Filgrastim-Mobilized Stem Cells for Transplantation Using Unrelated Donors

Status: Active

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

Eligibility 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.

Locations & Contacts

Arizona

Scottsdale
Mayo Clinic in Arizona
Status: Active
Name Not Available

California

Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Contact: Shirong (Sean) Wang
Phone: 626-359-8111
Email: Wangsean21@gmail.com
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Farzam Hariri
Phone: 310-206-5756
Email: FHariri@mednet.ucla.edu

Florida

Jacksonville
Mayo Clinic in Florida
Status: Active
Name Not Available

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: Active
Name Not Available

Iowa

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: Active
Name Not Available

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: Active
Name Not Available

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: Active
Name Not Available

New York

Buffalo
Roswell Park Cancer Institute
Status: Active
Name Not Available

North Carolina

Durham
Duke University Medical Center
Status: Active
Name Not Available
Winston-Salem
Wake Forest University Health Sciences
Status: Active
Name Not Available

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: Active
Name Not Available

Trial Objectives and Outline

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.

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Not provided by clinicaltrials.gov

Lead Organization

Lead Organization
Center for International Blood and Marrow Transplant Research

Trial IDs

Primary ID PBSC
Secondary IDs NCI-2014-00012
Clinicaltrials.gov ID NCT00785525