NCT00785525

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60,000

participants targeted

Target at P75+ for phase_3 healthy

Timeline
45mo left

Started Feb 1997

Longer than P75 for phase_3 healthy

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Feb 1997Jan 2030

Study Start

First participant enrolled

February 1, 1997

Completed
11.8 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 5, 2008

Completed
21.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

April 13, 2025

Status Verified

January 1, 2025

Enrollment Period

32.9 years

First QC Date

November 3, 2008

Last Update Submit

April 9, 2025

Conditions

Healthy

Keywords

Healthy Unrelated Stem Cell Donors

Outcome Measures

Primary Outcomes (1)

  • Establish and evaluate a system for collection of filgrastim-mobilized peripheral blood stem cells from NMDP donors.

    Ongoing

Secondary Outcomes (3)

  • Assess the safety among NMDP donors of filgrastim administration and PBSC leukapheresis

    Ongoing

  • Assess the safety and efficacy of filgrastim-mobilized PBSC in unrelated donor hematopoietic stem cell transplant recipients

    Ongoing

  • Determine the acceptability of stem cell donation by filgrastim stimulated apheresis in normal donors

    Ongoing

Interventions

FilgrastimDRUG

PBSC donors will receive 10 µg/kg of filgrastim subcutaneously each day of a five day mobilization schedule.

Also known as: Neupogen®, GCSF

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • PBSC donors must meet the same criteria as NMDP marrow donors. These criteria are set forth in the Donor Center Manual of Operations.
  • Confirmatory pregnancy test must be performed within 15 days of collection and prior to the start of filgrastim administration; this may require more than one test to be performed.

You may not qualify if:

  • 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/uL) 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.
  • Positive pregnancy test collected/reported prior to start of filgrastim.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Gift of Life Bone Marrow Foundation

Boca Raton, Florida, 33431, United States

RECRUITING

C.W. Bill Young Marrow Donor Center

Rockville, Maryland, 20852, United States

RECRUITING

Be The Match

Minneapolis, Minnesota, 55401, United States

RECRUITING

DKMS Americas

New York, New York, 10016, United States

RECRUITING

Related Publications (1)

  • 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. doi: 10.1182/blood-2009-03-208355. Epub 2009 Jul 16.

    PMID: 19608747DERIVED

Related Links

MeSH Terms

Interventions

Filgrastim

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • John P Miller, MD, PhD

    National Marrow Donor Program

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Erickson

CONTACT

PBSCStudyTeam@nmdp.org

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2008

First Posted

November 5, 2008

Study Start

February 1, 1997

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

April 13, 2025

Record last verified: 2025-01

Locations

US(4)