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

Stanford University

Status and phase: Completed; Phase 2

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

Treatments: Procedure: high dose chemotherapy and autologous hematopoietic cell transplant

Study type: Interventional

Funder types: Other

Identifiers

NCT00186667

BMT81 (Other Identifier)

IRB-SQL 75568

Details and patient eligibility

About

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.

Full description

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

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:- active chronic GvHD

• ANC > 1000/mm^3
• therapeutic cyclosporine Exclusion Criteria:- uncontrolled systemic infection
• elevated serum creatinine

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)