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Sirolimus as Primary Therapy for the Treatment of Chronic Graft Versus Host Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00186667
First Posted: September 16, 2005
Last Update Posted: July 27, 2010
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:
Stanford University
September 14, 2005
September 16, 2005
July 27, 2010
January 1999
January 2000   (Final data collection date for primary outcome measure)
Evaluate the efficacy of clinical activity of sirolimus in combination with cyclosporine and corticosteroids as first line therapy for the treatment of chronic Graft Versus Host Disease.
Efficacy
Complete list of historical versions of study NCT00186667 on ClinicalTrials.gov Archive Site
Evaluate the safety of clinical activity of sirolimus in combination with cyclosporine and corticosteroids as first line therapy for the treatment of chronic Graft Versus Host Disease.
safety
Not Provided
Not Provided
 
Sirolimus as Primary Therapy for the Treatment of Chronic Graft Versus Host Disease
An Open Label Study of Sirolimus as Primary Therapy for the Treatment of Chronic GVHD Following Allogeneic Bone Marrow Transplant
Evaluate the clinical activity of sirolimus in combination with cyclosporine and corticosteroids as first line therapy for the treatment of chronic Graft Versus Host Disease.
An Open Label Study of Sirolimus as Primary Therapy for the Treatment of Chronic GVHD Following Allogeneic Bone Marrow Transplant
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Graft vs Host Disease
  • Blood and Marrow Transplant (BMT)
Procedure: high dose chemotherapy and autologous hematopoietic cell transplant
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
September 2005
January 2000   (Final data collection date for primary outcome measure)

Inclusion Criteria:- active chronic GvHD

  • ANC > 1000/mm^3
  • therapeutic cyclosporine

Exclusion Criteria:- uncontrolled systemic infection

- elevated serum creatinine

Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00186667
BMT81
BMT81
Not Provided
Not Provided
Not Provided
Laura Johnston, Stanford University School of Medicine
Stanford University
Not Provided
Principal Investigator: Laura Johnston Stanford University
Stanford University
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP