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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00511537
Other study ID # UC-9907-CC99251
Secondary ID
Status Completed
Phase N/A
First received August 2, 2007
Last updated August 1, 2013
Start date January 1999
Est. completion date June 2009

Study information

Verified date August 2013
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

This study performs HLA matched stem cell transplantation from unrelated donors in adults who require stem cell transplantation but do not have a matched related donor available. The incidence of graft-versus-host disease in unrelated stem cell transplantation is recorded. This study also monitors the activity and toxicity of total body irradiation and cyclosphosphamide followed by stem cell transplantation from matched unrelated donors.


Description:

This protocol identifies a standard-of-care method for unrelated stem cell transplantation in adults. Performing this service in a consistent and documented fashion allows investigators to obtain informed consent from recipients. Data is tabulated locally for quality-control comparisons with nationally-reported standards. As a condition of maintaining transplant center status and to have acess to NMDP-registered donors, UCSF submits clinical and outcome data to the NMDP. As a result, UCSF is contributing to the resolution of remaining uncertainties regarding particular transplantation practices.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 54 Years
Eligibility Inclusion Criteria:

- Age >15 and <55

- Adequate renal function with serum creatinine <2.0 mg/dl

- Pulmonary diffusing capacity>50% of predicted

- Cardiac ejection fraction >40% as measured by radionuclide wall motion study or echocardiography

- Total bilirubin must be <2.5 mg/dl.

- Alkaline phosphatase and AST must be less than three times the upper limit of normal

- Negative serology for the human immunodeficiency virus

- Available HLA-matched donor

- Signed informed consent

Exclusion Criteria:

- No fully or single-antigen-mismatched sibling donor is available to donate stem cells

- No active liver disease.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Locations

Country Name City State
United States University of California San Francisco San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

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