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

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ClinicalTrials.gov Identifier: NCT00186667
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : July 27, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Graft vs Host Disease Blood and Marrow Transplant (BMT) Procedure: high dose chemotherapy and autologous hematopoietic cell transplant Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study of Sirolimus as Primary Therapy for the Treatment of Chronic GVHD Following Allogeneic Bone Marrow Transplant
Study Start Date : January 1999
Actual Primary Completion Date : January 2000
Actual Study Completion Date : September 2005





Primary Outcome Measures :
  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 Outcome Measures :
  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.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:- active chronic GvHD

  • ANC > 1000/mm^3
  • therapeutic cyclosporine

Exclusion Criteria:- uncontrolled systemic infection

- elevated serum creatinine


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00186667


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Laura Johnston Stanford University

Responsible Party: Laura Johnston, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00186667     History of Changes
Other Study ID Numbers: BMT81
BMT81
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: July 27, 2010
Last Verified: July 2010

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs