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

This study has been completed.

First Received: September 14, 2005 Last Updated: March 20, 2009 History of Changes

Sponsored by:	Stanford University
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00186667

Purpose

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.

Condition	Intervention	Phase
Graft vs Host Disease	Procedure: high dose chemotherapy and autologous hematopoietic cell transplant	Phase II

Drug Information available for: Sirolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open Label Study of Sirolimus as Primary Therapy for the Treatment of Chronic GVHD Following Allogeneic Bone Marrow Transplant

Further study details as provided by Stanford University:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.

Enrollment:	30
Study Start Date:	January 1999
Study Completion Date:	September 2005
Primary Completion Date:	January 2000 (Final data collection date for primary outcome measure)

Detailed Description:

An Open Label Study of Sirolimus as Primary Therapy for the Treatment of Chronic GVHD Following Allogeneic Bone Marrow Transplant

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:- active chronic GvHD

ANC > 1000/mm^3
therapeutic cyclosporine

Exclusion Criteria:- uncontrolled systemic infection

elevated serum creatinine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00186667

Locations

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator:

Laura Johnston

Stanford University

More Information

No publications provided

Responsible Party:	Stanford University School of Medicine ( BMT Referrals )
Study ID Numbers:	BMT81, BMT81, NCT00186667
Study First Received:	September 14, 2005
Last Updated:	March 20, 2009
ClinicalTrials.gov Identifier:	NCT00186667 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Sirolimus
Graft Versus Host Disease
Graft vs Host Disease
Homologous Wasting Disease

Additional relevant MeSH terms:

Immune System Diseases
Graft vs Host Disease

ClinicalTrials.gov processed this record on May 07, 2009