Unrelated Stem Cell Transplantation for Adults With Hematopoietic Disorders

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-01-31

Study Completion Date

2009-06-30

Brief Summary

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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

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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.

Conditions

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CML ALL AML Myelodysplasia Lymphoma Myeloproliferative Disorders

Keywords

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AML ALL CML Lymphoma Myelodysplasia Unrelated stem cell transplantation Hematopoietic disorders

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

54 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas G. Martin, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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UC-9907-CC99251

Identifier Type: -

Identifier Source: org_study_id