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Filgrastim-Mobilized Stem Cells for Transplantation Using Unrelated Donors

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ClinicalTrials.gov Identifier: NCT00785525
Recruitment Status : Recruiting
First Posted : November 5, 2008
Last Update Posted : June 19, 2019
Sponsor:
Collaborator:
National Marrow Donor Program
Information provided by (Responsible Party):
Center for International Blood and Marrow Transplant Research

Study Description
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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

Condition or disease Intervention/treatment Phase
Healthy Drug: Filgrastim Phase 3

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Filgrastim-Mobilized Peripheral Blood Stem Cells for Allogeneic Transplantation With Unrelated Donors
Actual Study Start Date : February 1997
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

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Arms and Interventions
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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

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

Secondary Outcome Measures :
  1. Assess the safety among NMDP donors of filgrastim administration and PBSC leukapheresis [ Time Frame: Ongoing ]
  2. Assess the safety and efficacy of filgrastim-mobilized PBSC in unrelated donor hematopoietic stem cell transplant recipients [ Time Frame: Ongoing ]
  3. Determine the acceptability of stem cell donation by filgrastim stimulated apheresis in normal donors [ Time Frame: Ongoing ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00785525


Contacts
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Contact: Christine Jacox 612-627-8130 christine.jacox@nmdp.org

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Sponsors and Collaborators
Center for International Blood and Marrow Transplant Research
National Marrow Donor Program
Investigators
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Principal Investigator: John P Miller, MD, PhD National Marrow Donor Program
More Information
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Additional Information:
Donors from this study are drawn from members on the Be The Match Registry who are a possible match for a patient who needs a transplant. If you are interested in becoming a member click on the link and read more about our program.  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier: NCT00785525     History of Changes
Other Study ID Numbers: PBSC
First Posted: November 5, 2008    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Keywords provided by Center for International Blood and Marrow Transplant Research:
Healthy Unrelated Stem Cell Donors
Additional relevant MeSH terms:
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Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs