Unrelated Stem Cell Transplantation for Adults With Hematopoietic Disorders

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT00511537

Collaborator

(none)

Enrollment

Location

125

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
CML ALL AML Myelodysplasia Lymphoma Myeloproliferative Disorders

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 Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jan 1, 1999

Actual Primary Completion Date :

Jun 1, 2009

Actual Study Completion Date :

Jun 1, 2009

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 54 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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