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Unrelated Stem Cell Transplantation for Adults With Hematopoietic Disorders

University of California San Francisco (UCSF) logo

University of California San Francisco (UCSF)

Status

Completed

Conditions

AML
CML
Myeloproliferative Disorders
Myelodysplasia
ALL
Lymphoma

Study type

Observational

Funder types

Other

Identifiers

NCT00511537
UC-9907-CC99251

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

16 to 54 years old

Volunteers

No 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

Exclusion criteria

  • No fully or single-antigen-mismatched sibling donor is available to donate stem cells
  • No active liver disease.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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