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HealthyPhase 3NCT00785525

Filgrastim-Mobilized Stem Cells for Transplantation Using Unrelated Donors

A Phase 3 study testing Filgrastim in people with Healthy, run by Center for International Blood and Marrow Transplant Research at 4 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Filgrastim
Type of treatment
Injection or infusion
How many people
60,000 participants
Where
4 sitesUnited States
Study dates
Feb 1997to Jan 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lisa Erickson contact

PBSCStudyTeam@nmdp.org

United States4 sites, 4 recruiting

  • Gift of Life Bone Marrow Foundation

    Boca Raton, Florida, 33431

    Recruiting

  • Be The Match

    Minneapolis, Minnesota, 55401

    Recruiting

  • DKMS Americas

    New York, New York, 10016

    Recruiting

  • C.W. Bill Young Marrow Donor Center

    Rockville, Maryland, 20852

    Michael Donnelly, MD

    Recruiting

Other trials in United States

About this study

Official title: 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
Read the 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.

Conditions
Healthy
Being tested
Filgrastim
Keywords
Healthy Unrelated Stem Cell Donors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FilgrastimDrug

    Also called Neupogen®, GCSF

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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Ongoing

Secondary outcomes (3)

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

    Measured: Ongoing

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

    Measured: Ongoing

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

    Measured: Ongoing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2008 (estimated)
  2. Study startFeb 1997
  3. Primary completionJan 2030 (estimated)
  4. Study completionJan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00785525
Sponsor's protocol ID
PBSC
Status last verified
Jan 2025
First submitted
3 Nov 2008
Last updated
13 Apr 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 19608747

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Filgrastim in people with Healthy, run by Center for International Blood and Marrow Transplant Research at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lisa Erickson (PBSCStudyTeam@nmdp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Establish and evaluate a system for collection of filgrastim-mobilized peripheral blood stem cells from NMDP donors. (time frame: Ongoing). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00785525, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.

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