Expired Study
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Stanford, California 94305


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.


Study summary:

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


Criteria:

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


Study is Available At:


Original ID:

BMT81


NCT ID:

NCT00186667


Secondary ID:

BMT81


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

70 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Stanford University


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

30


Enrollment Type:

Actual


Overall Contact Information

Official Name:Laura Johnston
Principal Investigator
Stanford University

Study Dates

Start Date:January 1999
Completion Date:September 2005
Completion Type:Actual
Primary Completion Date:January 2000
Primary Completion Type:Actual
Verification Date:July 2010
Last Changed Date:July 23, 2010
First Received Date:September 14, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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
Safety Issues:True
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Procedure
Name:high dose chemotherapy and autologous hematopoieti

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Stanford University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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