Unrelated Stem Cell Transplantation for Adults With Hematopoietic Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00511537
Recruitment Status : Completed
First Posted : August 6, 2007
Last Update Posted : August 2, 2013
Information provided by (Responsible Party):
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.

Condition or disease
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 Type : Observational
Estimated 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 : January 1999
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

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Ages Eligible for Study:   16 Years to 54 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Hematopoeietic Disorders

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00511537

United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Principal Investigator: Thomas G. Martin, M.D. University of California, San Francisco

Responsible Party: University of California, San Francisco Identifier: NCT00511537     History of Changes
Other Study ID Numbers: UC-9907-CC99251
First Posted: August 6, 2007    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: August 2013

Keywords provided by University of California, San Francisco:
Unrelated stem cell transplantation
Hematopoietic disorders

Additional relevant MeSH terms:
Myeloproliferative Disorders
Myelodysplastic Syndromes
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions