Unrelated Stem Cell Transplantation for Adults With Hematopoietic Disorders

Lymphoma Clinical Trial

Official title:

Standard of Care Trial: Unrelated Stem Cell Transplantation for Adults With Hematopoietic Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00511537
• Other study ID #: UC-9907-CC99251
• 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

Related Conditions & MeSH terms

• ALL
• AML
• CML
• Lymphoma
• Myelodysplasia
• Myelodysplastic Syndromes
• Myeloproliferative Disorders
• Preleukemia

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,