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

Stanford University30 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Graft vs Host Disease Blood and Marrow Transplant (BMT)

Interventions

high dose chemotherapy and autologous hematopoietic cell transplantPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria:- active chronic GvHD * ANC \> 1000/mm\^3 * therapeutic cyclosporine Exclusion Criteria:- uncontrolled systemic infection * elevated serum creatinine

Locations (1)

Stanford University School of Medicine

Stanford, California, United States

Outcomes

Primary Outcomes

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 Outcomes

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.

Data from ClinicalTrials.gov

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