Unrelated Stem Cell Transplantation for Adults With Hematopoietic Disorders
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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 |
| 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) |
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 |
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.
Contacts and Locations| United States, California | |
| University of California San Francisco | |
| San Francisco, California, United States, 94143 | |
| 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, University of California |
| ClinicalTrials.gov Identifier: | NCT00511537 History of Changes |
| Other Study ID Numbers: | UC-9907-CC99251 |
| Study First Received: | August 2, 2007 |
| Last Updated: | March 23, 2010 |
| 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 May 22, 2013