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Filgrastim-Mobilized Peripheral Blood Stem Cells for Allogeneic Transplantation With Unrelated Donors

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00511550
First received: August 3, 2007
Last updated: March 3, 2008
Last verified: July 2007
History of Changes

August 3, 2007
March 3, 2008
August 2005
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Complete list of historical versions of study NCT00511550 on ClinicalTrials.gov Archive Site
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Filgrastim-Mobilized Peripheral Blood Stem Cells for Allogeneic Transplantation With Unrelated Donors
Filgrastim-Mobilized Peripheral Blood Stem Cells for Allogeneic Transplantation With Unrelated Donors

Peripheral blood stem cells (PBSCs) collected following stimulation with filgrastim are commonly used for autologous hematopoietic transplants. PBSCs are also now being used for some syngeneic and allogeneic hematopoietic transplants involving HLA-matched sibling donors. However, many issues remain unanswered about the use of PBSCs for allogeneic transplants and the effects of filgrastim on healthy individuals. The purpose of this study is to determine the effectiveness of filgrastim stimulated PBSCs in hematopoietic cell transplants involving unrelated donors and to determine the effects of this donation process on unrelated stem cell donors.

This study establishes and evaluates a system to supply peripheral blood stem cell (PBSC)products for use in unrelated donor hematopoietic stem cell (HSC) transplantation. The protocol describes processes for donor identification, education and evaluation. Procedures for administration and monitoring of the stem cell mobilizing agent filgrastim are included. The study also describes procedures for the collection of PBSC products by leukapheresis and includes provisions for indefinite donor follow-up.
Observational
Time Perspective: Prospective
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Healthy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
November 2007
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Inclusion Criteria:

-Healthy adults

Exclusion Criteria:

  • Pregnancy or uninterruptible breastfeeding.
  • Sensitivity to filgrastim or to E. coli-derived recombinant protein products.
  • History of autoimmune disorders, including rheumatic disease and thyroid disorders. Exception: As with bone marrow donations, donors with a history of thyroid disease who have undergone successful therapy may be suitable.
  • History of deep vein thrombosis or pulmonary embolism.
  • Thrombocytopenia <150 x 10(9)/L (<150,000/uL) at baseline evaluation.
  • Current treatment with lithium. Drug interactions between filgrastim and lithium, which may potentiate the release of neutrophils, have not been full evaluated.
  • Positive Hemoglobin-Solubility (e.g. SickleDex or equivalent) test.
  • Donors receiving experimental therapy or investigational agents.
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00511550
UC-2508
Yes
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University of California, San Francisco
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Principal Investigator: Thomas G. Martin, M.D. University of California, San Francisco
Study Director: John Miller, M.D.,Ph.D. National Marrow Donor Program
University of California, San Francisco
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP