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

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00186667
First received: September 14, 2005
Last updated: July 23, 2010
Last verified: July 2010

September 14, 2005
July 23, 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. [ Time Frame: unknown ] [ Designated as safety issue: No ]
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. [ Time Frame: unknown ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00186667
BMT81, BMT81
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