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

Graft vs Host Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00186667
• Other study ID #: IRB-SQL 75568
• Secondary ID: BMT81
• Status: Completed
• Phase: Phase 2
• Start date: January 1999
• Est. completion date: September 2005

Study information

• Verified date: April 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2005
• Est. primary completion date: January 2000
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:- active chronic GvHD

• ANC > 1000/mm^3

• therapeutic cyclosporine Exclusion Criteria:- uncontrolled systemic infection

• elevated serum creatinine

Related Conditions & MeSH terms

• Blood and Marrow Transplant (BMT)
• Graft vs Host Disease

Intervention

Procedure:
• high dose chemotherapy and autologous hematopoietic cell transplant

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.