Filgrastim-Mobilized Stem Cells for Transplantation Using Unrelated Donors

Description

The purpose of the study is to: - Establish and evaluate a system for collection of filgrastim-mobilized peripheral blood stem cells from National Marrow Donor Program donors (NMDP) donors - Assess the safety among NMDP donors of filgrastim administration and PBSC leukapheresis - Assess the safety and efficacy of filgrastim-mobilized PBSC in unrelated donor hematopoietic stem cell transplant recipients - Determine the acceptability of stem cell donation by filgrastim stimulated apheresis in normal donors

Study Start Date

February 1997

Estimated Completion Date

January 2022

Interventions

  • Drug: Filgrastim

Specialties

  • Internal Medicine: Hematology/Oncology
  • Oncology: BMT/SCT
  • Pathology: Hematopathology
  • Physician Assistant: Hematology/Oncology

MeSH Terms

  • Filgrastim
  • Stem Cells for Transplantation

Study ID

Center for International Blood and Marrow Transplant Research -- PBSC

Status

Recruiting

Trial ID

NCT00785525

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

35000

Sponsor

Center for International Blood and Marrow Transplant Research

Inclusion Criteria

  • PBSC donors must meet the same criteria as NMDP marrow donors. These criteria are set forth in NMDP Standards and the Donor Center Manual of Operations.

Exclusion Criteria

  • Pregnancy or uninterruptible breastfeeding. Pregnancy is an absolute contraindication under this protocol. Women who are breastfeeding must be willing and able to interrupt breastfeeding during the administration of filgrastim and for two days following the final dose.
  • Sensitivity to filgrastim or to E. coli-derived recombinant protein products.
  • History of autoimmune disorders, including rheumatic diseases 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.
  • History of iritis or episcleritis.
  • Thrombocytopenia < 150 x 10(9)/L (< 150,000/µL) at baseline evaluation.
  • Current treatment with lithium. Drug interactions between filgrastim and lithium, which may potentiate the release of neutrophils, have not been fully evaluated.
  • Positive Hemoglobin-Solubility (e.g., SickleDexâ¿¢ or equivalent) test.
  • Donors receiving experimental therapy or investigational agents.

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (82)

Study Location Distance Name Phone Email
NMDP Northeast District New England Office - West Hartford, Connecticut 44.6 miles None None None
The HLA Registry - Oradell, New Jersey 44.8 miles None None None
DKMS Americas - New York, New York 50.2 miles None None None
New York Blood Center - Brooklyn, New York 53.1 miles None None None
New York Blood Center - Brooklyn, New York 53.1 miles None None None
Rhode Island Blood Center - Providence, Rhode Island 103.1 miles None None None
Rhode Island Blood Center - Providence, Rhode Island 103.1 miles None None None
The Caitlin Raymond International Registry - Worcester, Massachusetts 106.5 miles None None None
The Caitlin Raymond International Registry - Worcester, Massachusetts 106.5 miles None None None
NMDP Northeast District - Philadelphia, Pennsylvania 132.3 miles None None None
NMDP Northeast District - Philadelphia, Pennsylvania 132.3 miles None None None
Dana FarberPartners Cancer Care - Boston, Massachusetts 135.8 miles None None None
Dana FarberPartners Cancer Care - Boston, Massachusetts 135.8 miles None None None
CW Bill Young Marrow Donor Center - Rockville, Maryland 253.9 miles None None None
CW Bill Young Marrow Donor Center - Rockville, Maryland 253.9 miles None None None
NIH Marrow Donor Center - Rockville, Maryland 254.7 miles None None None
NMDP Southeast District Washington DC Office - Washington D.C., District of Columbia 257.0 miles None None None
NMDP Northeast District Greater NY State Office - Rochester, New York 259.8 miles None None None
NMDP Northeast District Greater NY State Office - Rochester, New York 259.8 miles None None None
NMDP Southeast District Virginia Office - Richmond, Virginia 340.3 miles None None None
NMDP Southeast District Virginia Office - Richmond, Virginia 340.3 miles None None None
Central Blood Bank - Pittsburgh, Pennsylvania 360.4 miles None None None
Central Blood Bank - Pittsburgh, Pennsylvania 360.4 miles None None None
NMDP Northcentral District - Cleveland, Ohio 437.5 miles None None None
NMDP Southeast District - Charlotte, North Carolina 579.2 miles None None None
NMDP Southeast District - Charlotte, North Carolina 579.2 miles None None None
Community Blood Center - Dayton, Ohio 584.5 miles None None None
NMDP Northcentral District Michigan Office - East Lansing, Michigan 587.0 miles None None None
Cooperative Appalachian Marrow Program - Johnson City, Tennessee 598.4 miles None None None
Michigan Community Blood Centers - Grand Rapids, Michigan 648.4 miles None None None
Michigan Community Blood Centers - Grand Rapids, Michigan 648.4 miles None None None
Indiana Blood Center - Indianapolis, Indiana 686.5 miles None None None
Indiana Blood Center - Indianapolis, Indiana 686.5 miles None None None
James Graham Brown Cancer Center - Louisville, Kentucky 696.1 miles None None None
James Graham Brown Cancer Center - Louisville, Kentucky 696.1 miles None None None
LifeSource - Glenview, Illinois 755.5 miles None None None
The Blood Center of Wisconsin - Milwaukee, Wisconsin 763.7 miles None None None
Blood Assurance Inc - Chattanooga, Tennessee 782.3 miles None None None
Community Blood Services of Illinois - Urbana, Illinois 788.1 miles None None None
Community Blood Center Inc - Appleton, Wisconsin 799.7 miles None None None
Community Blood Center Inc - Appleton, Wisconsin 799.7 miles None None None
Rock River Valley Blood Center - Rockford, Illinois 817.4 miles None None None
Iowa Marrow Donor Program - Iowa City, Iowa 948.5 miles None None None
LifeSouth Community Blood Centers - Gainesville, Florida 952.8 miles None None None
LifeSouth Community Blood Centers - Gainesville, Florida 952.8 miles None None None
Floridas Blood Centers Inc - Orlando, Florida 995.8 miles None None None
Floridas Blood Centers Inc - Orlando, Florida 995.8 miles None None None
NMDP Northcentral District Minnesota Office - Minneapolis, Minnesota 1,041.6 miles None None None
NMDP Northcentral District Minnesota Office - Minneapolis, Minnesota 1,041.6 miles None None None
Florida Blood Services Inc - St. Petersburg, Florida 1,066.9 miles None None None
Gift of Life Bone Marrow Foundation - Boca Raton, Florida 1,099.6 miles None None None
Community Blood Centers of So Florida Inc - Lauderhill, Florida 1,117.7 miles None None None
Mississippi Marrow Donor Program - Jackson, Mississippi 1,118.9 miles None None None
Mississippi Marrow Donor Program - Jackson, Mississippi 1,118.9 miles None None None
NMDP Southcentral District Heart of America Donor Center - Leawood, Kansas 1,140.8 miles None None None
NMDP Southcentral District Heart of America Donor Center - Leawood, Kansas 1,140.8 miles None None None
Sylvan N Goldman Center Oklahoma Blood Institute - Oklahoma City, Oklahoma 1,371.2 miles None None None
Sylvan N Goldman Center Oklahoma Blood Institute - Oklahoma City, Oklahoma 1,371.2 miles None None None
Baylor University Medical Center - Dallas, Texas 1,420.1 miles None None None
Baylor University Medical Center - Dallas, Texas 1,420.1 miles None None None
Carter BloodCare - Bedford, Texas 1,436.4 miles None None None
Carter BloodCare - Bedford, Texas 1,436.4 miles None None None
Cook Childrens Medical Center - Fort Worth, Texas 1,449.7 miles None None None
Gulf Coast Regional Blood Center - Houston, Texas 1,476.6 miles None None None
Scott White Clinic - Temple, Texas 1,513.0 miles None None None
South Texas Blood and Tissue Center - San Antonio, Texas 1,635.2 miles None None None
Colorado Marrow Donor Program - Denver, Colorado 1,662.2 miles None None None
Inland Northwest Blood Center - Spokane, Washington 2,199.2 miles None None None
Puget Sound Blood Center - Seattle, Washington 2,426.6 miles None None None
Puget Sound Blood Center - Seattle, Washington 2,426.6 miles None None None
Blood Bank of San Bernardino Riverside Cts - San Bernadino, California 2,437.9 miles None None None
Blood Bank of San Bernardino Riverside Cts - San Bernadino, California 2,437.9 miles None None None
NMDP Northern California Northwest District Oregon Office - Portland, Oregon 2,468.8 miles None None None
NMDP Northern California Northwest District Oregon Office - Portland, Oregon 2,468.8 miles None None None
City of Hope National Medical Center - Duarte, California 2,472.0 miles None None None
City of Hope National Medical Center - Duarte, California 2,472.0 miles None None None
San Diego Blood Bank - San Diego, California 2,472.6 miles None None None
San Diego Blood Bank - San Diego, California 2,472.6 miles None None None
NMDP Southern California Southwest District - Santa Ana, California 2,474.3 miles None None None
NMDP at Northern California Northwest District - Oakland, California 2,595.5 miles None None None
Hawaii Bone Marrow Donor Registry - Honolulu, Hawaii 5,002.1 miles None None None
Hawaii Bone Marrow Donor Registry - Honolulu, Hawaii 5,002.1 miles None None None

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