 7, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Graft vs Host Disease
Interventions: Drug: Sirolimus
Drug: Prednisone

  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
Sirolimus Therapy Administration of Sirolimus and Prednisone

Participant Flow for 2 periods

Period 1:   Enrolled
    Sirolimus Therapy
STARTED   36 
COMPLETED   23 
NOT COMPLETED   13 
Ineligible                1 
Adverse Event                9 
Death                1 
Loss insurance                1 
Withdrawal by Subject                1 

Period 2:   Remained on Study Median of 514 Days
    Sirolimus Therapy
STARTED   23 
COMPLETED   21 
NOT COMPLETED   2 
Death                2 



  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.
Administration of Sirolimus and Prednisone

Reporting Groups
  Description
Sirolimus Administration of Sirolimus and Prednisone

Baseline Measures
   Sirolimus 
Overall Participants Analyzed 
[Units: Participants]
 36 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      33  91.7% 
>=65 years      3   8.3% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      17  47.2% 
Male      19  52.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      4  11.1% 
Not Hispanic or Latino      28  77.8% 
Unknown or Not Reported      4  11.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      3   8.3% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      1   2.8% 
White      27  75.0% 
More than one race      0   0.0% 
Unknown or Not Reported      5  13.9% 


  Outcome Measures
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1.  Primary:   Clinical Activity   [ Time Frame: 3 month intervals after the initiation of sirolimus until 2 years after the initiation of sirolimus ]

2.  Secondary:   Overall Survival   [ Time Frame: 3 month intervals after the initiation of sirolimus until 2 years after the initiation of sirolimus ]


  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: Laura Johnston, MD
Organization: Stanford University
phone: 650-723-0822
e-mail: janices1@stanford.edu



Responsible Party: Laura Johnston, Stanford University
ClinicalTrials.gov Identifier: NCT00388362     History of Changes
Other Study ID Numbers: IRB-3587
96589 ( Other Identifier: Stanford University Alternate IRB Approval Number )
BMT175 ( Other Identifier: OnCore Number )
First Submitted: October 12, 2006
First Posted: October 16, 2006
Results First Submitted: December 7, 2016
Results First Posted: April 21, 2017
Last Update Posted: April 21, 2017