Filgrastim-Mobilized Stem Cells for Transplantation Using Unrelated Donors

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 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: July 3, 2014
Last verified: July 2014

November 3, 2008
July 3, 2014
February 1997
January 2017   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00785525 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Filgrastim-Mobilized Stem Cells for Transplantation Using Unrelated Donors
Filgrastim-Mobilized Peripheral Blood Stem Cells for Allogeneic Transplantation With Unrelated Donors

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

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.

Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: Open Label
Healthy
Drug: Filgrastim
PBSC donors will receive 10 µg/kg of filgrastim subcutaneously each day of a five day mobilization schedule.
Other Name: Neupogen®, GCSF
Not Provided
Pulsipher MA, Chitphakdithai P, Logan BR, Leitman SF, Anderlini P, Klein JP, Horowitz MM, Miller JP, King RJ, Confer DL. Donor, recipient, and transplant characteristics as risk factors after unrelated donor PBSC transplantation: beneficial effects of higher CD34+ cell dose. Blood. 2009 Sep 24;114(13):2606-16. Epub 2009 Jul 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20000
January 2022
January 2017   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
Yes
Contact: Drema Carter 612-884-8438 dcarter@nmdp.org
United States,   Puerto Rico
 
NCT00785525
PBSC
Yes
Center for International Blood and Marrow Transplant Research
Center for International Blood and Marrow Transplant Research
National Marrow Donor Program
Principal Investigator: John P Miller, MD, PhD National Marrow Donor Program
Center for International Blood and Marrow Transplant Research
July 2014

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