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OpenTrials
Completed

NCT Number: NCT00186667

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

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.

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Key information

Conditions

Graft vs Host Disease Blood and Marrow Transplant (BMT) Immune System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

- active chronic GvHD

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

Treatment and study plan

high dose chemotherapy and autologous hematopoietic cell transplant

Procedure

Primary outcomes

  1. 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

  1. 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
1999
Primary completion
2000
Study completion
2005
First posted
Sep 16, 2005
Registry last updated
Apr 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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