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

Phase 2

Completed

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

• Registration Number: NCT00186667
• Lead Sponsor: Stanford University

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 1999-01
• Primary Completion: 2000-01
• Study Completion: 2005-09
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-16
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-07
• Last Update Posted: 2020-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• active chronic GvHD

• ANC > 1000/mm^3
• therapeutic cyclosporine

Exclusion Criteria

• uncontrolled systemic infection

• elevated serum creatinine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States