Sirolimus as Primary Therapy for the Treatment of Chronic Graft Versus Host Disease - Full Text View

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
Graft vs Host Disease	Procedure: high dose chemotherapy and autologous hematopoietic cell transplant

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.

Estimated Enrollment:	30
Study Start Date:	January 1999
Estimated Study Completion Date:	September 2005

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

Study ID Numbers:	BMT81, BMT81, NCT00186667
Study First Received:	September 14, 2005
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00186667
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

ClinicalTrials.gov processed this record on January 15, 2009