Filgrastim-Mobilized Stem Cells for Transplantation Using Unrelated Donors

Active:	Yes
Cancer Type:	Hematopoietic Malignancies	NCT ID:	NCT00785525
Trial Phases:	Phase III	Protocol IDs:	PBSC (primary) NCI-2014-00012
Eligibility:	18 - 60 Years, Male and Female	Study Type:	Other
Study Sponsor:	Center for International Blood and Marrow Transplant Research
NCI Full Details:	http://clinicaltrials.gov/show/NCT00785525

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

Objectives

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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