Filgrastim-Mobilized Stem Cells for Transplantation Using Unrelated Donors

This study is currently recruiting participants.
Verified January 2014 by Center for International Blood and Marrow Transplant Research
Sponsor:
Collaborator:
National Marrow Donor Program
Information provided by (Responsible Party):
Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier:
NCT00785525
First received: November 3, 2008
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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

Condition Intervention Phase
Healthy
Drug: Filgrastim
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Filgrastim-Mobilized Peripheral Blood Stem Cells for Allogeneic Transplantation With Unrelated Donors

Resource links provided by NLM:


Further study details as provided by Center for International Blood and Marrow Transplant Research:

Primary Outcome Measures:
  • Establish and evaluate a system for collection of filgrastim-mobilized peripheral blood stem cells from NMDP donors. [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assess the safety among NMDP donors of filgrastim administration and PBSC leukapheresis [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ]
  • Assess the safety and efficacy of filgrastim-mobilized PBSC in unrelated donor hematopoietic stem cell transplant recipients [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ]
  • Determine the acceptability of stem cell donation by filgrastim stimulated apheresis in normal donors [ Time Frame: Ongoing ] [ Designated as safety issue: No ]

Estimated Enrollment: 20000
Study Start Date: February 1997
Estimated Study Completion Date: January 2022
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Filgrastim
    PBSC donors will receive 10 µg/kg of filgrastim subcutaneously each day of a five day mobilization schedule.
    Other Name: Neupogen®, GCSF
Detailed Description:

For many years, allogeneic bone marrow transplantation has been used to successfully treat leukemias, other hematologic conditions and congenital disorders. The first unrelated donor transplants were performed in the late 1970s, but this procedure did not become widely available until the development of several consolidated unrelated donor registries around the world. The National Marrow Donor Program, established in 1987, is the world's largest registry and currently lists more than 7 million donors. Since its beginning, NMDP has facilitated more than 30,000 unrelated transplants.

Although not a licensed indication, considerable experience has been accumulated concerning administration of filgrastim to normal adults. Most of these adults were volunteer research subjects or donors of PBSC for use in related donor transplants. Beginning in February 1997, filgrastim stimulated PBSC have been collected from NMDP donors under protocol. The protocol (locally referred to as G2) began under an NMDP-sponsored Investigational New Drug (IND) application filed with FDA for collecting PBSC for a second donation following an initial donation of bone marrow. In 1999 a second protocol was opened (locally referred to as G1) as requests for PBSC as a primary donation source became more common. In 2005 the two protocols were combined to eliminate redundancy and provide for ease of use.

The protocol 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 protocol also describes procedures for the collection of PBSC products by leukapheresis and includes provisions for long term donor follow-up.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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., SickleDex™ or equivalent) test.
  • Donors receiving experimental therapy or investigational agents.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00785525

Contacts
Contact: Nicholas Halbert 612-884-8722 nhalbert@nmdp.org

  Hide Study Locations
Locations
United States, California
City of Hope National Medical Center Recruiting
Duarte, California, United States, 91010
NMDP at Northern California & Northwest District Recruiting
Oakland, California, United States, 94612
Blood Bank of San Bernardino & Riverside Cts. Recruiting
San Bernadino, California, United States, 92408
San Diego Blood Bank Recruiting
San Diego, California, United States, 92103
NMDP Southern California & Southwest District Recruiting
Santa Ana, California, United States, 92705
United States, Colorado
Colorado Marrow Donor Program Recruiting
Denver, Colorado, United States, 80230
United States, Connecticut
NMDP Northeast District - New England Office Recruiting
West Hartford, Connecticut, United States, 06110
United States, District of Columbia
NMDP Southeast District - Washington D.C. Office Recruiting
Washington D.C., District of Columbia, United States, 20004
United States, Florida
Gift of Life Bone Marrow Foundation Recruiting
Boca Raton, Florida, United States, 33431
LifeSouth Community Blood Centers Recruiting
Gainesville, Florida, United States, 32607
Community Blood Centers of So. Florida, Inc. Recruiting
Lauderhill, Florida, United States, 33313
Florida's Blood Centers, Inc. Recruiting
Orlando, Florida, United States, 32809
Florida Blood Services, Inc. Recruiting
St. Petersburg, Florida, United States, 33716
United States, Hawaii
Hawaii Bone Marrow Donor Registry Recruiting
Honolulu, Hawaii, United States, 96817
United States, Illinois
LifeSource Recruiting
Glenview, Illinois, United States, 60025
Rock River Valley Blood Center Recruiting
Rockford, Illinois, United States, 61107
Community Blood Services of Illinois Recruiting
Urbana, Illinois, United States, 61801
United States, Indiana
Indiana Blood Center Recruiting
Indianapolis, Indiana, United States, 46208
United States, Iowa
Iowa Marrow Donor Program Recruiting
Iowa City, Iowa, United States, 52242
United States, Kansas
NMDP Southcentral District, Heart of America Donor Center Recruiting
Leawood, Kansas, United States, 66206
United States, Kentucky
James Graham Brown Cancer Center Recruiting
Louisville, Kentucky, United States, 40202
United States, Maryland
NIH Marrow Donor Center Recruiting
Rockville, Maryland, United States, 20892
C.W. Bill Young Marrow Donor Center Recruiting
Rockville, Maryland, United States, 20852
United States, Massachusetts
Dana Farber/Partners Cancer Care Recruiting
Boston, Massachusetts, United States, 02115
The Caitlin Raymond International Registry Recruiting
Worcester, Massachusetts, United States, 01655
United States, Michigan
NMDP Northcentral District - Michigan Office Recruiting
East Lansing, Michigan, United States, 48823
Michigan Community Blood Centers Recruiting
Grand Rapids, Michigan, United States, 49501
United States, Minnesota
NMDP Northcentral District - Minnesota Office Recruiting
Minneapolis, Minnesota, United States, 55413
United States, Mississippi
Mississippi Marrow Donor Program Recruiting
Jackson, Mississippi, United States, 39216
United States, New Jersey
The HLA Registry Recruiting
Oradell, New Jersey, United States, 07649
United States, New York
New York Blood Center Recruiting
Brooklyn, New York, United States, 11201
DKMS Americas Recruiting
New York, New York, United States, 10016
NMDP Northeast District - Greater NY State Office Recruiting
Rochester, New York, United States, 14607
United States, North Carolina
NMDP Southeast District Recruiting
Charlotte, North Carolina, United States, 28269
United States, Ohio
NMDP Northcentral District Recruiting
Cleveland, Ohio, United States, 44131
Community Blood Center Recruiting
Dayton, Ohio, United States, 45402
United States, Oklahoma
Sylvan N. Goldman Center, Oklahoma Blood Institute Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
NMDP Northern California & Northwest District - Oregon Office Recruiting
Portland, Oregon, United States, 97210
United States, Pennsylvania
NMDP Northeast District Recruiting
Philadelphia, Pennsylvania, United States, 19123
Central Blood Bank Recruiting
Pittsburgh, Pennsylvania, United States, 15220
United States, Rhode Island
Rhode Island Blood Center Recruiting
Providence, Rhode Island, United States, 02908
United States, Tennessee
Blood Assurance, Inc. Recruiting
Chattanooga, Tennessee, United States, 37403
Cooperative Appalachian Marrow Program Recruiting
Johnson City, Tennessee, United States, 37604
United States, Texas
Carter BloodCare Recruiting
Bedford, Texas, United States, 76021
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75246
Cook Children's Medical Center Recruiting
Fort Worth, Texas, United States, 76104
Gulf Coast Regional Blood Center Recruiting
Houston, Texas, United States, 77054
South Texas Blood and Tissue Center Recruiting
San Antonio, Texas, United States, 78201
Scott & White Clinic Recruiting
Temple, Texas, United States, 76508
United States, Virginia
NMDP Southeast District - Virginia Office Recruiting
Richmond, Virginia, United States, 23229
United States, Washington
Puget Sound Blood Center Recruiting
Seattle, Washington, United States, 98104
Inland Northwest Blood Center Recruiting
Spokane, Washington, United States, 99201
United States, Wisconsin
Community Blood Center, Inc. Recruiting
Appleton, Wisconsin, United States, 54914
The Blood Center of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53233
Puerto Rico
NMDP at Puerto Rico Recruiting
Guaynabo, Puerto Rico, 00968
Sponsors and Collaborators
Center for International Blood and Marrow Transplant Research
National Marrow Donor Program
Investigators
Principal Investigator: John P Miller, MD, PhD National Marrow Donor Program
  More Information

Additional Information:
No publications provided by Center for International Blood and Marrow Transplant Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier: NCT00785525     History of Changes
Other Study ID Numbers: PBSC
Study First Received: November 3, 2008
Last Updated: January 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Center for International Blood and Marrow Transplant Research:
Healthy Unrelated Stem Cell Donors

Additional relevant MeSH terms:
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014