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

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00186667
First received: September 14, 2005
Last updated: July 23, 2010
Last verified: July 2010
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Steroids
U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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. [ Time Frame: unknown ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: unknown ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: January 1999
Study Completion Date: September 2005
Primary Completion Date: January 2000 (Final data collection date for primary outcome measure)
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:- active chronic GvHD

  • ANC > 1000/mm^3
  • therapeutic cyclosporine

Exclusion Criteria:- uncontrolled systemic infection

- elevated serum creatinine

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Laura Johnston, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00186667     History of Changes
Other Study ID Numbers: BMT81, BMT81
Study First Received: September 14, 2005
Last Updated: July 23, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 18, 2013