Back to resultsSirolimus as Primary Therapy for the Treatment of Chronic Graft Versus Host Disease
Primary Purpose
Graft vs Host Disease, Blood and Marrow Transplant (BMT)
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
high dose chemotherapy and autologous hematopoietic cell transplant
Sponsored by
About this trial
This is an interventional treatment trial for Graft vs Host Disease
Eligibility Criteria
Inclusion Criteria:- active chronic GvHD ANC > 1000/mm^3 therapeutic cyclosporine Exclusion Criteria:- uncontrolled systemic infection elevated serum creatinine
Sites / Locations
- Stanford University School of Medicine
Outcomes
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00186667
Brief Title
Sirolimus as Primary Therapy for the Treatment of Chronic Graft Versus Host Disease
Official Title
An Open Label Study of Sirolimus as Primary Therapy for the Treatment of Chronic GVHD Following Allogeneic Bone Marrow Transplant
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 1999 (undefined)
Primary Completion Date
January 2000 (Actual)
Study Completion Date
September 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
Detailed Description
An Open Label Study of Sirolimus as Primary Therapy for the Treatment of Chronic GVHD Following Allogeneic Bone Marrow Transplant
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft vs Host Disease, Blood and Marrow Transplant (BMT)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
high dose chemotherapy and autologous hematopoietic cell transplant
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:- active chronic GvHD
ANC > 1000/mm^3
therapeutic cyclosporine Exclusion Criteria:- uncontrolled systemic infection
elevated serum creatinine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Johnston
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Sirolimus as Primary Therapy for the Treatment of Chronic Graft Versus Host Disease
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