RECRUITING

Filgrastim-Mobilized Stem Cells for Transplantation Using Unrelated Donors

Conditions

Healthy Healthy Unrelated Stem Cell Donors

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Filgrastim-Mobilized Peripheral Blood Stem Cells for Allogeneic Transplantation With Unrelated Donors

Quick Facts

Study Start:1997-02

Study Completion:2030-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT00785525

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. PBSC donors must meet the same criteria as NMDP marrow donors. These criteria are set forth in the Donor Center Manual of Operations. 2. 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.	1. 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. 2. Sensitivity to filgrastim or to E. coli-derived recombinant protein products. 3. 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. 4. History of deep vein thrombosis or pulmonary embolism. 5. History of iritis or episcleritis. 6. Thrombocytopenia \< 150 x 10\^9/L (\< 150,000/uL) at baseline evaluation. 7. Current treatment with lithium. Drug interactions between filgrastim and lithium, which may potentiate the release of neutrophils, have not been fully evaluated. 8. Positive Hemoglobin-Solubility (e.g., SickleDex or equivalent) test. 9. Donors receiving experimental therapy or investigational agents. 10. Positive pregnancy test collected/reported prior to start of filgrastim.

Inclusion Criteria

Exclusion Criteria

1. PBSC donors must meet the same criteria as NMDP marrow donors. These criteria are set forth in the Donor Center Manual of Operations.
2. 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.

1. 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.
2. Sensitivity to filgrastim or to E. coli-derived recombinant protein products.
3. 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.
4. History of deep vein thrombosis or pulmonary embolism.
5. History of iritis or episcleritis.
6. Thrombocytopenia \< 150 x 10\^9/L (\< 150,000/uL) at baseline evaluation.
7. Current treatment with lithium. Drug interactions between filgrastim and lithium, which may potentiate the release of neutrophils, have not been fully evaluated.
8. Positive Hemoglobin-Solubility (e.g., SickleDex or equivalent) test.
9. Donors receiving experimental therapy or investigational agents.
10. Positive pregnancy test collected/reported prior to start of filgrastim.

Contacts and Locations

Study Contact

Matthew Flores

CONTACT

763-406-3539

PBSCStudyTeam@nmdp.org

Principal Investigator

John P Miller, MD, PhD

PRINCIPAL_INVESTIGATOR

National Marrow Donor Program

Study Locations (Sites)

Gift of Life Bone Marrow Foundation

Boca Raton, Florida, 33431

United States

C.W. Bill Young Marrow Donor Center

Rockville, Maryland, 20852

United States

Be The Match

Minneapolis, Minnesota, 55401

United States

DKMS Americas

New York, New York, 10016

United States

Collaborators and Investigators

Sponsor: Center for International Blood and Marrow Transplant Research

John P Miller, MD, PhD, PRINCIPAL_INVESTIGATOR, National Marrow Donor Program

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date1997-02

Study Completion Date2030-01

Study Record Updates

Study Start Date1997-02

Study Completion Date2030-01

Terms related to this study

Keywords Provided by Researchers

Healthy Unrelated Stem Cell Donors

Additional Relevant MeSH Terms

Healthy