Unrelated Stem Cell Transplantation for Adults With Hematopoietic Disorders

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00511537
First received: August 2, 2007
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

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
CML
ALL
AML
Myelodysplasia
Lymphoma
Myeloproliferative Disorders

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Standard of Care Trial: Unrelated Stem Cell Transplantation for Adults With Hematopoietic Disorders

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Estimated Enrollment: 30
Study Start Date: January 1999
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   16 Years to 54 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Hematopoeietic Disorders

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00511537

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

Additional Information:
No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00511537     History of Changes
Other Study ID Numbers: UC-9907-CC99251
Study First Received: August 2, 2007
Last Updated: August 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
AML
ALL
CML
Lymphoma
Myelodysplasia
Unrelated stem cell transplantation
Hematopoietic disorders

Additional relevant MeSH terms:
Lymphoma
Myelodysplastic Syndromes
Preleukemia
Myeloproliferative Disorders
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions

ClinicalTrials.gov processed this record on August 01, 2014