Unrelated Stem Cell Transplantation for Adults With Hematopoietic Disorders

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00511537

Enrollment

Registered

2007-08-06

Start date

1999-01-31

Completion date

2009-06-30

Last updated

2013-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ALL, AML, CML, Lymphoma, Myelodysplasia, Myeloproliferative Disorders

Keywords

AML, ALL, CML, Lymphoma, Myelodysplasia, Unrelated stem cell transplantation, Hematopoietic disorders

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to 54 Years

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.

Countries

United States

Outcome results