Unrelated Stem Cell Transplantation for Adults With Hematopoietic Disorders

Completed

• Conditions: CML; ALL; AML; Myelodysplasia; Lymphoma; Myeloproliferative Disorders

• Registration Number: NCT00511537
• Lead Sponsor: University of California, San Francisco

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 1999-01
• Study First Submitted: 2007-08-02
• Study First Submitted QC: 2007-08-02
• Study First Posted: 2007-08-06
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-01
• Last Update Posted: 2013-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States